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 hypertensio
- Conditions
- Essential Hypertension
- Registration Number
- EUCTR2007-001360-76-SK
- Lead Sponsor
- OVARTIS PHARMA Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1560
1. Male or female patients from 18 up to including 75 years
2. Patients with mild-to-moderate uncomplicated essential hypertension, treatment
naïve or currently taking antihypertensive therapy (monotherapy or combination
therapy of 2 drugs).
3. 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).
4. 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)
5. Written informed consent to participate in the study prior to any study procedures
6. Ability to communicate and comply with all study requirement and demonstrating
a good medication compliance (80 % compliance rate) during the run-in period.
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
For full list, please refer to protocol.
1. Severe hypertension (MSSBP =180 mmHg and/or MSDBP =110 mmHg)
2. Known or suspected contraindications, including history of allergy to ARBs,
NEPi’s or to drugs with a similar chemical structure.
3. History of angioedema, drug-related or otherwise as reported by the patient
4. History or evidence of a secondary form of hypertension, such as renal
parenchymal hypertension, renovascular hypertension, coarctation of the aorta,
primary hyperaldosteronism, Cushing’s disease, drug-induced hypertension,
unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic
kidney disease (PKD), etc.
5. Type 1 or Type 2 diabetes mellitus
6. 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 or peripheral arterial disease
7. Previous or current diagnosis of congestive heart failure NYHA Class II to IV
8. Second or third degree heart block without a pacemaker
9. Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia
10. Clinically significant valvular heart disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method