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

NCT01387191 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 748

Last updated 2017-05-16

No results posted yet for this study

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

Conditions

Interventions

DRUG

Epoprostenol

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-08-31
Primary Completion
2009-04-30
Completion
2009-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01387191 on ClinicalTrials.gov