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

Hypertension Clinical Trial

Official title:

A Randomized, Double-blind, Parallel Group Study to Evaluate Metabolic Effects of LCZ696 and Amlodipine in Obese Hypertensive Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631864
• Other study ID #: CLCZ696B2207
• Secondary ID: 2012-002606-40
• Status: Completed
• Phase: Phase 2
• First received: June 27, 2012
• Last updated: July 11, 2015
• Start date: October 2012
• Est. completion date: July 2013

Study information

• Verified date: June 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices (BfArM)Netherlands: Medicines Evaluation Board (MEB)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Concurrent Obesity
• Hypertension

Intervention

Drug:
• LCZ696
LCZ696 was provided as 400 mg tablets.
• amlodipine
amlodipine was provided as 5 mg tablets.
• Placebo
Matching placebo to LCZ696 and amlodipine.

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Neuss
Netherlands	Novartis Investigative Site	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Insulin Sensitivity Index	The insulin sensitivity index was assessed by hyperinsulinemic euglycemic clamp (HEGC). A positive change from baseline indicates improvement.	baseline, 8 weeks	No
Secondary	Local Adipose Tissue Lipolysis, Glycerol Concentrations	Lipolysis was assessed through subcutaneous adipose tissue microdialysis. The actual measure type is adjusted geometric mean.	57 days	No
Secondary	Oxidative Metabolism	Oxidative metabolism was assessed by indirect calorimetry.	57 days	No
Secondary	Number of Participants With Adverse Events, Serious Adverse Events and Deaths	Adverse event monitoring was conducted throughout the study.	8 weeks	Yes