A Phase 3 interventional study of Placebo tamsulosin hydrochloride OCAS 0.4 mg and Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg in Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, sponsored by Astellas Pharma Europe B.V.. Completed at 118 sites in 13 countries. Open to male participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2024-12-03.
Sponsored by Astellas Pharma Europe B.V. (part of Astellas Pharma Inc) · Phase 3, Interventional, and Treatment
Clinical study to examine the efficacy, safety and tolerability of combination therapy of tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin hydrochloride in the treatment of males with LUTS associated with BPH with a substantial storage component.
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Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Drug: Placebo tamsulosin hydrochloride OCAS 0.4 mg · Drug: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg · Drug: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg
Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Drug: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg · Drug: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg · Drug: tamsulosin hydrochloride OCAS 0.4 mg
Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Drug: Placebo tamsulosin hydrochloride OCAS 0.4 mg · Drug: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg · Drug: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)
Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Drug: Placebo tamsulosin hydrochloride OCAS 0.4 mg · Drug: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg · Drug: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)
tablet
tablet
tablet
tablet
Also known as: Harnal ®, Omnic®, Flomax®, YM617
Drug pages: Tamsulosin · Solifenacin
tablet
Also known as: Vesomni, EC905
Drug pages: Tamsulosin · Solifenacin
tablet
Also known as: EC905
Change From Baseline to End of Treatment in Total International Prostate Symptom Score
The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: •Incomplete emptying of the bladder •Intermittency •Weak stream •Hesitancy •Frequency •Urgency •Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic).
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])
The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale: - 0. No urgency; - 1. Mild urgency; - 2. Moderate urgency; - 3. Severe urgency; - 4. Urgency incontinence TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
A micturition is any voluntary urination, excluding episodes of incontinence only.The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition
A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition
A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours
An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours
A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours
The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in IPSS Voiding Score
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic).
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in IPSS Storage Score
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 storage questions (frequency, urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic).
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in IPSS QoL Score
The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible).
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Individual IPSS Scores
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: •Incomplete emptying of the bladder •Intermittency •Weak stream •Hesitancy •Frequency •Urgency •Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Symptom Bother Score
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Health Related QoL (HRQoL) Subscale: Coping Score
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: - coping - concern - sleep - social interaction Coping score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in HRQoL Subscale: Concern Score
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: •coping •concern •sleep •social interaction Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in HRQoL Subscale: Sleep Score
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: •coping •concern •sleep •social interaction Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in HRQoL Subscale: Social Score
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: •coping •concern •sleep •social interaction Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in HRQoL Subscale: Total Score
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: •coping •concern •sleep •social interaction Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Time frame: Baseline and Week 12
Percentage of Participants Who Were OAB-q Responders at End of Treatment
A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10.
Time frame: Week 12 (end of treatment)
Change From Baseline to End of Treatment in EQ-5D Mobility Score
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: - mobility - self-care - usual activity - pain/discomfort - anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed).
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in EQ-5D Self-care Score
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: - mobility - self-care - usual activity - pain/discomfort - anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress).
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: - mobility - self-care - usual activity - pain/discomfort - anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities).
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: - mobility - self-care - usual activity - pain/discomfort - anxiety/depression Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain).
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: - mobility - self-care - usual activity - pain/discomfort - anxiety/depression Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious).
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score
Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state).
Time frame: Baseline and Week 12
Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms
The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse).
Time frame: Baseline and Week 12
Patient Global Impression Scale at End of Treatment: General Health
The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse).
Time frame: Baseline and Week 12
Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms
The Clinician Global Impression (CGI) is a questionnaire completed by the physician to assess change in the participants bladder symptoms since the start of the study. The questionnaire consists of 1 question with 7 response levels ranging from 1 to 7 (very much improved to very much worse).
Time frame: Baseline and Week 12
Number of Participants With Adverse Events (AEs)
Safety is monitored by collecting AEs, which include abnormal laboratory parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE (SAE) was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after administration of the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug.
Time frame: From first dose of double-blind study drug up to 14 days of last dose of double-blind study drug (up to 14 weeks)
Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume
PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
Qmax during a micturition (urination) was recorded using uroflowmetry.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Average Flow Rate (Qmean)
Qmean during a micturition (urination) was recorded using uroflowmetry.
