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Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)

NCT01406327 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 900

Last updated 2020-09-03

No results posted yet for this study

Summary

The objective of this post-marketing surveillance study is to evaluate the incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan basd on prescribing information under the conditions of general clinical practice and also to grasp the following items;

1. Unknown adverse drug reactions (ADRs)
2. Incidence of ADRs to medical products in actual clinical practice
3. Factors influencing safety of ambrisentan
4. Factors influencing efficacy of ambrisentan
5. Prognosis of subjects as well as efficacy and safety of ambrisentan in long-term use (VOLIBRIS® is a trademark of Gilead Sciences, Inc,. that GSK uses under license.)

Conditions

  • Hypertension, Pulmonary

Interventions

DRUG

Ambrisentan

Ambrisentan

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-14
Primary Completion
2020-02-28
Completion
2020-02-28

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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 NCT01406327 on ClinicalTrials.gov