- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01387191
Drug Use Investigation for FLOLAN (Epoprostenol) Injection 0.5mg・1.5mg
May 15, 2017 updated by: GlaxoSmithKline
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
Study Overview
Study Type
Observational
Enrollment (Actual)
748
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All Japanese subjects with pulmonary arterial hypertension who are treated with epoprostenol injection
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Subjects prescribed epoprostenol
Subjects with pulmonary arterial hypertension prescribed epoprostenol injection during study period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with epoprostenol injection
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 1999
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
June 30, 2011
First Submitted That Met QC Criteria
June 30, 2011
First Posted (Estimate)
July 4, 2011
Study Record Updates
Last Update Posted (Actual)
May 16, 2017
Last Update Submitted That Met QC Criteria
May 15, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 112300
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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