A Phase I/II Clinical Study of SK&F-105517-D in Japanese Patients With Chronic Heart Failure

• Status: Completed
• Trial end date: 2009-08-21
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the safety and tolerability of SK&F-105517-D in japanese patients with chronic heart failure.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Carvedilol

Criteria

Inclusion criteria:

• Patients with symptomatically stable chronic heart failure (CHF) based on ischemic heart disease or dilated cardiomyopathy

• Patients who are maintained on basic heart failure therapy with angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blocker (ARB) and their dosage/administration is not changed within 2 weeks

• Patients diagnosed with New York Heart Association (NYHA) class I to III

• Patients with a left ventricular ejection fraction (LVEF) between 25% and 45%

Exclusion Criteria:

• Patients contraindicated for ß-blockers

• Patients with occurrence of acute myocardial infarction within 2 weeks

• Patients with unstable angina, coronary spastic angina, or angina at rest

• Patients who have collected blood >400 mL within 4 months prior to screening or >200 mL within 1 months