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

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ClinicalTrials.gov Identifier: NCT01631864
Recruitment Status : Completed
First Posted : June 29, 2012
Results First Posted : August 10, 2015
Last Update Posted : August 10, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Hypertension Concurrent Obesity Drug: LCZ696 Drug: amlodipine Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Randomized, Double-blind, Parallel Group Study to Evaluate Metabolic Effects of LCZ696 and Amlodipine in Obese Hypertensive Subjects
Study Start Date : October 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: LCZ696
LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
 Drug: LCZ696
LCZ696 was provided as 400 mg tablets.
Drug: Placebo
Matching placebo to LCZ696 and amlodipine.
Active Comparator: amlodipine
amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
 Drug: amlodipine
amlodipine was provided as 5 mg tablets.
Drug: Placebo
Matching placebo to LCZ696 and amlodipine.


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Insulin Sensitivity Index [ Time Frame: baseline, 8 weeks ]
    The insulin sensitivity index was assessed by hyperinsulinemic euglycemic clamp (HEGC). A positive change from baseline indicates improvement.


Secondary Outcome Measures :
  1. Local Adipose Tissue Lipolysis, Glycerol Concentrations [ Time Frame: 57 days ]
    Lipolysis was assessed through subcutaneous adipose tissue microdialysis. The actual measure type is adjusted geometric mean.

  2. Oxidative Metabolism [ Time Frame: 57 days ]
    Oxidative metabolism was assessed by indirect calorimetry.

  3. Number of Participants With Adverse Events, Serious Adverse Events and Deaths [ Time Frame: 8 weeks ]
    Adverse event monitoring was conducted throughout the study.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631864


Locations
Germany
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Neuss, Germany, 41460
Netherlands
Novartis Investigative Site
Maastricht, Netherlands, 5800
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01631864     History of Changes
Other Study ID Numbers: CLCZ696B2207
2012-002606-40 ( EudraCT Number )
First Posted: June 29, 2012    Key Record Dates
Results First Posted: August 10, 2015
Last Update Posted: August 10, 2015
Last Verified: June 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Hypertension, obesity, insulin sensitivity, lipolysis, LCZ696

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
LCZ 696
Antihypertensive Agents
 Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin Receptor Antagonists