This study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality of patients with chronic heartfailure

Phase 1

• Conditions: MedDRA version: 14.0Level: LLTClassification code 10008502Term: CHFSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; Chronic Heart Failure

• Registration Number: EUCTR2009-015834-31-BE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-05
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 7980

Inclusion Criteria

1. Patients must give written informed consent before any assessment is performed.
2. Outpatients = 18 years of age, male or female.
3. Patients with a diagnosis of CHF NYHA class, II-IV, reduced ejection
fraction (EF = 35%) and elevated BNP.
4. 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
5. Patients must be treated with a ß-blocker, unless contraindicated or
not tolerated, at a stable dose for at least 4 weeks
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Use of other investigational drugs at the time of enrollment, or within
30 days or 5 half-lives of enrollment, whichever is longer
2. 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
3. Previous history of intolerance to recommended target doses of ACEIs or ARBs
4. Known history of angioedema
5. Requirement of treatment with both ACEIs and ARBs
6. Current acute decompensated HF (exacerbation of chronic HF
manifested by signs and symptoms that may require intravenous
therapy)
7. Symptomatic hypotension and/or a SBP < 100 mmHg
8. Estimated GFR < 30 mL/min/1.73m2 as measured by the simplified
MDRD formula

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified