Efficacy and safety of the fixed oral low-dose perindopril arginine 3.5 mg/amlodipine 2.5 mg combination compared with each component (perindopril arginine 3.5 mg and amlodipine 2.5 mg) and with perindopril arginine 5 mg and amlodipine 5 mg.Randomized, double-blind, placebo-controlled study over 8 weeks in hypertensive patients.
Phase 1
- Conditions
- Essential arterial hypertensionMedDRA version: 8.1Level: LLTClassification code 10020775Term: Hypertension arterial
- Registration Number
- EUCTR2006-005797-44-HU
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1500
Inclusion Criteria
- Men or women,
- 18 to 80 years old,
- Essential uncomplicated mild to moderate hypertensive patients
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- pregnancy,
- obesity,
- perindopril resistant hypertension,
- amlodipine resistant hypertension,
- secondary hypertension.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the superiority of the low-dose combination as compared to placebo and each component considered independently regarding blood pressure.;Secondary Objective: - To demonstrate that the response and normalisation rate on the fixed low-dose combination exceed that on placebo and show a trend towards better response and normalisation rate as compared to perindopril and amlodipine.<br>- To show a trend towards better safety regarding the low-dose fixed combination as compared to perindopril and to amlodipine.;Primary end point(s): Change in supine diastolic blood pressure
- Secondary Outcome Measures
Name Time Method