Evaluation of the Metabolic Effects of LCZ696 and Amlodipine in Obese Hypertensive Subjects

Novartis

Status and phase

Completed

Phase 2

Conditions

Hypertension

Concurrent Obesity

Treatments

Drug: Placebo

Drug: amlodipine

Drug: LCZ696

Study type

Interventional

Funder types

Industry

Identifiers

2012-002606-40 (EudraCT Number)

CLCZ696B2207

Details and patient eligibility

About

This study investigated the effects of LCZ696 on insulin sensitivity, lipolysis, and oxidative metabolism in obese hypertensive subjects.

Enrollment

98 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Written informed consent must be obtained before any study assessment is performed.
Males and females of non-childbearing potential ≥ 18 years of age.
Subjects with mild to moderate essential hypertension,
- Untreated subjects must have a mean seated SBP (msSBP) ≥ 130 mmHg and < 180 mmHg at screening.
- Pre-treated subjects must have a msSBP ≤ 160 mmHg at screening and < 180 mmHg at the end of the washout period.
Waist circumference ≥ 102 cm (men) and ≥ 88 cm (women);

Exclusion criteria

Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations.
History of angioedema, drug-related or otherwise
History of hypersensitivity to LCZ696, amlodipine, or drugs of similar chemical classes.
Severe hypertension (grade 3 of WHO classification; msDBP ≥100 mmHg and/or msSBP ≥ 180 mmHg) at screening or at the end of the washout period.
Type 1 or Type 2 diabetes mellitus.
Dyslipidemia requiring pharmacological therapy with a fibrate or nicotinic acid.
Concomitant use of anti-hypertensives, anti-diabetics, or drugs with effects on glucose or lipid metabolism for the duration of the study.

Other protocol defined inclusion/exclusion criteria may apply