NCT00857285
Completed
Phase 3
A Multi-center, Double Blind, Efficacy, and Safety Study of the Oral Angiotensin II Receptor Blocker "Olmesartan Medoxomil" Versus "Losartan" in Patients With Mild to Moderate Essential Hypertension
ConditionsEssential Hypertension
Overview
- Phase
- Phase 3
- Intervention
- olmesartan medoxomil
- Conditions
- Essential Hypertension
- Sponsor
- Daiichi Sankyo
- Enrollment
- 130
- Locations
- 3
- Primary Endpoint
- Mean Change of Sitting dBP From Baseline to Week 12
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
The purpose of this study is to determine the efficacy and safety of oral administration of olmesartan medoxomil compared to losartan in subjects with mild to moderate hypertension.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diastolic BP 95 mm Hg - 114 mm Hg inclusive
- •No participation in any clinical trial for the last 3 months
Exclusion Criteria
- •Secondary hypertension
- •Malignant hypertension
- •Severe arterial hypertension
- •Significant cardiovascular disease
- •History or clinical evidence of cerebrovascular, gastrointestinal, hematological, hepatic disease, myocardial infarction, or severe liver disorder
- •Clinical evidence of renal disease, poorly controlled diabetes, known malabsorption syndromes, psychiatric/emotional problems
Arms & Interventions
1
olmesartan medoxomil
Intervention: olmesartan medoxomil
2
losartan potassium
Intervention: losartan potassium
Outcomes
Primary Outcomes
Mean Change of Sitting dBP From Baseline to Week 12
Time Frame: Baseline to 12 weeks
The difference in the sitting diastolic blood pressure (dBP) at trough, i.e. 24±2 hours after drug administration, from base line to Week 12.
Study Sites (3)
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