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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Heart Failure, Congestive

Treatments: Drug: SK&F-105517-D 10 mg capsule; Drug: Carvedilol-IR 10 mg tablet; Drug: SK&F-105517-D 20 mg capsule; Drug: SK&F-105517-D 40 mg capsule; Drug: Carvedilol-immediate release (IR) 2.5 mg tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00742508

CRV110734

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

SK&F-105517-D group

Experimental group

Description:

SK\&F-105517-D 10-80 mg/day

Treatment:

Drug: SK&F-105517-D 40 mg capsule

Drug: SK&F-105517-D 20 mg capsule

Drug: SK&F-105517-D 10 mg capsule

Carvedilol-IR group

Other group

Description:

Carvedilol-IR 5-20 mg/day

Treatment:

Drug: Carvedilol-IR 10 mg tablet

Drug: Carvedilol-immediate release (IR) 2.5 mg tablet