A multi-center, randomized, double-blind, placebo and active controlled, parallel group, dose range study to evaluate the efficacy and safety of LCZ696 comparatively to valsartan, and to evaluate AHU377 to placebo after 8 week treatment in patients with essential hypertension - ND

• Conditions: essential hypertension; MedDRA version: 9.1Level: SOCClassification code 10047065Term: Vascular disorders

• Registration Number: EUCTR2007-001360-76-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1320

Inclusion Criteria

Male or female patients from 18 up to including 75 years Patients with mild-to-moderate uncomplicated essential hypertension, treatment naïve or currently taking antihypertensive therapy (monotherapy or combination therapy of 2 drugs). Treatment naïve patients must have an office mean sitting diastolic blood pressure (MSDBP) ≥ 95 mmHg and < 110 mmHg at the randomization visit (visit 3) and the 2 preceding visits (Visits 1 and 2). Pretreated patients must have an office MSDBP ³ 90 mmHg and < 110 mmHg after washout (Visit 2), and a MSDBP ³ 95 mmHg and < 110 mmHg at baseline (Visit 3) Written informed consent to participate in the study prior to any study procedures
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

Severe hypertension (MSSBP ≥180 mmHg and/or MSDBP ≥110 mmHg) Known or suspected contraindications, including history of allergy to ARBs, NEPi?s or to drugs with a similar chemical structure. History of angioedema, drug-related or otherwise as reported by the patient Type 1 or Type 2 diabetes mellitus History of angina perctoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneaous arterial intervention of any kind (coronary, carotid or peripheral intervention), stroke, TIA (transient ischemic attack), carotid artery stenosis, aortic aneurysm or peripheral arterial disease Women of child-bearing potential (WOCBP) unless they are post-menopausal or use predefined acceptable methods of contraception

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified