Efficacy and Safety of LCZ696A in Patients With Essential Hypertension

Novartis

Status and phase

Completed

Phase 2

Conditions

Hypertension

Treatments

Drug: Placebo

Drug: AHU377

Drug: Valsartan

Drug: LCZ696

Study type

Interventional

Funder types

Industry

Identifiers

NCT00549770

CLCZ696A2201

Details and patient eligibility

About

This study was a dose-ranging efficiacy study in patients with essential hypertension to assess the blood pressure lowering effect, and safety of LCZ696 compared to valsartan and placebo. The study will also evaluate the efficacy and safety of AHU377 as compared to placebo.

Enrollment

1,334 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or females from 18 up to and including 75 years
Patients with mild-to-moderate uncomplicated essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy of 2 drugs; therapy with a fixed dose combination of two active substances represents 2 drugs)
Untreated patients must have had an office msDBP≥ 95 mmHg at the randomization visit (Visit 3) and the 2 preceding visits (Visits 1 and 2).
Treated patients must have had an office msDBP≥ 90 mmHG after washout (Visit 2), and a msDBP> 95 mmHg at baseline (Visit 3);

Exclusion criteria

Severe hypertension (msSBP ≥180 mmHg and/or msDBP ≥110 mmHg)
History of angioedema, drug-related or otherwise, as reported by the patient
Type 1 or Type 2 diabetes mellitus (according to the ADA criteria)
History or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease, etc.
History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral intervention), stroke, TIA (transient ischemic attack), carotid artery stenosis, aortic aneurysm or peripheral arterial disease

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,334 participants in 8 patient groups, including a placebo group

LCZ696 100 mg

Experimental group

Description:

Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

Treatment:

Drug: LCZ696

Drug: Placebo

LCZ696 200 mg

Experimental group

Description:

Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

Treatment:

Drug: LCZ696

Drug: Placebo

LCZ696 400 mg

Experimental group

Description:

Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

Treatment:

Drug: LCZ696

Drug: Placebo

Valsartan 80 mg

Active Comparator group

Description:

Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

Treatment:

Drug: Valsartan

Drug: Placebo

Valsartan 160 mg

Active Comparator group

Description:

Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsatan and AHU377 (5 tablets and 2 capsules) daily.

Treatment:

Drug: Valsartan

Drug: Placebo

Valsartan 320 mg

Active Comparator group

Description:

Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

Treatment:

Drug: Valsartan

Drug: Placebo

AHU377 200 mg

Experimental group

Description:

Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.

Treatment:

Drug: AHU377

Drug: Placebo

Placebo

Placebo Comparator group