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Extended-Release Carvedilol Sulfate vs Metoprolol Succinate in Heart Failure
NCT02012075Phase 3
Key facts
- Status
- Unknown
- Start
- Dec 2013
- Primary completion
- Feb 2015
- Countries
- 1
- Sponsor
- Hengrui
- Modality
- Small Molecules
- Drugs
- carvedilol
- Conditions
- heart failure (HF)
01
Overview
Phase 3, randomised trial of carvedilol in heart failure (HF) (2 arms), sponsored by Hengrui. Primary endpoint: Change From Baseline in left ventricular ejection fraction at Week 36. Status: unknown.
02
Design
2 arms- Study design
- Randomized
Extended-Release Carvedilol Sulfate
18-72mg/d, po
Sustained-release Metoprolol Succinate
11.875-190mg/d, po
03
Who it enrols
Patients aged 18-75 with NYHA class II-III heart failure and LVEF < 0.45, on optimal ACEi/ARB therapy. Excludes patients with recent ACS, severe valvular disease, or contraindications to beta-blockers.
04
Endpoints
Primary
Change From Baseline in left ventricular ejection fraction
Secondary
Change From Baseline in Left Ventricular End Systolic Volume Index
Change From Baseline in Left Ventricular End Diastolic Volume Index
Incidence of Hospitalizations From Exacerbation of Heart Failure
Incidence of Hospitalizations From All Causes
Incidence of Deaths From All Causes
Change From Baseline in New York Heart Association classification
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