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
- hypertension = high blood pressureincreased arterial pressure10057166
- Registration Number
- NL-OMON31167
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
For complete list, please refer to the protocol pg 17;- Male or female patients from 18 up to and including 75 years
- Patients with mild-to-moderate uncomplicated essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy of 2 drugs)
-Untreated patients must have an office MSDBP higher than or equal to 95 mmHg at the randomization visit (V3) and the 2 preceding visits (V1 and V2)
-Pretreated patients must have an office MSDBP higher than or equal to 90 mmHg after washout (V2), and a MSDBP higher than or equal to 95 mmHg at baseline (V3)
For complete list, please refer to protocol pg 17/18;-Severe hypertension (MSSBP equal to or higher than 180 mmHg and/or MSDBP equal to or higher than 110 mmHG)
- Known or suspected contraindications, including history of allergy to ARBs, NEPis or to drugs with a similar chemical structure
- History of angiodema, drug-related or otherwise, as reported by the patient
-Type 1 or Type 2 diabetes mellitus (according to the ADA criteria)
- 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.
- History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral intervention), stroke, TIA, carotid artery stenosis, aortic aneurysm or peripheral arterial disease
- Women of child-bearing potential, unless they are post-menopausal or use predefined acceptable methods of contraception
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change in MSDBP (mean sitting diastolic blood pressure) at trough from baseline<br /><br>(visit 3) to the endpoint visit. For definitions of MSDP and endpoint visit,<br /><br>please refer to protocol pg 50, paragraph 10.4.1.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Changes in MSDBP and MSSBP at trough from baseline for each dose of studied<br /><br>drug<br /><br><br /><br>- Successful responder rate in MSDBP (< 90 mmHg or a reduction of at least 10<br /><br>mmHg from baseline) and successful control rate in MSDBP (<90 mmHg) at wk 8;<br /><br>successful responder rate in MSSBP (<140 mmHg or a reduction of at least 20mmHg<br /><br>from baseline) and successful control rate in MSSBP (<140 mmHg) at wk 8;<br /><br>successful control rate in both MSSBP (<140 mmHg) and MSDBP (<90 mmHg) at wk 8<br /><br><br /><br>- Changes in 24-hour, daytime and nighttime ambulatory diastolic and systolic<br /><br>blood pressure from baseline to wk 8. </p><br>