CompletedNCT02002702Updated Oct 12, 2015Results posted

Study of Safety, Tolerability and Pharmacokinetics of Serelaxin in Japanese Acute Heart Failure (AHF) Patients

A Phase 2 interventional study of Serelaxin and Placebo in Acute Heart Failure, sponsored by Novartis Pharmaceuticals. Completed at 15 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-10-12.

Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 46
Allocation: Randomized
Ages: 20 Years and older
Sex: All

Study summary

This is a multicenter, randomized, double-blind, placebo-controlled study to assess safety, tolerability and pharmacokinetics and to explore efficacy of IV infusion of 10 µg/kg/day and 30 µg/kg/day serelaxin for 48 hours compared to placebo, when added to the standard therapy, in approximately 45 Japanese AHF patients.

Conditions studied

Acute Heart Failure

Browse trials for

Heart Failure 5,701

Keywords

Acute heart failure (AHF),
Japanese,
Safety and tolerability, Pharmacokinetics,
Renal Impairment

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 46 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key Inclusion Criteria:

Written informed consent must be obtained before any study-specific assessment is performed.
Male or female ≥20 years of age, with body weight ≥30 kg and ≤160 kg
Hospitalized for AHF; AHF is defined as including all of the followings measured at any time between presentation (including the emergency department) and the end of screening:
Dyspnea at rest or with minimal exertion
Pulmonary congestion on chest radiograph
BNP ≥350 pg/mL or NT-proBNP ≥1,400 pg/mL
SBP ≥125 mmHg at the start and at the end of screening
Able to be randomized within 16 hours from presentation to the hospital, including the emergency department
Received intravenous (IV) furosemide of at least 40 mg (or equivalent) at any time between presentation (this include outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute heart failure (HF) episode.
Impaired renal function defined as an estimated glomerular filtration rate (eGFR) between presentation and randomization of ≥ 25 and≤ 75 mL/min/1.73 m2, calculated using the Japanese formula

Key Exclusion Criteria:

Dyspnea primarily due to non-cardiac causes
Temperature >38.5°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment
Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.
AHF due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate \<45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of >130 beats per minute.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 46 participants (actual)

Study arms

Experimental
Serelaxin 10 mcg/kg/Day
Participants received 10 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
Drug: Serelaxin
Experimental
Serelaxin 30 mcg/kg/Day
Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
Drug: Serelaxin
Placebo comparator
Placebo
Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
Drug: Placebo

Interventions

DrugSerelaxin
Intravenous infusion
DrugPlacebo
Placebo

What researchers measure

Primary outcomes

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs and SAEs, AEs Requiring Dose Adjustment or Interruption and Additional Therapy
AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards. AEs leading to discontinuations, or requiring dose adjustment or interruptions and additional therapy were assessed.
Time frame: From start of study treatment up to Day 5 (for AEs); From start of study treatment up to Day 14 (for SAEs)
Maximum Plasma Concentration (Cmax) of Serelaxin
Maximum plasma concentration (Cmax) was defined as the peak level of serelaxin, derived from plasma concentration-time data, using a non-compartmental model approach.
Time frame: Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose)
Weight Adjusted Clearance (CL) of Serelaxin
Weight adjusted clearance (CL) was defined as the total body clearance of serelaxin after drug administration. CL was calculated as nominal infusion rate divided by Css, using a non-compartmental model approach.
Time frame: Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose)
Concentration at Steady-state (Css) of Serelaxin
Concentration at steady-state (Css) was defined as concentration at the state of equilibrium obtained at the end of a certain number of administrations. Css of serelaxin in plasma was calculated by using a non-compartmental model approach.
Time frame: Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose)

