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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension, Pulmonary

Intervention: Ambrisentan (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.)

Clinical Details

Official title: Drug Use Investigation for VOLIBRIS (Ambrisentan) (Pulmonary Arterial Hypertension)

Study design: N/A

Primary outcome:

The number of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan

The onset statuses of anemia, fluid retention, cardiac failure and hemorrhage

The number of adverse events and clinical course in subjects with hepatic dysfunction

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Must use ambrisentan for the first time

Exclusion Criteria:

- Subjects with hypersensitivity to ambrisentan

- Subjects who is pregnant or might be pregnant

- Subjects with severe hepatic disorder

Locations and Contacts

Additional Information

Starting date: December 2010
Last updated: July 24, 2014

Page last updated: August 23, 2015

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