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

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT01035255

Purpose

The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =< 35%).

Condition	Intervention	Phase
Heart Failure With Reduced Ejection Fraction	Drug: LCZ696 200 mg BID Drug: Enalapril 10 mg BID	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality in Patients With Chronic Heart Failure and Reduced Ejection Fraction

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Enalapril Enalapril maleate Enalaprilat

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Time to first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization [ Time Frame: up to 4yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in the clinical summary score for HF symptoms and physical limitations (as assessed by KCCQ). [ Time Frame: up to 4yrs ] [ Designated as safety issue: No ]
Time to all-cause mortality [ Time Frame: up to 4yrs ] [ Designated as safety issue: Yes ]
Time to occurrence of renal dysfunction [ Time Frame: up to 4yrs ] [ Designated as safety issue: No ]

Estimated Enrollment:	7980
Study Start Date:	December 2009
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LCZ696 200 mg BID LCZ696 200mg BID	Drug: LCZ696 200 mg BID LCZ696 200 mg BID
Active Comparator: Enalapril 10 mg BID Enalapril 10 mg BID	Drug: Enalapril 10 mg BID Enalapril 10 mg BID

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01035255

Contacts

Contact: Novartis Pharmaceuticals

862-778-8300

Show 47 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01035255 History of Changes
Other Study ID Numbers:	CLCZ696B2314
Study First Received:	December 16, 2009
Last Updated:	July 20, 2011
Health Authority:	Argentina: National Administration of Drugs, Foods and Medical Technology; Belgium: Federal Agency for Medicines and Health Products; Brazil: Ministry of Health; Bulgaria: Ministry of Health; Canada: Health Canada; Chile: Comisión Nacional de Investigación Científica y Tecnológica; China: State Food and Drug Administration; Colombia: National Institute of Food and Drug Vigilance; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; Ecuador: Public Health Ministry; Estonia: The State Agency of Medicine; Finland: Finnish Medicines Agency; France: Sanitary Safety of Health Products Agency; Germany: Federal Institute for Drugs and Medical Devices; Guatemala: Ministry of health; Hong Kong: Department of Health; Hungary: National Institute of Pharmacy; Iceland: Icelandic Medicines Control Agency; India: Central Drug Standard Organization; Israel: Ministry of Health; Italy: National Institute of Health; Korea: Korea Food and Drug Administration; Latvia: State Agency of Medicines; Lithuania: State Medicines Control Agency; Malaysia: Ministry of Health; Mexico: Ministry of Health; Netherlands: Medicines Evaluation Board; Panama: Ministry of Health; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; Philippines: Bureau of Food and Drugs; Poland: Ministry of Health; Portugal: National Institute of Pharmacy and Medicines; Romania: National Medicines Agency; Russia: Pharmacological Committee, Ministry of Health; Singapore: Center for Drug Administration; Slovakia: State Institute for Drug Control; South Africa: Medicines Control Council; Spain: Spanish Drug Agency; Sweden: Medical Products Agency; Taiwan: Department of Health; Thailand: Ministry of Public Health; Turkey: General Directorate of Pharmaceuticals and Pharmacy; United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Venezuela: Ministry of Health and Social Development

Keywords provided by Novartis:

chronic heart failure
cardiovascular death
hospitalization
outcome study

BNP
KCCQ
eGFR

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases
Enalapril
Enalaprilat
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012