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

A Study to Evaluate the Safety and Tolerability of SK&F-105517-D in Patients With Chronic Heart Failure- An Open-label Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of SK&F-105517-D in Patients With Chronic Heart Failure (Phase I/II Study)

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.

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