This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure (PARADIGM-HF)
This study is currently recruiting participants.
Verified April 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01035255
First received: December 16, 2009
Last updated: April 30, 2013
Last verified: April 2013
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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 3 |
| 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:
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: | April 2003 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (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
Show 1342 Study Locations
Contacts
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | |
| Contact: Novartis Pharmaceuticals |
Show 1342 Study LocationsSponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01035255 History of Changes |
| Other Study ID Numbers: | CLCZ696B2314, 2009-015834-31 |
| Study First Received: | December 16, 2009 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Food and Drug Administration Argentina: National Administration of Drugs, Foods and Medical Technology Belgium: Federal Agency for Medicines and Health Products, FAMHP Brazil: Ministry of Health Bulgaria: Ministry of Health Canada: Health Canada Chile: Comisión Nacional de Investigación Científica y Tecnológica China: 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 Kingdom: Medicines and Healthcare Products Regulatory Agency Venezuela: Ministry of Health and Social Development Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Belgium: Federal Agency for Medicinal Products and Health Products Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Guatemala: Ministry of Public Health and Social Assistance India: Central Drugs Standard Control Organization Korea: Food and Drug Administration Lithuania: State Medicine Control Agency - Ministry of Health Netherlands: Medicines Evaluation Board (MEB) Portugal: National Pharmacy and Medicines Institute Spain: Spanish Agency of Medicines |
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 June 17, 2013