Study of Co-administration of Olmesartan Medoxomil Plus Amlodipine in Patients With Mild to Severe Hypertension
Phase 3
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00185133
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
This study assesses the efficacy and safety of co-administration of olmesartan medoxomil plus amlodipine in mild to severe hypertensive patients older than 18 years of age
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1900
Inclusion Criteria
- Male or female patients
- 18 years of age or older (20% equal to or older than 65 years)
- With mild to severe hypertension defined as seated diastolic blood pressure of 95-120 mmHg while off any hypertensive medication
Exclusion Criteria
- Patients should not have serious concomitant conditions that could interfere with the analysis of the results or that could interfere with the well-being of the patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in trough seated systolic blood pressure and seated diastolic blood pressure for each treatment arm
- Secondary Outcome Measures
Name Time Method To evaluate the number (%) of patients achieving BP goal. To characterize the pharmacokinetic interactions and the corresponding pharmacodynamic (BP) correlation