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

NCT ID: NCT00742508

Last Updated: 2017-08-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-28

Study Completion Date

2009-08-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure, Congestive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SK&F-105517-D group

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

Group Type EXPERIMENTAL

SK&F-105517-D 10 mg capsule

Intervention Type DRUG

1 capsule once a day

SK&F-105517-D 20 mg capsule

Intervention Type DRUG

1 capsule once a day

SK&F-105517-D 40 mg capsule

Intervention Type DRUG

1 or 2 capsule(s) once a day

Carvedilol-IR group

Carvedilol-IR 5-20 mg/day

Group Type OTHER

Carvedilol-immediate release (IR) 2.5 mg tablet

Intervention Type DRUG

1 or 2 tablet(s) twice a day

Carvedilol-IR 10 mg tablet

Intervention Type DRUG

1 tablet twice a day

Interventions

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SK&F-105517-D 10 mg capsule

1 capsule once a day

Intervention Type DRUG

Carvedilol-immediate release (IR) 2.5 mg tablet

1 or 2 tablet(s) twice a day

Intervention Type DRUG

SK&F-105517-D 20 mg capsule

1 capsule once a day

Intervention Type DRUG

SK&F-105517-D 40 mg capsule

1 or 2 capsule(s) once a day

Intervention Type DRUG

Carvedilol-IR 10 mg tablet

1 tablet twice a day

Intervention Type DRUG

Other Intervention Names

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carvedilol phosphate carvedilol phosphate carvedilol phosphate

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Chiba, , Japan

Site Status

GSK Investigational Site

Ehime, , Japan

Site Status

GSK Investigational Site

Hiroshima, , Japan

Site Status

GSK Investigational Site

Hokkaido, , Japan

Site Status

GSK Investigational Site

Hokkaido, , Japan

Site Status

GSK Investigational Site

Kanagawa, , Japan

Site Status

GSK Investigational Site

Kanagawa, , Japan

Site Status

GSK Investigational Site

Mie, , Japan

Site Status

GSK Investigational Site

Nagano, , Japan

Site Status

GSK Investigational Site

Nagasaki, , Japan

Site Status

GSK Investigational Site

Osaka, , Japan

Site Status

GSK Investigational Site

Ōita, , Japan

Site Status

GSK Investigational Site

Saga, , Japan

Site Status

GSK Investigational Site

Saitama, , Japan

Site Status

GSK Investigational Site

Shizuoka, , Japan

Site Status

GSK Investigational Site

Shizuoka, , Japan

Site Status

GSK Investigational Site

Shizuoka, , Japan

Site Status

GSK Investigational Site

Shizuoka, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Wakayama, , Japan

Site Status

Countries

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Japan

References

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Kitakaze M, Sarai N, Ando H, Sakamoto T, Nakajima H. Safety and tolerability of once-daily controlled-release carvedilol 10-80 mg in Japanese patients with chronic heart failure. Circ J. 2012;76(3):668-74. doi: 10.1253/circj.cj-11-0210. Epub 2012 Jan 12.

Reference Type BACKGROUND
PMID: 22240593 (View on PubMed)

Study Documents

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Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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CRV110734

Identifier Type: -

Identifier Source: org_study_id

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