Double-blind Study of Treatment with LCZ696 in Japanese Patients with Essential Hypertensio
- Conditions
- Essential Hypertension
- Registration Number
- JPRN-jRCT2080221840
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 1629
Patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy.
-Treated patients (using antihypertensive treatments within 4 weeks prior to Visit 1) must have an msSBP >= 150 mmHg and < 180 mmHg at the randomization visit (Visit 201) and msSBP >= 140 mmHg < 180 mmHg at the visit immediately proceeding Visit 201 (Visit 102 or 103).
-Untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to Visit 1) must have an msSBP >= 150 mmHg and < 180 mmHg at both Visit 1 and Visit 201.
-Patients must have an absolute difference of =< 15 mmHg in msSBP between Visit 201 and the immediately preceding visit.
-Severe hypertension (msDBP >= 110 mmHg and/or msSBP >= 180 mmHg).
-History of angioedema, drug-related or otherwise, as reported by the patient.
-History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.
-Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch.
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method