NCT01387191

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
748

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 1999

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2011

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

9.7 years

First QC Date

June 30, 2011

Last Update Submit

May 15, 2017

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

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

    12 weeks

Study Arms (1)

Subjects prescribed epoprostenol

Subjects with pulmonary arterial hypertension prescribed epoprostenol injection during study period

Drug: Epoprostenol

Interventions

EpoprostenolDRUG
Subjects prescribed epoprostenol

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All Japanese subjects with pulmonary arterial hypertension who are treated with epoprostenol injection

You may qualify if:

  • Subjects with cardiovascular disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Epoprostenol

Intervention Hierarchy (Ancestors)

Prostaglandins IProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2011

First Posted

July 4, 2011

Study Start

August 1, 1999

Primary Completion

April 1, 2009

Study Completion

July 1, 2009

Last Updated

May 16, 2017

Record last verified: 2017-05