Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Asian Patients With Essential Hypertension

Launched by NOVARTIS PHARMACEUTICALS · Feb 5, 2013

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Eligibility criteria

• Inclusion Criteria:
• • 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 preceding 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.
• Exclusion Criteria:
• • Patients with 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.