Time frame: Baseline and Week 12
Apparent Clearance (CL/F) of Tamsulosin
Time frame: Week 4, Week 8 and Week 12
Maximum Concentration at Steady State (Cmaxss) of Tamsulosin
Time frame: Week 4, Week 8 and Week 12
Minimum Concentration at Steady State (Cminss) of Tamsulosin
Time frame: Week 4, Week 8 and Week 12
Time of Maximum Concentration at Steady State (Tmaxss) of Tamsulosin
Time frame: Week 4, Week 8 and Week 12
Area Under the Curve at Steady State (AUCss) of Tamsulosin
Time frame: Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)
CL/F of Solifenacin
Time frame: Week 4, Week 8 and Week 12
Cmaxss of Solifenacin
Time frame: Week 4, Week 8 and Week 12
Cminss of Solifenacin
Time frame: Week 4, Week 8 and Week 12
Tmaxss of Solifenacin
Time frame: Week 4, Week 8 and Week 12
AUCss of Solifenacin
Time frame: Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)
| Milestone | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Started | 341 | 327 | 339 | 327 |
| Randomized and treated | 341 | 326 | 338 | 324 |
| Completed | 315 | 295 | 299 | 294 |
| Not completed | 26 | 32 | 40 | 33 |
| Withdrew: Not fulfilling eligibility criteria | 6 | 7 | 7 | 3 |
| Withdrew: Adverse event | 5 | 9 | 13 | 10 |
| Withdrew: Lack of efficacy | 4 | 1 | 1 | 2 |
| Withdrew: Withdrawal by subject | 6 | 5 | 11 | 9 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 0 |
| Withdrew: Protocol violation | 5 | 8 | 7 | 9 |
| Withdrew: Miscellaneous | 0 | 2 | 0 | 0 |
The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: •Incomplete emptying of the bladder •Intermittency •Weak stream •Hesitancy •Frequency •Urgency •Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic).
| units on a scale | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in Total International Prostate Symptom Score | -5.4 ± 0.41 | -6.2 ± 0.42 | -7.0 ± 0.41 | -6.5 ± 0.42 |
The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale: - 0. No urgency; - 1. Mild urgency; - 2. Moderate urgency; - 3. Severe urgency; - 4. Urgency incontinence TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency.
| units on a scale | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS]) | -4.4 ± 0.68 | -6.7 ± 0.69 | -8.1 ± 0.67 | -7.6 ± 0.69 |
A micturition is any voluntary urination, excluding episodes of incontinence only.The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
| micturitions | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | -1.1 ± 0.16 | -1.7 ± 0.16 | -2.3 ± 0.16 | -1.9 ± 0.16 |
A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
| mL | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition | 11.1 ± 2.94 | 15.5 ± 3.02 | 38.6 ± 2.94 | 38.7 ± 3.01 |
A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
| mL | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition | -5.9 ± 6.43 | -1.8 ± 6.62 | 12.7 ± 6.45 | 12.9 ± 6.63 |
An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
| urgency episodes | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg 9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours | -1.6 ± 0.24 | -2.5 ± 0.25 | -2.6 ± 0.24 | -2.8 ± 0.25 |
An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
| urgency incontinence episodes | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours | -1.0 ± 0.15 | -1.4 ± 0.18 | -1.3 ± 0.16 | -1.1 ± 0.16 |
An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
| incontinence episodes | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | 0.1 ± 0.19 | -0.2 ± 0.22 | 0.0 ± 0.20 | 0.1 ± 0.19 |
A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
| nocturia episodes | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours | -0.3 ± 0.07 | -0.4 ± 0.08 | -0.5 ± 0.07 | -0.4 ± 0.07 |
The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
| pads | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours | -0.7 ± 0.23 | -0.8 ± 0.27 | -1.2 ± 0.24 | -1.2 ± 0.24 |
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic).
| units on a scale | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in IPSS Voiding Score | -3.0 ± 0.27 | -3.3 ± 0.28 | -3.7 ± 0.27 | -3.2 ± 0.28 |
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 storage questions (frequency, urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic).
| units on a scale | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in IPSS Storage Score | -2.4 ± 0.20 | -2.9 ± 0.20 | -3.5 ± 0.20 | -3.3 ± 0.21 |
The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible).
