A randomized, double-blind, parallel group study to evaluate metabolic effects of LCZ696 and amlodipine in obese hypertensive subjects: the CLCZ696B2207 study

Phase 2

Completed

• Conditions: Insulin sensitivity; metabolism; 10018424; 10013317

• Registration Number: NL-OMON40044
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2013-07-05
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 28

Inclusion Criteria

Obese people (>= 18 years old) with mild to moderate essential hypertension with non-childbearing potential

Exclusion Criteria

use of other medication, pregnancy, lactating women, history of angioedema, heavy hypertention (grade 3 of the WHO classification)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>insulin sensitivity (Hyperinsuline Euglycemische Glucose Clamp (HEGC) )</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundairy reseach variabilities are:<br /><br>subcutaneous adipose tissue lipolysis (assesed by microdialysis), oxidative<br /><br>metabolism (assessed by indirect calorimetry) and tolerability of the<br /><br>medication in obese hypertensive subjects.</p><br>