Secondary outcomes

Change From Baseline in Area Under the Curve (AUC) for Systolic Blood Pressure (SBP) Through 48 Hours of Infusion at Day 5
The area under the curve (AUC) was defined as area under the plasma concentration-time curve from time zero to time of the last time point with measurable concentration, calculated by a trapezoidal method. Systolic blood pressure was measured using a calibrated standard sphygmomanometer after the subject remained in sitting position for 3 minutes at clinic during the visit. Sample collected at: Baseline; 30 \& 60 minutes and then every hour for the first 6 hours of study drug infusion, and then every 3 hours during 48 hours of study drug infusion; every 3 hours until 12 hours following end of infusion, then every 6 hours for 48 hours and then every 24 hours until the earlier of Day 5 or discharge. AUC for SBP is standardized by dividing by the length of respective time ranges.
Time frame: Baseline, 48 hours, Day 5
Change From Baseline in Aldosterone Levels Through Day 14
Aldosterone biomarker was used to assess the effect of serelaxinin on fluid retention. Geometric means of the ratio of post-Baseline values to baseline values of aldosterone was calculated by treatment for the full analysis set.
Time frame: Baseline, Day 1, Day 2, Day 5, Day 14
Change From Baseline in Cystatin-C Levels Through Day 14
Cystatin-C biomarker was used to assess the effect of serelaxinin on worsening of renal function. Geometric means of the ratio of post-Baseline values to baseline values of Cystatin-C was calculated by treatment for the full analysis set.
Time frame: Baseline, Day 1, Day 2, Day 5, Day 14
Change From Baseline in High Sensitivity Troponin-T Levels Through Day 14
High sensitivity Troponin-T biomarker was used to assess the effect of serelaxin on myocardial damage. Geometric means of the ratio of post-Baseline values to baseline values of high sensitivity troponin-t was calculated by treatment for the full analysis set.
Time frame: Baseline, Day 1, Day 2, Day 5, Day 14
Change From Baseline in NT-proBNP Levels Through Day 14
NT-proBNP biomarker was used to assess the effect of serelaxinin on degree of cardiac wall stress and congestion. Geometric means of the ratio of post-Baseline values to baseline values of NT-proBNP was calculated by treatment for the full analysis set.
Time frame: Baseline, Day 1, Day 2, Day 5, Day 14
Change From Baseline in Neutrophil Gelatinase-asc Lipocalin (NGAL) Levels Through Day 14
Neutrophil gelatinase-asc lipocalin (NGAL) biomarker was used to assess the effect of serelaxin on kidney function. Geometric means of the ratio of post-Baseline values to baseline values of NGAL was calculated by treatment for the full analysis set.
Time frame: Baseline, Day 1, Day 2, Day 5, Day 14

Results

Posted Oct 12, 2015

Participant flow

The study was conducted at 15 centers in Japan.

Participant flow — Overall Study
Milestone	Serelaxin 10 mcg/kg/Day	Serelaxin 30 mcg/kg/Day	Placebo
Started	16	15	15
Completed	16	15	15
Not completed	0	0	0

Outcome measures

PrimaryNumber of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs and SAEs, AEs Requiring Dose Adjustment or Interruption and Additional Therapy

AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards. AEs leading to discontinuations, or requiring dose adjustment or interruptions and additional therapy were assessed.

Time frame:: From start of study treatment up to Day 5 (for AEs); From start of study treatment up to Day 14 (for SAEs)
Reported as:: Number · participants

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs and SAEs, AEs Requiring Dose Adjustment or Interruption and Additional Therapy
participants	Serelaxin 10 mcg/kg/Day	Serelaxin 30 mcg/kg/Day	Placebo
AEs	10	11	9
SAEs	1	3	0
Death	0	0	0
Discontinuation due to AE(s)	0	2	0
Discontinuation due to SAE(s)	0	0	0
AEs requiring dose adjustment or interruption	0	1	0
AEs requiring additional therapy	8	10	9
AEs related to study drug	2	2	0

PrimaryMaximum Plasma Concentration (Cmax) of Serelaxin

Maximum plasma concentration (Cmax) was defined as the peak level of serelaxin, derived from plasma concentration-time data, using a non-compartmental model approach.

Time frame:: Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose)
Reported as:: Mean · nanogram(s)/milliliter (ng/mL)

Maximum Plasma Concentration (Cmax) of Serelaxin
nanogram(s)/milliliter (ng/mL)	Serelaxin 10 mcg/kg/Day	Serelaxin 30 mcg/kg/Day
Maximum Plasma Concentration (Cmax) of Serelaxin	8.01 ± 2.07	19.2 ± 4.69

PrimaryWeight Adjusted Clearance (CL) of Serelaxin

Weight adjusted clearance (CL) was defined as the total body clearance of serelaxin after drug administration. CL was calculated as nominal infusion rate divided by Css, using a non-compartmental model approach.

