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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00554619
First received: November 5, 2007
Last updated: November 1, 2012
Last verified: October 2012
Results First Received: October 20, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Pulmonary Arterial Hypertension
Hypertension, Pulmonary
Intervention: Drug: GSK1325760A

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study AMB107818 was an extension study of Study AMB107816 (NCT00540436).

Reporting Groups
  Description
GSK1325760A Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.

Participant Flow:   Overall Study
    GSK1325760A  
STARTED     21  
COMPLETED     18  
NOT COMPLETED     3  
Adverse Event                 1  
Physician Decision                 1  
Liver Function Test Abnormality                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
GSK1325760A Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.

Baseline Measures
    GSK1325760A  
Number of Participants  
[units: participants]
  21  
Age  
[units: Years]
Mean ± Standard Deviation
  45.6  ± 12.62  
Gender  
[units: Participants]
 
Female     18  
Male     3  
Race/Ethnicity, Customized  
[units: participants]
 
Asian – Japanese Heritage     21  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Any Adverse Event   [ Time Frame: For 140.57 weeks at maximum, starting from Week 24 ]

2.  Primary:   Number of Participants With Adverse Events Categorized by Severity   [ Time Frame: For 140.57 weeks at maximum, starting from Week 24 ]

3.  Secondary:   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   [ Time Frame: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156 ]

4.  Secondary:   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   [ Time Frame: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 159.85) ]

5.  Secondary:   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   [ Time Frame: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 164.14) ]

6.  Secondary:   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   [ Time Frame: Up to 164.14 weeks ]

7.  Secondary:   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   [ Time Frame: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 153) ]

8.  Secondary:   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   [ Time Frame: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 156.14) ]

9.  Secondary:   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   [ Time Frame: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 164.14) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00554619     History of Changes
Other Study ID Numbers: AMB107818
Study First Received: November 5, 2007
Results First Received: October 20, 2011
Last Updated: November 1, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare