Last updated: 11/07/2018 15:27:28
A Study to Evaluate GSK1325760A - a Long-Term Extension Study
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Study AMB107818, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An open label Study of GSK1325760A to evaluate the Safety and Efficacy of GSK1325760A - a Long-term Extension Study -
Trial description: The primary objective of this study is to evaluate the safety of long-term administration of GSK1325760A in patients with PAH.The secondary objectives of this study are to evaluate long-term administration of GSK1325760A on:-Improvement in exercise capacity (six-minutes walk distance: 6MWD), change in WHO Functional Classification and time to clinical worsening of PAH-Change in the Borg Dyspnea Index (assessed immediately following the six-minute walk test [6MWT])-Change in plasma brain natriuretic peptide (BNP) levels-Cardiopulmonary hemodynamics parameters (as measured by echocardiography)
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of Participants with Any Adverse Event
Timeframe: For 140.57 weeks at maximum, starting from Week 24
Number of Participants with Adverse Events Categorized by Severity
Timeframe: For 140.57 weeks at maximum, starting from Week 24
Secondary outcomes:
Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Timeframe: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Timeframe: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 159.85)
Number of Participants with the Indicated Change from Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Timeframe: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 164.14)
Number of Participants with the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH), Assessed as the First Occurrence of a Particular Event
Timeframe: Up to 164.14 weeks
Mean Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Timeframe: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 153)
Mean Change From Baseline in Cardiac Output (CO) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Timeframe: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 156.14)
Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Timeframe: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 164.14)
Interventions:
Drug: GSK1325760A
Enrollment:
21
Observational study model:
Not applicable
Primary completion date:
2011-18-01
Time perspective:
Not applicable
Clinical publications:
Yoshida S, Shirato K, Shimamura R, Iwase T, Aoyagi N, Nakajima H. Long-term safety and efficacy of ambrisentan in Japanese adults with PAH. Curr Med Res Opin.2011;27(9):1827-1834.
Medical condition
Pulmonary arterial hypertension, Hypertension, Pulmonary
Product
ambrisentan
Collaborators
Not applicable
Study date(s)
February 2008 to January 2011
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
No
- Subjects who complete the 24-week administration of the Phase II/III study (Study No.AMB107816)
- Subjects who are assessed that the long-term extension administration of GSK1325760A is appropriate in the judgement of the investigator or subinvestigator
- Subjects who have been withdrawn from the Phase II/III study.
- Female subjects who wish to become pregnant.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who complete the 24-week administration of the Phase II/III study (Study No.AMB107816)
- Subjects who are assessed that the long-term extension administration of GSK1325760A is appropriate in the judgement of the investigator or subinvestigator
- Subjects who request the long-term extension administration of GSK1325760A, and agree to newly sign the informed consent form
Exclusion criteria:
- Subjects who have been withdrawn from the Phase II/III study.
- Female subjects who wish to become pregnant.
- Treatment with other PAH medication is needed.
- A worsening of 2 or more levels of the WHO Functional Classification (see Appendix 2.1) comparing with the baseline of Phase II/III study (Study No.AMB107816).
- Worsening of right ventricular failure (e.g. as indicated by increased jugular venous pressure, new/worsened hepatomegaly, ascites, or peripheral edema) during Phase II/III study (Study No.AMB107816).
- Rapidly progressing cardiac, hepatic or renal failure during Phase II/III study (Study No.AMB107816).
- Participation to the long-term extension study is considered as inappropriate in the judgment of the investigator or subinvestigator.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2011-18-01
Actual study completion date
2011-18-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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