A Phase 4 interventional study of olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary in Essential Hypertension, sponsored by Daiichi Sankyo. Completed. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-06-03.
Sponsored by Daiichi Sankyo · Phase 4, Interventional, and Treatment
In patients naive to treatment or after a 2-week washout period for patients whose treatment was ineffective, the use of olmesartan was assessed in a 4-phase treatment scheme: monotherapy, addition of hydrochlorothiazide (2 phases), addition of amlodipine.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 144 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Daiichi Sankyo is the lead sponsor of 316 studies on the registry; 35 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.
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Exclusion Criteria:
Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary
olmesartan medoxomil tablets,or olmesartan medoxomil/hydrochlorothiazide tablets, if necessary + amlodipine tablets, if necessary. All interventions are once-daily for 4 to 9 weeks
Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy)
Number of patients that achieved a blood pressure (BP) goal of less than 130/85 in the first group (olmesartan monotherapy 20 mg). If BP was \> or = to 140/90 at 4,8, or 9 wks the participant went to next level for an additional 4-9 weeks at the next medication level
Time frame: 4 - 9 wks of olmesartan monotherapy
Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in First Titrated Group (Olmesartan 20 mg + 12.5 mg Hydrochlorothiazide)
Number of patients that achieved a blood pressure goal of less than 130/85 in first titrated group (olmesartan 20 mg + 12.5 mg hydrochlorothiazide)If BP was \> or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks
Time frame: 4 to 9 weeks on combination therapy
Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide)
Number of patients that achieved a blood pressure goal of less than 130/85 in second titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide). If BP was \> or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks.
Time frame: 4 to 9 weeks
Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine)
Number of patients that achieved a blood pressure goal of less than 130/85 in third titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide + amlodipine 5 mg). This combination was maintained as long as the participant's blood pressure remained within predefined parameters. If not, participant discontinued for lack of efficacy.
Time frame: 4 - 9 weeks
The study pop. was defined by the inclusion criteria. This study was carried out in 14 centers in Brazil with inclusion 2 months after the first study subject, started in Aug 06. After the screening visit, the patients that met inclusion and exclusion criteria were selected to participate in the study. The last patient out was in Jul 07.
| Milestone | Olmesartan + Hydrochlorothiazide + Amlodipine |
|---|---|
| Started | 144 |
| Completed | 124 |
| Not completed | 20 |
| Withdrew: Lack of efficacy | 20 |
Number of patients that achieved a blood pressure (BP) goal of less than 130/85 in the first group (olmesartan monotherapy 20 mg). If BP was \> or = to 140/90 at 4,8, or 9 wks the participant went to next level for an additional 4-9 weeks at the next medication level
| Participants | Olmesartan Monotherapy |
|---|---|
| Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy) | 38 |
Number of patients that achieved a blood pressure goal of less than 130/85 in first titrated group (olmesartan 20 mg + 12.5 mg hydrochlorothiazide)If BP was \> or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks
| Participants | Olmesartan + Hydrochlorothiazide |
|---|---|
| Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in First Titrated Group (Olmesartan 20 mg + 12.5 mg Hydrochlorothiazide) | 33 |
Number of patients that achieved a blood pressure goal of less than 130/85 in second titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide). If BP was \> or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks.
| Participants | Olmesartan + Hydrochlorothiazide |
|---|---|
| Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide) | 41 |
Number of patients that achieved a blood pressure goal of less than 130/85 in third titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide + amlodipine 5 mg). This combination was maintained as long as the participant's blood pressure remained within predefined parameters. If not, participant discontinued for lack of efficacy.
| Participants | Olmesartan + Hydrochlorothiazide + Amlodipine |
|---|---|
| Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine) | 12 |
| Age, Categorical(Participants) | Olmesartan + Hydrochlorothiazide + Amlodipine |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 132 |
| >=65 years | 12 |
| Sex: Female, Male(Participants) | Olmesartan + Hydrochlorothiazide + Amlodipine |
|---|---|
| Female | 74 |
| Male | 70 |
| Race/Ethnicity, Customized(Participants) | Olmesartan + Hydrochlorothiazide + Amlodipine |
|---|---|
| Black | 24 |
| White | 83 |
| Asian | 7 |
| Other | 30 |
| Region of Enrollment(participants) | Olmesartan + Hydrochlorothiazide + Amlodipine |
|---|---|
| Brazil | 144 |
No study locations are listed for this record.
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Daiichi Sankyo