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

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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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

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
Germany | |
Novartis Investigative Site | |
Hannover, Germany, 30625 | |
Novartis Investigative Site | |
Neuss, Germany, 41460 | |
Netherlands | |
Novartis Investigative Site | |
Maastricht, Netherlands, 5800 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01631864 |
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 |
Hypertension, obesity, insulin sensitivity, lipolysis, LCZ696 |
Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine LCZ 696 Antihypertensive Agents Calcium Channel Blockers |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents Angiotensin Receptor Antagonists |