S 05985 combination versus Angiotensin II Receptor Blocker/Calcium Channel Blocker: a comparison of blood pressure lowering - efficacy and safety

• Conditions: Essential arterial hypertension; MedDRA version: 14.1Level: LLTClassification code 10020775Term: Hypertension arterialSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2010-020945-28-DE
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-05
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

- Outpatients,
- Men or women,
- 18 years old at least,
- Mild to moderate hypertensive patient (SBP<180mmHg and DBP<110mmHg)
For patients without ongoing antihypertensive treatment:
150= SBP < 180 mm Hg and 95 = DBP < 110 mm Hg.
For treated patients with no more than 2 antihypertensive drugs:
SBP <160mmHg and DBP <100mmHg.
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 1000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

Exclusion Criteria

- Pregnant or breastfeeding women,
- Patients treated with more than 2 antihypertensive drugs with perindopril/amlodipine or with valsartan/amlodipine at the highest available doses,
- Patient with history of intolerance with one or several of the study drugs, either perindopril, valsartan, amlodipine or indapamide,
- 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