| units on a scale | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in IPSS QoL Score | -0.9 ± 0.11 | -1.0 ± 0.11 | -1.3 ± 0.11 | -1.3 ± 0.11 |
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: •Incomplete emptying of the bladder •Intermittency •Weak stream •Hesitancy •Frequency •Urgency •Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom.
| units on a scale | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Incomplete emptying of the bladder | -0.9 ± 1.54 | -0.9 ± 1.52 | -1.0 ± 1.63 | -1.0 ± 1.48 |
| Frequency | -1.0 ± 1.36 | -1.2 ± 1.42 | -1.3 ± 1.49 | -1.4 ± 1.41 |
| Intermittency | -0.9 ± 1.41 | -0.8 ± 1.35 | -1.0 ± 1.47 | -0.7 ± 1.34 |
| Urgency | -1.2 ± 1.55 | -1.3 ± 1.61 | -1.4 ± 1.51 | -1.6 ± 1.50 |
| Weak stream | -1.1 ± 1.54 | -1.3 ± 1.57 | -1.3 ± 1.51 | -1.3 ± 1.56 |
| Hesitancy | -0.5 ± 1.37 | -0.7 ± 1.26 | -0.8 ± 1.34 | -0.7 ± 1.29 |
| Nocturia | -0.5 ± 1.23 | -0.7 ± 1.08 | -0.8 ± 1.08 | -0.6 ± 1.15 |
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement.
| units on a scale | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in Symptom Bother Score | -11.8 ± 1.26 | -14.4 ± 1.28 | -16.5 ± 1.26 | -17.1 ± 1.28 |
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: - coping - concern - sleep - social interaction Coping score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
| units on a scale | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg 9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in Health Related QoL (HRQoL) Subscale: Coping Score | 8.8 ± 1.24 | 11.0 ± 1.26 | 13.9 ± 1.24 | 13.4 ± 1.26 |
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: •coping •concern •sleep •social interaction Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
| units on a scale | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in HRQoL Subscale: Concern Score | 7.5 ± 1.19 | 9.3 ± 1.21 | 12.0 ± 1.19 | 11.5 ± 1.21 |
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: •coping •concern •sleep •social interaction Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
| units on a scale | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in HRQoL Subscale: Sleep Score | 8.3 ± 1.31 | 8.8 ± 1.33 | 11.9 ± 1.31 | 10.0 ± 1.33 |
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: •coping •concern •sleep •social interaction Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
| units on a scale | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in HRQoL Subscale: Social Score | 3.8 ± 0.96 | 4.5 ± 0.97 | 6.2 ± 0.95 | 5.8 ± 0.97 |
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: •coping •concern •sleep •social interaction Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
| units on a scale | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in HRQoL Subscale: Total Score | 7.4 ± 1.06 | 8.8 ± 1.08 | 11.4 ± 1.06 | 10.7 ± 1.08 |
A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10.
| percentage of participants | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Percentage of Participants Who Were OAB-q Responders at End of Treatment | 40.8 | 42.9 | 45.5 | 47.5 |
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: - mobility - self-care - usual activity - pain/discomfort - anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed).
| participants | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| No problem -> No problem | 240 | 230 | 255 | 233 |
| No problem -> Some problem | 16 | 13 | 10 | 13 |
| No problem -> Confined to bed | 0 | 1 | 0 | 0 |
| No problem -> No data | 3 | 1 | 1 | 3 |
| Some problem -> No problem | 19 | 21 | 12 | 19 |
| Some problem -> Some problem | 40 | 31 | 35 | 31 |
| Some problem -> Confined to bed | 0 | 0 | 0 | 0 |
| Some problem -> No data | 0 | 0 | 0 | 1 |
| Confined to bed -> No problem | 0 | 0 | 0 | 0 |
| Confined to bed -> Some problem | 0 | 0 | 0 | 0 |
| Confined to bed -> Confined to bed | 0 | 0 | 0 | 0 |
| Confined to bed -> No data | 0 | 0 | 0 | 0 |
| No data -> No problem | 0 | 1 | 0 | 1 |
| No data -> Some problem | 0 | 0 | 0 | 0 |
| No data -> Confined to bed | 0 | 0 | 0 | 0 |
| No data -> No data | 0 | 0 | 0 | 0 |
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: - mobility - self-care - usual activity - pain/discomfort - anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress).
