Phase 2
Completed N=98
Evaluation of the Metabolic Effects of LCZ696 and Amlodipine in Obese Hypertensive Subjects
Hypertension · Concurrent Obesity
Source: ClinicalTrials.gov NCT01631864 ↗
Enrolled (actual)
98
Serious AEs
2.0%
Results posted
Aug 2015
Primary outcomePrimary: Change From Baseline in Insulin Sensitivity Index — 0.192; 0.065 ug/kg*min/(mmol/L*pmol/L)
Summary
This study investigated the effects of LCZ696 on insulin sensitivity, lipolysis, and oxidative metabolism in obese hypertensive subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Insulin Sensitivity Index |
0.192; 0.065 | — |
| SECONDARY Local Adipose Tissue Lipolysis, Glycerol Concentrations |
82.46; 65.91 | — |
| SECONDARY Oxidative Metabolism |
0.787; 0.775 | — |
| SECONDARY Number of Participants With Adverse Events, Serious Adverse Events and Deaths |
30; 37; 1; 1; 0; 0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01631864). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.