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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
  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: Time Perspective: Prospective
Official Title: Drug Use Investigation for FLOLAN (Epoprostenol) Injection 0.5mg・1.5mg

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01387191

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01387191     History of Changes
Other Study ID Numbers: 112300
Study First Received: June 30, 2011
Last Updated: June 30, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Cardiovascular Diseases
Epoprostenol
Tezosentan
Platelet Aggregation Inhibitors
Hematologic Agents
 Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 21, 2013