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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01387191
First Posted: July 4, 2011
Last Update Posted: May 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose

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 Intervention
Cardiovascular Disease Drug: Epoprostenol

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Drug Use Investigation for FLOLAN (Epoprostenol) Injection 0.5mg・1.5mg

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Enrollment: 748
Study Start Date: August 1999
Study Completion Date: July 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects prescribed epoprostenol
Subjects with pulmonary arterial hypertension prescribed epoprostenol injection during study period
Drug: Epoprostenol

  Eligibility

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
  Contacts and Locations
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
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01387191     History of Changes
Other Study ID Numbers: 112300
First Submitted: June 30, 2011
First Posted: July 4, 2011
Last Update Posted: May 16, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Cardiovascular Diseases