Last updated: 11/07/2018 15:27:28

A Study to Evaluate GSK1325760A - a Long-Term Extension Study

GSK study ID
AMB107818
See study documents
Clinicaltrials.gov ID
NCT00554619
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2011-18-01
    Observational study model:
    Not applicable
    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)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Okayama, Japan, 701-1192
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kanagawa, Japan, 252-0375
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tokyo, Japan, 113-8655
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Aichi, Japan, 470-1192
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Osaka, Japan, 565-8565
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hokkaido, Japan, 060-8543
    Status
    Study Complete
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    Showing 1 - 6 of 11 Results

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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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