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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 )

Tracking Information
First Submitted Date  ICMJE June 27, 2012
First Posted Date  ICMJE June 29, 2012
Results First Submitted Date  ICMJE July 11, 2015
Results First Posted Date  ICMJE August 10, 2015
Last Update Posted Date August 10, 2015
Study Start Date  ICMJE October 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2012)
Difference in insulin sensitivity index after treatment with LCZ696 or amlodipine [ Time Frame: After 8 weeks of treatment ]
The insulin sensitivity index will be assessed by hyperinsulinemic euglycemic clamp
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2015)
  • 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.
  • Oxidative Metabolism [ Time Frame: 57 days ]
    Oxidative metabolism was assessed by indirect calorimetry.
  • Number of Participants With Adverse Events, Serious Adverse Events and Deaths [ Time Frame: 8 weeks ]
    Adverse event monitoring was conducted throughout the study.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2012)
  • Subcutaneous adipose tissue lipolysis at rest [ Time Frame: After 8 weeks of treatment ]
    Assessment will by done by microdialysis.
  • Oxidative metabolism at rest [ Time Frame: After 8 weeks of treatment ]
    Assessment will be done by indirect calorimetry
  • Number of patients with abnormal laboratory values, vital signs, ECGs [ Time Frame: During 8 weeks of treatment ]
    Tolerability will be assessed by Physical examination, vital signs, including seria lsupine BP and pulse measurements, laboratory evaluations (hematology, blood chemistry, urinalysis), ECG, and adverse event monitoring
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Metabolic Effects of LCZ696 and Amlodipine in Obese Hypertensive Subjects
Official Title  ICMJE A Randomized, Double-blind, Parallel Group Study to Evaluate Metabolic Effects of LCZ696 and Amlodipine in Obese Hypertensive Subjects
Brief Summary This study investigated the effects of LCZ696 on insulin sensitivity, lipolysis, and oxidative metabolism in obese hypertensive subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE
  • Hypertension
  • Concurrent Obesity
Intervention  ICMJE
  • Drug: LCZ696
    LCZ696 was provided as 400 mg tablets.
  • Drug: amlodipine
    amlodipine was provided as 5 mg tablets.
  • Drug: Placebo
    Matching placebo to LCZ696 and amlodipine.
Study Arms  ICMJE
  • Experimental: LCZ696
    LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
    Interventions:
    • Drug: LCZ696
    • Drug: Placebo
  • Active Comparator: amlodipine
    amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
    Interventions:
    • Drug: amlodipine
    • Drug: Placebo
Publications * Engeli S, Stinkens R, Heise T, May M, Goossens GH, Blaak EE, Havekes B, Jax T, Albrecht D, Pal P, Tegtbur U, Haufe S, Langenickel TH, Jordan J. Effect of Sacubitril/Valsartan on Exercise-Induced Lipid Metabolism in Patients With Obesity and Hypertension. Hypertension. 2018 Jan;71(1):70-77. doi: 10.1161/HYPERTENSIONAHA.117.10224. Epub 2017 Nov 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2015)
98
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2012)
100
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01631864
Other Study ID Numbers  ICMJE CLCZ696B2207
2012-002606-40 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP