Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)
1 other identifier
observational
900
0 countries
N/A
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.)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2010
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 14, 2010
CompletedFirst Submitted
Initial submission to the registry
July 28, 2011
CompletedFirst Posted
Study publicly available on registry
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2020
CompletedSeptember 3, 2020
September 1, 2020
9.2 years
July 28, 2011
September 2, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
The number of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan
1 year
The onset statuses of anemia, fluid retention, cardiac failure and hemorrhage
1 year
The number of adverse events and clinical course in subjects with hepatic dysfunction
1 year
Study Arms (1)
Subjects prescribed ambrisentan
Subjects with pulmonary arterial hypertension (PAH) prescribed ambrisentan during study period
Interventions
Eligibility Criteria
All Japanese subjects who have received ambrisentan for the first time for the treatment of pulmonary arterial hypertension (PAH) and have given their consent to participate in the study.
You may qualify if:
- Must use ambrisentan for the first time
You may not qualify if:
- Subjects with hypersensitivity to ambrisentan
- Subjects who is pregnant or might be pregnant
- Subjects with severe hepatic disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Related Publications (1)
Takahashi T, Hayata S, Kobayashi A, Onaka Y, Ebihara T, Hara T. Surveillance on The Safety and Efficacy of Ambrisentan (Volibris Tablet 2.5 mg) in Patients with Pulmonary Arterial Hypertension in Real Clinical Practice: Post-marketing Surveillance (Interim Analysis Report). Clin Drug Investig. 2018 Mar;38(3):219-229. doi: 10.1007/s40261-017-0602-4.
PMID: 29282676DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2011
First Posted
August 1, 2011
Study Start
December 14, 2010
Primary Completion
February 28, 2020
Study Completion
February 28, 2020
Last Updated
September 3, 2020
Record last verified: 2020-09