Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbidity-mortality in Patients With Chronic Heart Failure
- Registration Number
- NCT00853658
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7064
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combination Aliskiren / Enalapril Enalapril Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally. Combination Aliskiren / Enalapril Aliskiren Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally. Aliskiren Aliskiren Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally. Enalapril Enalapril Enalapril monotherapy -10 mg film-coated tablet and administered orally.
- Primary Outcome Measures
Name Time Method Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization up to End of Study (78 months) Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score Baseline, Month 12 Change from baseline to Month 12 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.
All Cause Death up to end of study (78 months) Number of patients - All-cause death. All-cause death is common in Heart Failure HF patients this measures how many patients had this event.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇻🇪Maracaibo, Estado Zulia, Venezuela