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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Hypertension Concurrent Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LCZ696

LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks

Group Type EXPERIMENTAL

LCZ696

Intervention Type DRUG

LCZ696 was provided as 400 mg tablets.

Placebo

Intervention Type DRUG

Matching placebo to LCZ696 and amlodipine.

amlodipine

amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks

Group Type ACTIVE_COMPARATOR

amlodipine

Intervention Type DRUG

amlodipine was provided as 5 mg tablets.

Placebo

Intervention Type DRUG

Matching placebo to LCZ696 and amlodipine.

Interventions

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LCZ696

LCZ696 was provided as 400 mg tablets.

Intervention Type DRUG

amlodipine

amlodipine was provided as 5 mg tablets.

Intervention Type DRUG

Placebo

Matching placebo to LCZ696 and amlodipine.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No