A study to evaluate metabolic effects of LCZ696 and amlodipine in obese hypertensive subjects

• Conditions: Mild to moderate essential hypertension in obese subjects; MedDRA version: 14.1Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-002606-40-DE
• Lead Sponsor: ovartis Pharma Service AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-20
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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).

For detailed inclusion criteria see the full protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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.
• Women of child-bearing potential.
• Pregnant or nursing (lactation) women.
• 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 drug with effects on glucose or lipid metabolism for the duration of the study.

For detailed exclusion criteria see the full protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of LCZ696 400 mg QD as compared to amlodipine 10 mg QD on insulin sensitivity after 8 weeks of treatment in obese hypertensive subjects.;Secondary Objective: • To evaluate the effect of LCZ696 and amlodipine on subcutaneous adipose tissue lipolysis at rest and the oxydative metabolism at rest <br>• To evaluate the tolerability of LCZ696 and amlodipine in obese hypertensive subjects.<br>;Primary end point(s): Difference in insulin sensitivity index after treatment with LCZ696 or amlodipine. ;Timepoint(s) of evaluation of this end point: 8 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Subcutaneous adipose tissue lipolysis at rest.<br>• Oxidative metabolism at rest.<br>• Number of patients with abnormal laboratory values, vital signs, ECGs.;Timepoint(s) of evaluation of this end point: 8 weeks