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OpenTrials
Completed

NCT Number: NCT01387191

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

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

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epoprostenol

Drug

Primary outcomes

  1. The number of incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with epoprostenol injection

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
1999
Primary completion
2009
Study completion
2009
First posted
Jul 4, 2011
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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