Perindopril Amlodipine Regimen versus AT1-Receptor Blocker/thiazide: a comparison of Blood pressure Lowering: Efficacy and Safety.A randomised, double blind, 9 month study of the efficacy and safety of four uptitrated doses of oral fixed combinations of perindopril/amlodipine, including a comparison with uptitrated doses of oral fixed combination of irbesartan and hydrochlorthiazide in mild to moderate hypertension.
- Conditions
- Essential arterial hypertensionMedDRA version: 9.1Level: LLTClassification code 10020775Term: Hypertension arterial
- Registration Number
- EUCTR2006-005799-42-IE
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3000
Inclusion Criteria
- Outpatients,
- Men or women,
- 18 years old at least,
- Mild to moderate hypertensive patient.
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
- Pregnant or breastfeeding women,
- Secondary hypertension,
- Any patient suffering from an acute or chronic illness.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To assess the efficacy of each dose increase of perindopril/amlodipine combination on blood pressure normalisation during a 6-month period.<br>- To assess the safety of the perindopril/amlodipine combination for the 9 month duration of the trial, (minimum of 6 month exposure for the highest dose).;Secondary Objective: To compare perindopril/amlodipine combination strategy versus irbesartan/hydrochlorothiazide combination strategy changes in blood pressure parameters after 6 months;Primary end point(s): Proportion of participants with controlled blood pressure
- Secondary Outcome Measures
Name Time Method