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.

• Conditions: Essential arterial hypertension; MedDRA version: 8.1Level: LLTClassification code 10020775Term: Hypertension arterial

• Registration Number: EUCTR2006-005797-44-LV
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-28
• Last Update Posted: 19 March 2012

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