Last updated: 02/14/2022 12:20:09
Drug Use Investigation for VOLIBRIS® (ambrisentan) (Pulmonary arterial hypertension)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Drug Use Investigation for VOLIBRIS® (ambrisentan) (Pulmonary arterial hypertension)
Trial description: 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 practice3）Factors influencing safety of ambrisentan4）Factors influencing efficacy of ambrisentan5）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.)
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The number of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan
Timeframe: 1 year
The onset statuses of anemia, fluid retention, cardiac failure and hemorrhage
Timeframe: 1 year
The number of adverse events and clinical course in subjects with hepatic dysfunction
Timeframe: 1 year
Secondary outcomes:
Not applicable
Interventions:
Drug: Ambrisentan
Enrollment:
900
Observational study model:
Other
Primary completion date:
2020-28-02
Time perspective:
Other
Clinical publications:
Yuna Onaka, Yasuo Nakajima, Kiyomi Aizawa, Ayano Fukudomi, Kyomi Kanaya, Daisaku Yasui, Naohiro Takahashi. Evaluation of safety and effectiveness of ambrisentan in patients with pulmonary arterial hypertension (PAH) – Final report of the drug use investigation (DUI). Ther Res. 2022;43(1):29-45
DOI: NULL
PMID: NULL
Medical condition
Hypertension, Pulmonary
Product
ambrisentan
Collaborators
Not applicable
Study date(s)
December 2010 to February 2020
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- Must use ambrisentan for the first time
- Subjects with hypersensitivity to ambrisentan
- Subjects who is pregnant or might be pregnant
Inclusion and exclusion 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
Trial location(s)
No location data available.
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2020-28-02
Actual study completion date
2020-28-02
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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