Time frame:: Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose)
Reported as:: Mean · mL/hr/kg

Weight Adjusted Clearance (CL) of Serelaxin
mL/hr/kg	Serelaxin 10 mcg/kg/Day	Serelaxin 30 mcg/kg/Day
Weight Adjusted Clearance (CL) of Serelaxin	56.8 ± 15.4	70.2 ± 23.2

PrimaryConcentration at Steady-state (Css) of Serelaxin

Concentration at steady-state (Css) was defined as concentration at the state of equilibrium obtained at the end of a certain number of administrations. Css of serelaxin in plasma was calculated by using a non-compartmental model approach.

Time frame:: Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose)
Reported as:: Mean · ng/mL

Concentration at Steady-state (Css) of Serelaxin
ng/mL	Serelaxin 10 mcg/kg/Day	Serelaxin 30 mcg/kg/Day
Concentration at Steady-state (Css) of Serelaxin	7.81 ± 1.96	19.1 ± 4.61

SecondaryChange From Baseline in Area Under the Curve (AUC) for Systolic Blood Pressure (SBP) Through 48 Hours of Infusion at Day 5

The area under the curve (AUC) was defined as area under the plasma concentration-time curve from time zero to time of the last time point with measurable concentration, calculated by a trapezoidal method. Systolic blood pressure was measured using a calibrated standard sphygmomanometer after the subject remained in sitting position for 3 minutes at clinic during the visit. Sample collected at: Baseline; 30 \& 60 minutes and then every hour for the first 6 hours of study drug infusion, and then every 3 hours during 48 hours of study drug infusion; every 3 hours until 12 hours following end of infusion, then every 6 hours for 48 hours and then every 24 hours until the earlier of Day 5 or discharge. AUC for SBP is standardized by dividing by the length of respective time ranges.

Time frame:: Baseline, 48 hours, Day 5
Reported as:: Least squares mean · mmHg

Change From Baseline in Area Under the Curve (AUC) for Systolic Blood Pressure (SBP) Through 48 Hours of Infusion at Day 5
mmHg	Serelaxin 10 mcg/kg/Day	Serelaxin 30 mcg/kg/Day	Placebo
48 hours	-8.21 ± 2.903	-18.6 ± 3.018	-10.88 ± 3.018
Day 5	-8.79 ± 2.761	-22.14 ± 2.871	-14.77 ± 2.871

SecondaryChange From Baseline in Aldosterone Levels Through Day 14

Aldosterone biomarker was used to assess the effect of serelaxinin on fluid retention. Geometric means of the ratio of post-Baseline values to baseline values of aldosterone was calculated by treatment for the full analysis set.

Time frame:: Baseline, Day 1, Day 2, Day 5, Day 14
Reported as:: Geometric mean · Ratio

Change From Baseline in Aldosterone Levels Through Day 14
Ratio	Serelaxin 10 mcg/kg/Day	Serelaxin 30 mcg/kg/Day	Placebo
Day 1	0.985 (0.7636 to 1.2717)	0.816 (0.6118 to 1.0897)	0.791 (0.6374 to 0.9825)
Day 2	0.975 (0.7492 to 1.2685)	0.721 (0.5195 to 0.9999)	0.911 (0.7141 to 1.1620)
Day 5	0.895 (0.6327 to 1.2656)	0.825 (0.6468 to 1.0531)	0.816 (0.5352 to 1.2452)
Day 14	1.510 (0.9934 to 2.2962)	1.114 (0.7983 to 1.5555)	1.179 (0.8337 to 1.6661)

SecondaryChange From Baseline in Cystatin-C Levels Through Day 14

Cystatin-C biomarker was used to assess the effect of serelaxinin on worsening of renal function. Geometric means of the ratio of post-Baseline values to baseline values of Cystatin-C was calculated by treatment for the full analysis set.

Time frame:: Baseline, Day 1, Day 2, Day 5, Day 14
Reported as:: Geometric mean · Ratio

Change From Baseline in Cystatin-C Levels Through Day 14
Ratio	Serelaxin 10 mcg/kg/Day	Serelaxin 30 mcg/kg/Day	Placebo
Day 1	0.921 (0.8863 to 0.9565)	0.988 (0.9213 to 1.0598)	0.985 (0.9291 to 1.0450)
Day 2	0.930 (0.8736 to 0.9900)	0.852 (0.6465 to 1.1236)	0.965 (0.9002 to 1.0346)
Day 5	1.062 (0.9898 to 1.1384)	1.115 (1.0207 to 1.2178)	1.038 (0.9627 to 1.1194)
Day 14	1.195 (1.0154 to 1.4057)	1.136 (1.0348 to 1.2472)	1.125 (1.0313 to 1.2271)

SecondaryChange From Baseline in High Sensitivity Troponin-T Levels Through Day 14

High sensitivity Troponin-T biomarker was used to assess the effect of serelaxin on myocardial damage. Geometric means of the ratio of post-Baseline values to baseline values of high sensitivity troponin-t was calculated by treatment for the full analysis set.

