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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01035255
Other study ID # CLCZ696B2314
Secondary ID 2009-015834-31
Status Completed
Phase Phase 3
First received December 16, 2009
Last updated September 9, 2015
Start date December 2009
Est. completion date May 2014

Study information

Verified date September 2015
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationArgentina: National Administration of Drugs, Foods and Medical TechnologyBelgium: Federal Agency for Medicines and Health Products, FAMHPBrazil: Ministry of HealthBulgaria: Ministry of HealthCanada: Health CanadaChile: Comisión Nacional de Investigación Científica y TecnológicaChina: Food and Drug AdministrationColombia: National Institute of Food and Drug VigilanceCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyEcuador: Public Health MinistryEstonia: The State Agency of MedicineFinland: Finnish Medicines AgencyFrance: Sanitary Safety of Health Products AgencyGermany: Federal Institute for Drugs and Medical DevicesGuatemala: Ministry of healthHong Kong: Department of HealthHungary: National Institute of PharmacyIceland: Icelandic Medicines Control AgencyIndia: Central Drug Standard OrganizationIsrael: Ministry of HealthItaly: National Institute of HealthKorea: Korea Food and Drug AdministrationLatvia: State Agency of MedicinesLithuania: State Medicines Control AgencyMalaysia: Ministry of HealthMexico: Ministry of HealthNetherlands: Medicines Evaluation BoardPanama: Ministry of HealthPeru: General Directorate of Pharmaceuticals, Devices, and DrugsPhilippines: Bureau of Food and DrugsPoland: Ministry of HealthPortugal: National Institute of Pharmacy and MedicinesRomania: National Medicines AgencyRussia: Pharmacological Committee, Ministry of HealthSingapore: Center for Drug AdministrationSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilSpain: Spanish Drug AgencySweden: Medical Products AgencyTaiwan: Department of HealthThailand: Ministry of Public HealthTurkey: General Directorate of Pharmaceuticals and PharmacyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyVenezuela: Ministry of Health and Social DevelopmentArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBelgium: Federal Agency for Medicinal Products and Health ProductsColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Guatemala: Ministry of Public Health and Social AssistanceIndia: Central Drugs Standard Control OrganizationKorea: Food and Drug AdministrationLithuania: State Medicine Control Agency - Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)Portugal: National Pharmacy and Medicines InstituteSpain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial Summary

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%).


Recruitment information / eligibility

Status Completed
Enrollment 8442
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 ß-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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
LCZ696 200 mg BID
LCZ696 200 mg BID
Enalapril 10 mg BID
Enalapril 10 mg BID

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* Note: There are 1030 locations in all - only the first 1000 are shown.

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF. up to 51 months No
Secondary Number of Patients - All-cause Mortality Number of patients - All-cause mortality. All-cause mortality is common in Heart Failure HF patients this measures how many patients had this event. The data is on FAS population up to March 31, 2014 up to 51 months Yes
Secondary Number of Patients Reported With Adjudicated Primary Causes of Death Number of patients reported with adjudicated primary causes of death. The data is on Randomization population up to March 31, 2014 up to 51 months Yes
Secondary Change From Baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score Change from baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. Baseline, Month 8 No
Secondary Number of Patients With First Confirmed Renal Dysfunction Number of patients with first confirmed renal dysfunction up to 51 months No
Secondary Percentage of Participants With New Onset of Atrial Fibrillation (AF) Percentage of participants with New Onset of Atrial Fibrillation The new onset atrial fibrillation (AF) analysis was based on a subset of FAS: i.e., for patients without a history of AF at baseline (patients with a history of AF were excluded from this analysis). up to 51 months No
See also
  Status Clinical Trial Phase
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Completed NCT03614169 - Direct HIS-pacing as an Alternative to BiV-pacing in Symptomatic HFrEF Patients With True LBBB N/A
Recruiting NCT05278962 - HF Patients With LVADs Being Treated With SGLT2i Phase 4
Completed NCT04210375 - Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) Phase 1
Not yet recruiting NCT06433687 - Evaluation of the HekaHeart Platform in Medication Management for Heart Failure Patients
Completed NCT05001165 - Dashboard Activated Services and Tele-Health for Heart Failure N/A
Active, not recruiting NCT03701880 - Early Use of Ivabradine in Heart Failure N/A
Recruiting NCT05650658 - Left vs Left Randomized Clinical Trial N/A
Not yet recruiting NCT06299436 - Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure
Recruiting NCT05992116 - Iron Deficiency in Patients With Heart Failure and Reduced and Mildly Reduced Ejection Fraction
Recruiting NCT05365568 - Left Bundle Branch Area Pacing for Cardiac Resynchronization Therapy: A Randomized Study N/A
Active, not recruiting NCT05204238 - Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)
Not yet recruiting NCT04420065 - Effects of Preferential Left Ventricular Pacing on Ventriculoarterial Coupling and Clinical Course of Heart Failure N/A
Terminated NCT03479424 - Home Outpatient Monitoring and Engagement to Predict HF Exacerbation
Completed NCT02113033 - VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients Phase 2
Recruiting NCT03209180 - Immediate Release Versus Slow Release Carvedilol in Heart Failure Phase 4
Recruiting NCT05299879 - Screening for Advanced Heart Failure IN Stable ouTpatientS - The SAINTS Study
Recruiting NCT05637853 - Telemonitored Fast Track Medical Sequencing for Heart Failure With Reduced Ejection Fraction
Completed NCT03870074 - CPET Predicts Long-term Survival and Positive Response to CRT
Recruiting NCT04590001 - Effect of the MobiusHD® in Patients With Heart Failure N/A