NCT01631864

Brief Summary

This study investigated the effects of LCZ696 on insulin sensitivity, lipolysis, and oxidative metabolism in obese hypertensive subjects.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for phase_2 hypertension

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_2 hypertension

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

August 10, 2015

Completed
Last Updated

August 10, 2015

Status Verified

June 1, 2015

Enrollment Period

9 months

First QC Date

June 27, 2012

Results QC Date

July 11, 2015

Last Update Submit

July 11, 2015

Conditions

HypertensionConcurrent Obesity

Keywords

Hypertension, obesity, insulin sensitivity, lipolysis, LCZ696

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Insulin Sensitivity Index

    The insulin sensitivity index was assessed by hyperinsulinemic euglycemic clamp (HEGC). A positive change from baseline indicates improvement.

    baseline, 8 weeks

Secondary Outcomes (3)

  • Local Adipose Tissue Lipolysis, Glycerol Concentrations

    57 days

  • Oxidative Metabolism

    57 days

  • Number of Participants With Adverse Events, Serious Adverse Events and Deaths

    8 weeks

Study Arms (2)

LCZ696

EXPERIMENTAL

LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks

Drug: LCZ696Drug: Placebo

amlodipine

ACTIVE COMPARATOR

amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks

Drug: amlodipineDrug: Placebo

Interventions

LCZ696DRUG

LCZ696 was provided as 400 mg tablets.

LCZ696
amlodipineDRUG

amlodipine was provided as 5 mg tablets.

amlodipine
PlaceboDRUG

Matching placebo to LCZ696 and amlodipine.

LCZ696amlodipine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Neuss, 41460, Germany

Location

Novartis Investigative Site

Maastricht, 5800, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 29180454DERIVED

MeSH Terms

Conditions

HypertensionObesityInsulin Resistance

Interventions

sacubitril and valsartan sodium hydrate drug combinationAmlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2012

First Posted

June 29, 2012

Study Start

October 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

August 10, 2015

Results First Posted

August 10, 2015

Record last verified: 2015-06

Locations

NL(1)DE(2)