Drug Use Investigation for FLOLAN (Epoprostenol) Injection 0.5mg・1.5mg

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01387191

First received: June 30, 2011

Last updated: NA

Last verified: June 2011

History: No changes posted

Tracking Information

First Received Date ^ICMJE

June 30, 2011

Last Updated Date

June 30, 2011

Start Date ^ICMJE

August 1999

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The number of incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with epoprostenol injection [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Drug Use Investigation for FLOLAN (Epoprostenol) Injection 0.5mg・1.5mg

Official Title ^ICMJE

Drug Use Investigation for FLOLAN (Epoprostenol) Injection 0.5mg・1.5mg

Brief Summary

The objective of this study is to evaluate the incidence of adverse events in Japanese pulmonary arterial hypertension subjects treated with epoprostenol injection based on prescribing information under the conditions of general clinical practice and also to grasp the following items;

Unknown adverse reactions (especially, significant adverse reactions)
Adverse reaction onset status under practical drug use conditions
Factors possibly influential on safety
Factors possibly influential on efficacy
Patient's prognosis, efficacy and safety in long-term use

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

All Japanese subjects with pulmonary arterial hypertension who are treated with epoprostenol injection

Condition ^ICMJE

Cardiovascular Disease

Intervention ^ICMJE

Drug: Epoprostenol

Study Group/Cohort (s)

Subjects prescribed epoprostenol

Subjects with pulmonary arterial hypertension prescribed epoprostenol injection during study period

Intervention: Drug: Epoprostenol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

748

Completion Date

July 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subjects with cardiovascular disease

Exclusion Criteria:

Subjects with hypersensitivity to epoprostenol
Subjects with right cardiac failure during an acute exacerbation
Subjects with severe left ventricular systolic dysfunction
Subjects with serious left ventricular dysfunction
Subjects whose pulmonary edema getting worse during dose initiation

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01387191

Other Study ID Numbers ^ICMJE

112300

Has Data Monitoring Committee

Responsible Party

Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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