Phase 4
N=144
Efficacy and Safety of Olmesartan Medoxomil in Stage 1 and 2 Essential Hypertension
Essential Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00890591 ↗Enrolled (actual)
144
Serious AEs
—
Results posted
Apr 2009
Primary outcome: Primary: Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy) — 38 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo
- Primary completion
- Jun 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy) |
38 | — |
| PRIMARY 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 | — |
| PRIMARY 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 | — |
| PRIMARY Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine) |
12 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Stage 1 and 2 hypertension without treatment for at least 2 weeks
- Women with no risk of becoming pregnant
Exclusion Criteria
- Study participation could result in risk to health of subject
- Cardiovascular disease
- Secondary hypertension or stage 3 hypertension
- Myocardial infarction within the last 6 months
- Congestive heart failure
- Pulmonary edema
- Valvular alterations or rheumatic cardiopathy
- Clinically relevant conduction disorders significant arrhythmias
- Alcohol or illicit drug use
- Medication abuse
- Pregnant or nursing women
Data sourced from ClinicalTrials.gov (NCT00890591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.