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

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ClinicalTrials.gov Identifier: NCT01387191
Recruitment Status : Completed
First Posted : July 4, 2011
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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;

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

Condition or disease Intervention/treatment
Cardiovascular Disease Drug: Epoprostenol

Study Type : Observational
Actual Enrollment : 748 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Drug Use Investigation for FLOLAN (Epoprostenol) Injection 0.5mg・1.5mg
Study Start Date : August 1999
Actual Primary Completion Date : April 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Subjects prescribed epoprostenol
Subjects with pulmonary arterial hypertension prescribed epoprostenol injection during study period
Drug: Epoprostenol



Primary Outcome Measures :
  1. The number of incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with epoprostenol injection [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All Japanese subjects with pulmonary arterial hypertension who are treated with epoprostenol injection
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387191


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01387191     History of Changes
Other Study ID Numbers: 112300
First Posted: July 4, 2011    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Cardiovascular Diseases