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

Novartis

Status and phase: Completed; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: Olmesartan; Drug: Placebo of LCZ696; Drug: Placebo of Olmesartan; Drug: LCZ696

Study type: Interventional

Funder types: Industry

Identifiers

NCT01785472

CLCZ696A2315 (Other Identifier)

Details and patient eligibility

About

This study will assess the efficacy and safety of multiple doses of LCZ696 compared to olmesartan in Asian patients with essential hypertension

Enrollment: 1,438 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,438 participants in 3 patient groups

LCZ696 200 mg

Experimental group

Description:

Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.

Treatment:

Drug: Placebo of Olmesartan

Drug: LCZ696

Drug: Placebo of LCZ696

LCZ696 400 mg

Experimental group

Description:

Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.

Treatment:

Drug: Placebo of Olmesartan

Drug: LCZ696

Drug: Placebo of LCZ696

Olmesartan 20 mg

Active Comparator group

Description:

Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.

Treatment:

Drug: Olmesartan

Drug: Placebo of LCZ696