| participants | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| No problem -> No problem | 295 | 273 | 293 | 286 |
| No problem -> Some problem | 8 | 8 | 3 | 4 |
| No problem -> Unable to wash/ dress | 0 | 0 | 0 | 0 |
| No problem -> No Data | 3 | 1 | 1 | 4 |
| Some problem -> No problem | 8 | 6 | 8 | 3 |
| Some problem -> Some problem | 3 | 8 | 6 | 3 |
| Some problem -> Unable to wash/ dress | 0 | 0 | 0 | 0 |
| Some problem -> No data | 0 | 0 | 0 | 0 |
| Unable to wash/ dress -> No problem | 0 | 0 | 1 | 0 |
| Unable to wash/ dress -> Some problem | 0 | 0 | 0 | 0 |
| Unable to wash/ dress -> Unable to wash/ dress | 0 | 1 | 0 | 0 |
| Unable to wash/ dress -> No data | 0 | 0 | 0 | 0 |
| No data -> No problem | 1 | 1 | 1 | 1 |
| No data -> Some problem | 0 | 0 | 0 | 0 |
| No data -> Unable to wash/ dress | 0 | 0 | 0 | 0 |
| No data -> No data | 0 | 0 | 0 | 0 |
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: - mobility - self-care - usual activity - pain/discomfort - anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities).
| participants | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| No problem -> No problem | 254 | 228 | 248 | 235 |
| No problem -> Some problem | 18 | 13 | 14 | 18 |
| No problem -> Unable to perform usual activities | 0 | 1 | 0 | 0 |
| No problem -> No data | 3 | 1 | 1 | 3 |
| Some problem -> No problem | 21 | 22 | 26 | 27 |
| Some problem -> Some problem | 22 | 28 | 22 | 17 |
| Some problem -> Unable to perform usual activities | 0 | 0 | 0 | 0 |
| Some problem -> No data | 0 | 0 | 0 | 1 |
| Unable to perform usual activities -> No problem | 0 | 1 | 2 | 0 |
| Unable to perform usual activities -> Some problem | 0 | 1 | 0 | 0 |
| Unable to perform usual activities -> same status | 0 | 1 | 0 | 0 |
| Unable to perform usual activities -> No data | 0 | 0 | 0 | 0 |
| No data -> No problem | 0 | 2 | 0 | 0 |
| No data -> Some problem | 0 | 0 | 0 | 0 |
| No data -> Unable to perform usual activities | 0 | 0 | 0 | 0 |
| No data -> No data | 0 | 0 | 0 | 0 |
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: - mobility - self-care - usual activity - pain/discomfort - anxiety/depression Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain).
| participants | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| No pain -> No pain | 162 | 159 | 153 | 152 |
| No pain -> Moderate pain | 14 | 14 | 19 | 24 |
| No pain -> Extreme pain | 2 | 1 | 1 | 0 |
| No pain -> No data | 3 | 0 | 1 | 2 |
| Moderate pain-> No pain | 55 | 41 | 61 | 41 |
| Moderate pain-> Moderate pain | 73 | 72 | 72 | 70 |
| Moderate pain-> Extreme pain | 2 | 2 | 1 | 1 |
| Moderate pain-> No data | 0 | 2 | 0 | 2 |
| Extreme pain -> No pain | 0 | 1 | 1 | 3 |
| Extreme pain -> Moderate pain | 4 | 2 | 2 | 4 |
| Extreme pain -> Extreme pain | 1 | 2 | 2 | 2 |
| Extreme pain -> No data | 0 | 0 | 0 | 0 |
| No data -> No pain | 0 | 2 | 0 | 0 |
| No data -> Moderate pain | 2 | 0 | 0 | 0 |
| No data -> Extreme pain | 0 | 0 | 0 | 0 |
| No data -> No data | 0 | 0 | 0 | 0 |
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: - mobility - self-care - usual activity - pain/discomfort - anxiety/depression Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious).