Time frame:: Baseline, Day 1, Day 2, Day 5, Day 14
Reported as:: Geometric mean · Ratio

Change From Baseline in High Sensitivity Troponin-T Levels Through Day 14
Ratio	Serelaxin 10 mcg/kg/Day	Serelaxin 30 mcg/kg/Day	Placebo
Day 1	0.899 (0.7598 to 1.0643)	1.060 (0.8932 to 1.2572)	0.956 (0.8652 to 1.0559)
Day 2	0.856 (0.6935 to 1.0553)	1.040 (0.8514 to 1.2714)	0.894 (0.7650 to 1.0442)
Day 5	0.849 (0.5984 to 1.2044)	0.972 (0.7779 to 1.2151)	0.779 (0.5250 to 1.1572)
Day 14	0.820 (0.5729 to 1.1730)	0.813 (0.4480 to 1.4748)	0.685 (0.4652 to 1.0093)

SecondaryChange From Baseline in NT-proBNP Levels Through Day 14

NT-proBNP biomarker was used to assess the effect of serelaxinin on degree of cardiac wall stress and congestion. Geometric means of the ratio of post-Baseline values to baseline values of NT-proBNP was calculated by treatment for the full analysis set.

Time frame:: Baseline, Day 1, Day 2, Day 5, Day 14
Reported as:: Geometric mean · Ratio

Change From Baseline in NT-proBNP Levels Through Day 14
Ratio	Serelaxin 10 mcg/kg/Day	Serelaxin 30 mcg/kg/Day	Placebo
Day 1	0.585 (0.4356 to 0.7865)	0.646 (0.5146 to 0.8115)	0.673 (0.5416 to 0.8363)
Day 2	0.492 (0.3421 to 0.7076)	0.451 (0.3271 to 0.6210)	0.581 (0.4410 to 0.7656)
Day 5	0.388 (0.2502 to 0.6028)	0.386 (0.2575 to 0.5796)	0.526 (0.3685 to 0.7503)
Day 14	0.295 (0.1649 to 0.5293)	0.419 (0.2621 to 0.6691)	0.277 (0.1875 to 0.4079)

SecondaryChange From Baseline in Neutrophil Gelatinase-asc Lipocalin (NGAL) Levels Through Day 14

Neutrophil gelatinase-asc lipocalin (NGAL) biomarker was used to assess the effect of serelaxin on kidney function. Geometric means of the ratio of post-Baseline values to baseline values of NGAL was calculated by treatment for the full analysis set.

Time frame:: Baseline, Day 1, Day 2, Day 5, Day 14
Reported as:: Geometric mean · Ratio

Change From Baseline in Neutrophil Gelatinase-asc Lipocalin (NGAL) Levels Through Day 14
Ratio	Serelaxin 10 mcg/kg/Day	Serelaxin 30 mcg/kg/Day	Placebo
Day 1	1.011 (0.8911 to 1.1478)	1.083 (0.9025 to 1.2996)	1.054 (0.9574 to 1.1613)
Day 2	0.929 (0.8443 to 1.0229)	1.172 (0.9994 to 1.3736)	1.099 (0.9866 to 1.2236)
Day 5	1.129 (1.0145 to 1.2560)	1.238 (1.0139 to 1.5114)	1.135 (1.0141 to 1.2698)
Day 14	1.434 (1.1760 to 1.7489)	1.520 (1.3214 to 1.7485)	1.433 (1.1793 to 1.7401)

Adverse events

Collected over Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Serelaxin 10 mcg/kg/Day	—	1/16 (6.3%)	10/16 (62.5%)
Serelaxin 30 mcg/kg/Day	—	3/15 (20%)	9/15 (60%)
Placebo	—	0/15 (0%)	9/15 (60%)

