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

Novartis

Status and phase: Completed; Phase 3

Conditions: Essential Hypertension

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01599104

CLCZ696A1306

Details and patient eligibility

About

This study assessed the efficacy of LCZ696 in Japanese patients with essential hypertension

Enrollment: 1,161 patients

Sex: All

Ages: 20+ 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 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;

Exclusion criteria

• 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: Quadruple Blind

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1,161 participants in 3 patient groups

LCZ696 200 mg

Experimental group

Description:

LCZ696 200 mg tablet and placebo to both LCZ696 (1 tablet) and Olmesartan (1 capsule) tablet once daily for 8 weeks

Treatment:

Drug: Placebo

Drug: LCZ696

LCZ696 400 mg

Experimental group

Description:

LCZ696 200 mg tablet and a placebo to both LCZ696 (1 tablet) and Olmesartan (1 capsule) once daily for one week; then up-titrated to LCZ696 400 mg and placebo to Olmesartan (1 capsule) once daily for the remaining 7 weeks

Treatment:

Drug: Placebo

Drug: LCZ696

Olmesartan 20 mg

Active Comparator group

Description:

Olmesartan 20 mg capsule and placebo to LCZ696 (2 tablets) once daily for 8 weeks

Treatment:

Drug: Placebo

Drug: Olmesartan