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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01631864
First received: June 27, 2012
Last updated: September 24, 2013
Last verified: September 2013
History of Changes
  Purpose

This study will investigate the effects of LCZ696 on insulin sensitivity, lipolysis, and oxidative metabolism of fatty acids in obese hypertensive subjects.


Condition Intervention Phase
Hypertension
Concurrent Obesity
 Drug: LCZ696
Drug: Amlodipine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Randomized, Double-blind, Parallel Group Study to Evaluate Metabolic Effects of LCZ696 and Amlodipine in Obese Hypertensive Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Difference in insulin sensitivity index after treatment with LCZ696 or amlodipine [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
    The insulin sensitivity index will be assessed by hyperinsulinemic euglycemic clamp


Secondary Outcome Measures:
  • Subcutaneous adipose tissue lipolysis at rest [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
    Assessment will by done by microdialysis.

  • Oxidative metabolism at rest [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
    Assessment will be done by indirect calorimetry

  • Number of patients with abnormal laboratory values, vital signs, ECGs [ Time Frame: During 8 weeks of treatment ] [ Designated as safety issue: No ]
    Tolerability will be assessed by Physical examination, vital signs, including serial lupine BP and pulse measurements, laboratory evaluations (hematology, blood chemistry, urinalysis), ECG, and adverse event monitoring
Enrollment: 97
Study Start Date: October 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LCZ696
LCZ696 plus placebo to Amlodipine once daily for 8 weeks
 Drug: LCZ696
Active Comparator: Amlodipine
Amlodipine plus placebo to LCZ696 once daily for 8 weeks
 Drug: Amlodipine

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  • Women of child-bearing potential
  • Pregnant or nursing (lactating) 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01631864     History of Changes
Other Study ID Numbers: CLCZ696B2207, 2012-002606-40
Study First Received: June 27, 2012
Last Updated: September 24, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices (BfArM)
Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by Novartis:
Hypertension, obesity, glucose metabolism lipid metabolism, LCZ696, insulin sensitivity, lipolysis

Additional relevant MeSH terms:
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on March 03, 2015