| participants | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Not anxious -> Not anxious | 219 | 213 | 233 | 214 |
| Not anxious -> Moderately anxious | 16 | 11 | 16 | 18 |
| Not anxious -> Extremely anxious | 0 | 0 | 0 | 0 |
| Not anxious -> No data | 3 | 0 | 1 | 3 |
| Moderately anxious -> Not anxious | 34 | 25 | 27 | 25 |
| Moderately anxious -> Moderately anxious | 42 | 43 | 39 | 34 |
| Moderately anxious -> Extremely anxious | 1 | 2 | 1 | 1 |
| Moderately anxious -> No data | 0 | 1 | 0 | 1 |
| Extremely anxious -> Not anxious | 2 | 0 | 1 | 0 |
| Extremely anxious -> Moderately anxious | 0 | 0 | 1 | 3 |
| Extremely anxious -> Extremely anxious | 1 | 2 | 3 | 2 |
| Extremely anxious -> No data | 0 | 0 | 0 | 0 |
| No data -> Not anxious | 0 | 1 | 1 | 0 |
| No data -> Moderately anxious | 0 | 0 | 0 | 0 |
| No data -> Extremely anxious | 0 | 0 | 0 | 0 |
| No data -> No data | 0 | 0 | 0 | 0 |
Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state).
| units on a scale | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score | 4.0 ± 14.48 | 3.7 ± 12.69 | 5.5 ± 13.58 | 6.2 ± 15.52 |
The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse).
| participants | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Very Much Improved | 7 | 14 | 20 | 23 |
| Much Improved | 75 | 85 | 95 | 105 |
| Minimally Improved | 113 | 99 | 124 | 105 |
| No Change | 86 | 68 | 46 | 38 |
| Minimally Worse | 12 | 13 | 2 | 9 |
| Much Worse | 5 | 3 | 0 | 1 |
| Very Much Worse | 0 | 0 | 0 | 0 |
The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse).
| participants | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Very Much Improved | 5 | 9 | 10 | 7 |
| Much Improved | 43 | 58 | 72 | 75 |
| Minimally Improved | 79 | 77 | 87 | 94 |
| No Change | 152 | 126 | 110 | 94 |
| Minimally Worse | 15 | 9 | 8 | 10 |
| Much Worse | 2 | 3 | 0 | 1 |
| • Very Much Worse | 0 | 0 | 0 | 0 |
The Clinician Global Impression (CGI) is a questionnaire completed by the physician to assess change in the participants bladder symptoms since the start of the study. The questionnaire consists of 1 question with 7 response levels ranging from 1 to 7 (very much improved to very much worse).
| participants | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Very Much Improved | 9 | 15 | 22 | 20 |
| Much Improved | 95 | 106 | 117 | 124 |
| Minimally Improved | 111 | 98 | 97 | 92 |
| No Change | 72 | 54 | 48 | 37 |
| Minimally Worse | 9 | 5 | 2 | 3 |
| Much Worse | 1 | 1 | 1 | 4 |
| Very Much Worse | 0 | 0 | 0 | 0 |
Safety is monitored by collecting AEs, which include abnormal laboratory parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE (SAE) was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after administration of the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug.
| participants | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Total TEAEs | 87 | 74 | 99 | 100 |
| Mild TEAEs | 59 | 42 | 68 | 68 |
| Moderate TEAEs | 25 | 29 | 27 | 27 |
| Severe TEAEs | 3 | 3 | 4 | 5 |
| Drug-related TEAEs | 30 | 27 | 57 | 65 |
| SAEs | 3 | 10 | 5 | 9 |
| Deaths | 0 | 1 | 1 | 0 |
| AEs Leading to Discontin | 5 | 9 | 13 | 10 |
| Drug-related AEs Leading to Discontin | 3 | 5 | 9 | 8 |
PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan.
| mL | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume | -6.1 ± 36.39 | -5.0 ± 38.22 | 3.8 ± 45.39 | 12.3 ± 46.61 |
Qmax during a micturition (urination) was recorded using uroflowmetry.
| mL/s | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) | 3.3 ± 4.69 | 3.2 ± 4.62 | 3.8 ± 5.30 | 3.5 ± 5.35 |
Qmean during a micturition (urination) was recorded using uroflowmetry.
