Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01876368

CLCZ696A2318

2013-001783-36 (EudraCT Number)

Details and patient eligibility

About

This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in essential hypertensive patients not adequately responsive to olmesartan

Enrollment: 376 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 drugs within 4 weeks prior to first visit) must have an office msSBP ≥ 145 mmHg and < 180 mmHg after washout epoch and after 4 weeks run-in epoch
• untreated patients (either newly diagnosed or those patients with a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to first visit) must have an offcie msSBP ≥ 150 mmHg and < 180 mmHg at screening and 1 week after screening and must have an office msSBP ≥ 145 mmHg and < 180 mmHg after 4 weeks run-in epoch
• patients must successfully complete ABPM and pass technical requirements to be qualified for randomization

Exclusion criteria

• Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
• History of angioedema, drug-related or otherwise
• 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 (PKD), drug-induced hypertension
• Patients who previously entered a LCZ696 study and had been randomized or enrolled to receive active drug treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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376 participants in 2 patient groups

LCZ696 200 mg

Experimental group

Description:

Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.

Treatment:

Drug: Placebo of LCZ696

Drug: LCZ696

Olmesartan 20 mg

Active Comparator group

Description:

Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.

Treatment:

Drug: Placebo of Olmesartan

Drug: Olmesartan