Most frequent serious events

Showing 10 of 12

Most frequent serious events
Event	Serelaxin 10 mcg/kg/Day	Serelaxin 30 mcg/kg/Day	Placebo
CARDIAC FAILURECardiac disorders	0/16	1/15	0/15
CORONARY ARTERY STENOSISCardiac disorders	0/16	1/15	0/15
VENTRICULAR TACHYCARDIACardiac disorders	0/16	1/15	0/15
INTESTINAL ISCHAEMIAGastrointestinal disorders	0/16	1/15	0/15
GASTRIC CANCERNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/16	1/15	0/15
METASTASES TO LIVERNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/16	1/15	0/15
METASTASES TO LYMPH NODESNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/16	1/15	0/15
METASTASES TO PERITONEUMNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/16	1/15	0/15
OESOPHAGEAL CARCINOMANeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/16	1/15	0/15
ATRIAL FIBRILLATIONCardiac disorders	1/16	0/15	0/15

Most frequent other events

Showing 10 of 34

Most frequent other events
Event	Serelaxin 10 mcg/kg/Day	Serelaxin 30 mcg/kg/Day	Placebo
CONSTIPATIONGastrointestinal disorders	0/16	4/15	1/15
CARDIAC FAILURECardiac disorders	0/16	1/15	3/15
HYPOKALAEMIAMetabolism and nutrition disorders	0/16	2/15	2/15
IRON DEFICIENCY ANAEMIABlood and lymphatic system disorders	0/16	0/15	1/15
ATRIAL FIBRILLATIONCardiac disorders	0/16	0/15	1/15
VENTRICULAR TACHYCARDIACardiac disorders	0/16	1/15	0/15
NAUSEAGastrointestinal disorders	0/16	0/15	1/15
BACTERIAL INFECTIONInfections and infestations	0/16	0/15	1/15
INFECTIONInfections and infestations	0/16	0/15	1/15
INFLUENZAInfections and infestations	0/16	1/15	0/15

Baseline characteristics

The analysis was performed on safety population defined as all randomized participants received any amount of study drug and had at least one post-baseline safety assessment.

Age, Continuous
Age, Continuous(years)	Serelaxin 10 mcg/kg/Day	Serelaxin 30 mcg/kg/Day	Placebo	Total
Mean	70.2 ± 11.77	79.7 ± 9.01	76.4 ± 12.08	75.3 ± 11.54

Age, Customized
Age, Customized(participants)	Serelaxin 10 mcg/kg/Day	Serelaxin 30 mcg/kg/Day	Placebo	Total
< 65 years	6	1	3	10
≥ 65 years	10	14	12	36

Sex: Female, Male
Sex: Female, Male(Participants)	Serelaxin 10 mcg/kg/Day	Serelaxin 30 mcg/kg/Day	Placebo	Total
Female	4	5	3	12
Male	12	10	12	34

Study locations

15 sites

Novartis Investigative Site
Seto-city, Aichi 489-8642, Japan
Novartis Investigative Site
Fukuoka-city, Fukuoka 810-0001, Japan
Novartis Investigative Site
Iizuka-city, Fukuoka 820-8505, Japan
Novartis Investigative Site
Hiroshima-city, Hiroshima 730-8518, Japan
Novartis Investigative Site
Amagasaki-city, Hyogo 660-8550, Japan
Novartis Investigative Site
Higashiibaraki-gun, Ibaraki 311-3193, Japan
Novartis Investigative Site
Kanazawa, Ishikawa 920-8650, Japan
Novartis Investigative Site
Kawasaki-city, Kanagawa 211-8533, Japan
Novartis Investigative Site
Yokohama-city, Kanagawa 231-8682, Japan
Novartis Investigative Site
Sendai-city, Miyagi 981-3107, Japan
Novartis Investigative Site
Ueda-city, Nagano 386-8610, Japan
Novartis Investigative Site
Osaka-city, Osaka 534-0021, Japan
Novartis Investigative Site
Sayama-city, Saitama 350-1323, Japan
Novartis Investigative Site
Komatsushima-city, Tokushima 773-8502, Japan
Novartis Investigative Site
Itabashi-ku, Tokyo 173-8610, Japan

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02002702
Lead sponsor: Novartis Pharmaceuticals
Responsible party: Sponsor
First posted: Dec 6, 2013
Start date: Jan 2014
Primary completion: Aug 2014
Completion: Aug 2014
Results posted: Oct 12, 2015
Last update: Oct 12, 2015

Study contacts

Novartis Pharmaceuticals

study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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