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

June 27, 2012
September 24, 2013
October 2012
July 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01631864 on ClinicalTrials.gov Archive Site
  • 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
  • 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 seria lsupine BP and pulse measurements, laboratory evaluations (hematology, blood chemistry, urinalysis), ECG, and adverse event monitoring
Not Provided
Not Provided
 
Evaluation of the Metabolic Effects of LCZ696 and Amlodipine in Obese Hypertensive Subjects
A Randomized, Double-blind, Parallel Group Study to Evaluate Metabolic Effects of LCZ696 and Amlodipine in Obese Hypertensive Subjects

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Hypertension
  • Concurrent Obesity
  • Drug: LCZ696
  • Drug: Amlodipine
  • Experimental: LCZ696
    LCZ696 plus placebo to Amlodipine once daily for 8 weeks
    Intervention: Drug: LCZ696
  • Active Comparator: Amlodipine
    Amlodipine plus placebo to LCZ696 once daily for 8 weeks
    Intervention: Drug: Amlodipine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
July 2013
July 2013   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Netherlands
 
NCT01631864
CLCZ696B2207, 2012-002606-40
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2013

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