A Phase I/II Clinical Study of SK&F-105517-D in Patients With Chronic Heart Failure
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Heart Failure
Intervention: carvedilol phosphate (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718
Summary
A Phase I/II study to evaluate the safety and tolerability, pharmacokinetics and
pharmacodynamics of SK&F-105517-D in patients with chronic heart failure
Clinical Details
Official title: 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) -
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety Study
Primary outcome: Incidence of adverse eventsChanges in clinical laboratory values, vital signs, body weight, 12-lead ECG and CTR
Secondary outcome: Pharmacokinetic parameters of R-carvedilol, S-carvedilol and M4 active metabolite24-hour blood pressure profile Changes in 24-hour heart rate Changes in NYHA functional class, BNP concentration and LVEF
Eligibility
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
- Patients with symptomatically stable CHF based on ischemic heart disease or dilated
cardiomyopathy
- Patients who are maintained on basic heart failure therapy with ACE inhibitors or ARB
and their dosage/administration is not changed within 8 weeks
- Patients diagnosed with NYHA class I to III
- Patients with a 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
Locations and Contacts
US GSK Clinical Trials Call Center, Phone: 877-379-3718
GSK Investigational Site, Chiba 296-8602, Japan; Recruiting
GSK Investigational Site, Hokkaido 063-0005, Japan; Recruiting
GSK Investigational Site, Wakayama 640-8158, Japan; Recruiting
GSK Investigational Site, Shizuoka 411-8611, Japan; Not yet recruiting
GSK Investigational Site, Tokyo 153-8515, Japan; Recruiting
GSK Investigational Site, Hiroshima 737-0023, Japan; Recruiting
GSK Investigational Site, Nagano 397-8555, Japan; Recruiting
GSK Investigational Site, Mie 511-0068, Japan; Recruiting
GSK Investigational Site, Hokkaido 060-0033, Japan; Recruiting
GSK Investigational Site, Kanagawa 238-8558, Japan; Completed
GSK Investigational Site, Tokyo 141-0001, Japan; Completed
GSK Investigational Site, Shizuoka 427-8502, Japan; Completed
GSK Investigational Site, Nagasaki 859-3615, Japan; Completed
GSK Investigational Site, Kanagawa 210-0852, Japan; Active, not recruiting
GSK Investigational Site, Oita 879-5593, Japan; Completed
GSK Investigational Site, Shizuoka 410-2295, Japan; Active, not recruiting
GSK Investigational Site, Saga 843-0391, Japan; Active, not recruiting
GSK Investigational Site, Shizuoka 430-8502, Japan; Completed
GSK Investigational Site, Tokyo 196-0003, Japan; Active, not recruiting
GSK Investigational Site, Osaka 565-8565, Japan; Completed
GSK Investigational Site, Tokyo 142-8666, Japan; Completed
GSK Investigational Site, Saitama 364-8501, Japan; Active, not recruiting
GSK Investigational Site, Ehime 794-0006, Japan; Active, not recruiting
Additional Information
Starting date: August 2008
Ending date: September 2009
Last updated: June 12, 2009
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