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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00742508

Purpose

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

Condition	Intervention	Phase
Chronic Heart Failure	Drug: Carvedilol-IR 2.5mg tablet Drug: SK&F-105517-D 10mg capsule Drug: SK&F-105517-D 40mg capsule Drug: SK&F-105517-D 20mg capsule Drug: Carvedilol-IR 10mg tablet	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety Study
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) -

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Carvedilol Carvedilol phosphate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Incidence of adverse events [ Time Frame: 8 weeks ]
Changes in clinical laboratory values, vital signs, body weight, 12-lead ECG and CTR [ Time Frame: 8 weeks ]

Secondary Outcome Measures:

Pharmacokinetic parameters of R-carvedilol, S-carvedilol and M4 active metabolite [ Time Frame: 8 weeks ]
24-hour blood pressure profile [ Time Frame: 8 weeks ]
Changes in 24-hour heart rate [ Time Frame: 8 weeks ]
Changes in NYHA functional class, BNP concentration and LVEF [ Time Frame: 8 weeks ]

Enrollment:	41
Study Start Date:	August 2008
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Carvedilol-IR group Carvedilol-IR 5-20mg/day	Drug: Carvedilol-IR 2.5mg tablet 1 or 2 tablet(s) twice a day Drug: Carvedilol-IR 10mg tablet 1 tablet twice a day
SK&F-105517-D group: Experimental SK&F-105517-D 10-80mg/day	Drug: SK&F-105517-D 10mg capsule 1 capsule once a day Drug: SK&F-105517-D 40mg capsule 1 or 2 capsule(s) once a day Drug: SK&F-105517-D 20mg capsule 1 capsule once a day

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 2 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742508

Locations

Japan
GSK Investigational Site
Shizuoka, Japan, 410-2295
GSK Investigational Site
Tokyo, Japan, 196-0003
GSK Investigational Site
Saitama, Japan, 364-8501
GSK Investigational Site
Ehime, Japan, 794-0006
GSK Investigational Site
Wakayama, Japan, 640-8158
GSK Investigational Site
Shizuoka, Japan, 411-8611
GSK Investigational Site
Saga, Japan, 843-0393
GSK Investigational Site
Kanagawa, Japan, 238-8558
GSK Investigational Site
Tokyo, Japan, 141-0001
GSK Investigational Site
Shizuoka, Japan, 427-8502
GSK Investigational Site
Nagasaki, Japan, 859-3615
GSK Investigational Site
Hokkaido, Japan, 060-0033
GSK Investigational Site
Shizuoka, Japan, 430-8502
GSK Investigational Site
Osaka, Japan, 565-8565
GSK Investigational Site
Tokyo, Japan, 142-8666
GSK Investigational Site
Chiba, Japan, 296-8602
GSK Investigational Site
Nagano, Japan, 397-8555
GSK Investigational Site
Mie, Japan, 511-0068
GSK Investigational Site
Hokkaido, Japan, 063-0005
GSK Investigational Site
Tokyo, Japan, 153-8515
GSK Investigational Site
Kanagawa, Japan, 210-0852
GSK Investigational Site
Hiroshima, Japan, 737-0023
GSK Investigational Site
Oita, Japan, 879-5593

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	CRV110734
Study First Received:	August 26, 2008
Last Updated:	November 25, 2009
ClinicalTrials.gov Identifier:	NCT00742508 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:

SK&F-105517-D
carvedilol phosphate
ß-blocker
Chronic heart failure(CHF)

Additional relevant MeSH terms:

Vasodilator Agents
Heart Failure
Neurotransmitter Agents
Heart Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-Antagonists

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Carvedilol

ClinicalTrials.gov processed this record on February 08, 2010