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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01406327
• Collaborator: (none)
• Enrollment: 900
• Actual Duration (Months): 110.5

Study Details

Study Description

Brief 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.)

Condition or Disease	Intervention/Treatment	Phase
Hypertension, Pulmonary	Drug: Ambrisentan

Study Design

• Study Type: Observational
• Anticipated Enrollment: 900 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)
• Actual Study Start Date: Dec 14, 2010
• Actual Primary Completion Date: Feb 28, 2020
• Actual Study Completion Date: Feb 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Subjects prescribed ambrisentan Subjects with pulmonary arterial hypertension (PAH) prescribed ambrisentan during study period	Drug: Ambrisentan; Ambrisentan

Outcome Measures

Primary Outcome Measures

1. The number of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan [1 year]

2. The onset statuses of anemia, fluid retention, cardiac failure and hemorrhage [1 year]

3. The number of adverse events and clinical course in subjects with hepatic dysfunction [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01406327
• Other Study ID Numbers: 114782
• First Posted: Aug 1, 2011
• Last Update Posted: Sep 3, 2020
• Last Verified: Sep 1, 2020

• Additional relevant MeSH terms: Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Hypertension; Ambrisentan

Study Results

No Results Posted as of Sep 3, 2020