| mL/s | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Change From Baseline to End of Treatment in Average Flow Rate (Qmean) | 1.5 ± 2.61 | 1.3 ± 2.16 | 1.9 ± 2.75 | 1.7 ± 2.98 |
| L/h | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|
| Week 4 [N=263; 281; 274] | 2.78 ± 84.8 | 2.61 ± 85.8 | 2.53 ± 79.3 |
| Week 8 [N=255; 259; 248] | 2.62 ± 79.0 | 2.41 ± 79.5 | 2.36 ± 93.3 |
| Week 12 [N=163; 167; 166] | 2.52 ± 85.3 | 2.40 ± 74.1 | 2.46 ± 85.9 |
| ng/mL | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|
| Week 4 [N= 263; 281; 274] | 7.38 ± 82.8 | 7.80 ± 94.3 | 8.00 ± 83.3 |
| Week 8 [N= 255; 259; 248] | 7.69 ± 71.2 | 8.32 ± 73.4 | 8.46 ± 84.9 |
| Week 12 [N= 163; 167; 166] | 7.97 ± 68.6 | 8.38 ± 69.0 | 8.16 ± 82.7 |
| ng/mL | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|
| Week 4 [N= 263; 281; 274] | 4.19 ± 127.0 | 4.55 ± 146.0 | 4.75 ± 124.0 |
| Week 8 [N= 255; 259; 248] | 4.63 ± 103.0 | 5.08 ± 106.0 | 5.19 ± 122.0 |
| Week 12 [N= 163; 167; 166] | 4.84 ± 97.7 | 5.05 ± 96.2 | 4.94 ± 119.0 |
| h | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|
| Week 4 [N= 263; 281; 274] | 5.04 ± 4.1 | 5.06 ± 4.0 | 5.08 ± 3.6 |
| Week 8 [N= 255; 259; 248] | 5.09 ± 3.4 | 5.10 ± 3.3 | 5.11 ± 3.4 |
| Week 12 [N= 163; 167; 166] | 5.10 ± 3.6 | 5.09 ± 3.6 | 5.09 ± 3.3 |
| ng.h/mL | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|
| Week 4 [N= 263; 281; 274] | 144 ± 96.7 | 153 ± 111.0 | 158 ± 96.5 |
| Week 8 [N= 255; 259; 248] | 153 ± 81.6 | 166 ± 84.0 | 169 ± 96.9 |
| Week 12 [N= 163; 167; 166] | 159 ± 78.1 | 167 ± 77.4 | 162 ± 94.8 |
| L/h | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|
| Week 4 [N= 281;273] | 6.88 ± 53.6 | 7.00 ± 70.7 |
| Week 8 [N= 258; 248] | 6.72 ± 51.7 | 6.67 ± 61.3 |
| Week 12 [N= 166; 167] | 6.94 ± 59.3 | 6.87 ± 74.1 |
| ng/mL | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|
| Week 4 [N= 281; 273] | 29.4 ± 44.8 | 43.4 ± 51.4 |
| Week 8 [N= 258; 248] | 30.0 ± 48.0 | 45.3 ± 48.5 |
| Week 12 [N= 166; 167] | 29.1 ± 49.6 | 44.1 ± 50.7 |
| ng/mL | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|
| Week 4 [N= 281; 273] | 24.5 ± 50.5 | 36.1 ± 57.8 |
| Week 8 [N= 258; 248] | 25.2 ± 54.1 | 38.2 ± 54.3 |
| Week 12 [N= 166; 167] | 24.4 ± 55.6 | 37.0 ± 56.8 |
| h | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|
| Week 4 [N= 281; 273] | 5.47 ± 1.41 | 5.47 ± 1.2 |
| Week 8 [N= 258; 248] | 5.48 ± 0.9 | 5.48 ± 0.9 |
| Week 12 [N= 166; 167] | 5.48 ± 0.9 | 5.48 ± 0.9 |
| ng.h/mL | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|
| Week 4 [N= 281; 273] | 657 ± 46.8 | 970 ± 53.7 |
| Week 8 [N= 258; 248] | 673 ± 50.3 | 1020 ± 50.7 |
| Week 12 [N= 166; 167] | 652 ± 51.8 | 988 ± 53.0 |
Collected over From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 3/341 (0.9%) | 5/341 (1.5%) |
| TOCAS 0.4 mg | — | 10/326 (3.1%) | 3/326 (0.9%) |
| FDC 0.4 mg/6 mg | — | 5/337 (1.5%) | 36/337 (10.7%) |
| FDC 0.4 mg/9 mg | — | 9/324 (2.8%) | 43/324 (13.3%) |
| Event | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Urinary retentionRenal and urinary disorders | 1/341 | 1/326 | 1/337 | 3/324 |
| Atrial fibrillationCardiac disorders | 0/341 | 2/326 | 0/337 | 0/324 |
| Coronary artery stenosisCardiac disorders | 0/341 | 0/326 | 0/337 | 1/324 |
