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This Study Will Evaluate the ...

This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure

Last Updated: 2016-08-15

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

8442 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2014-05-31

Brief Summary

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Conditions

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Heart Failure With Reduced Ejection Fraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LCZ696

single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period

Group Type EXPERIMENTAL

LCZ696 200 mg BID

Intervention Type DRUG

LCZ696 200 mg BID

Enalapril

single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period

Group Type ACTIVE_COMPARATOR

Enalapril 10 mg BID

Intervention Type DRUG

Enalapril 10 mg BID

Interventions

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LCZ696 200 mg BID

Intervention Type DRUG

Enalapril 10 mg BID

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must give written informed consent before any assessment is performed.
* Outpatients ≥ 18 years of age, male or female.
* Patients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction (EF =\< 35%) and elevated BNP.
* Patients must be on an ACEI or an ARB at a stable dose of at least enalapril 10 mg/d or equivalent for at least 4 weeks.
* Patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks.

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.
* History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs.
* Previous history of intolerance to recommended target doses of ACEIs or ARBs
* Known history of angioedema.
* Requirement of treatment with both ACEIs and ARBs.
* Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy).
* Symptomatic hypotension and/or a SBP \< 100 mmHg.
* Estimated GFR \< 30 mL/min/1.73m2 as measured by the simplified MDRD formula
* Serum potassium \> 5.2 mmol/L.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

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United States Argentina Belgium Brazil Bulgaria Canada Chile China Colombia Czechia Denmark Dominican Republic Ecuador Estonia Finland France Germany Guatemala Hong Kong Hungary Iceland India Israel Italy Latvia Lithuania Malaysia Mexico Netherlands Panama Peru Philippines Poland Portugal Romania Russia Singapore Slovakia South Africa South Korea Spain Sweden Taiwan Thailand Turkey (Türkiye) United Kingdom Venezuela