Status:
COMPLETED
A Phase I/II Clinical Study of SK&F-105517-D in Japanese Patients With Chronic Heart Failure
Lead Sponsor:
GlaxoSmithKline
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 28 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2009
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00742508
Start Date
August 28 2008
End Date
August 21 2009
Last Update
August 2 2017
Active Locations (23)
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1
GSK Investigational Site
Chiba, Japan, 296-8602
2
GSK Investigational Site
Ehime, Japan, 794-0006
3
GSK Investigational Site
Hiroshima, Japan, 737-0023
4
GSK Investigational Site
Hokkaido, Japan, 060-0033