| Sick sinus syndromeCardiac disorders | 0/341 | 0/326 | 0/337 | 1/324 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/341 | 0/326 | 0/337 | 1/324 |
| Cerebrovascular accidentNervous system disorders | 0/341 | 0/326 | 0/337 | 1/324 |
| SyncopeNervous system disorders | 0/341 | 0/326 | 0/337 | 1/324 |
| BronchiectasisInfections and infestations | 0/341 | 0/326 | 0/337 | 1/324 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 0/341 | 0/326 | 0/337 | 1/324 |
| Angina pectorisCardiac disorders | 1/341 | 1/326 | 0/337 | 0/324 |
| Event | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg |
|---|---|---|---|---|
| Dry mouthGastrointestinal disorders | 4/341 | 2/326 | 29/337 | 34/324 |
| ConstipationGastrointestinal disorders | 1/341 | 1/326 | 12/337 | 18/324 |
Safety Analysis Set (SAF): participants who received at least 1 dose of double-blind study drug and had any data reported after the first dose; For study-specific: Full Analysis Set (FAS): participants who received at least 1 dose of double-blind study drug and had either a total IPSS or TUS at baseline and at least 1 postbaseline total IPSS or TUS
| Age, Continuous(years) | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg | Total |
|---|---|---|---|---|---|
| Mean | 65.6 ± 8.41 | 65.1 ± 7.98 | 65.3 ± 8.39 | 65.5 ± 7.71 | 65.4 ± 8.13 |
| Sex: Female, Male(Participants) | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg | Total |
|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 |
| Male | 341 | 326 | 337 | 324 | 1328 |
| Race/Ethnicity, Customized(participants) | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg | Total |
|---|---|---|---|---|---|
| White | 337 | 325 | 334 | 321 | 1317 |
| Black | 0 | 1 | 1 | 2 | 4 |
| Asian | 3 | 0 | 1 | 0 | 4 |
| Other | 1 | 0 | 1 | 1 | 3 |
| Total International Prostate Symptom Score (IPSS)(units on a scale) | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg | Total |
|---|---|---|---|---|---|
| Mean | 19.0 ± 4.48 | 18.7 ± 4.63 | 18.3 ± 4.31 | 18.6 ± 4.31 | 18.6 ± 4.44 |
| IPSS voiding score(units on a scale) | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg | Total |
|---|---|---|---|---|---|
| Mean | 10.0 ± 3.53 | 9.8 ± 3.63 | 9.7 ± 3.61 | 9.7 ± 3.63 | 9.8 ± 3.60 |
| IPSS storage score(units on a scale) | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg | Total |
|---|---|---|---|---|---|
| Mean | 9.0 ± 2.42 | 8.9 ± 2.33 | 8.6 ± 2.39 | 8.8 ± 2.36 | 8.8 ± 2.38 |
| IPSS Quality of Life (QoL) score(units on a scale) | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg | Total |
|---|---|---|---|---|---|
| Mean | 4.1 ± 1.12 | 4.1 ± 1.07 | 4.0 ± 1.15 | 4.1 ± 1.08 | 4.1 ± 1.11 |
| Total Urgency Frequency Score (TUFS) (previously known as Total Urgency Score ([TUS])(units on a scale) | Placebo | TOCAS 0.4 mg | FDC 0.4 mg/6 mg | FDC 0.4 mg/9 mg | Total |
|---|---|---|---|---|---|
| Mean | 27.15 ± 8.80 | 27.85 ± 9.02 | 26.97 ± 8.66 | 26.39 ± 8.34 | 27.09 ± 8.71 |
6 further baseline measures are reported on the registry.
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Plan to share: Yes — Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Data sharing details ↗ · www.clinicaltrials.astellas.com
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Tamsulosin · Solifenacin