Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00540436
First received: October 5, 2007
Last updated: October 11, 2012
Last verified: October 2012
Results First Received: August 10, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
GSK1325760A First Treatment Period: GSK1325760A 5 mg once a day. Second Treatment Period: GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition).

Participant Flow for 2 periods

Period 1:   First 12-Week Treatment Period
    GSK1325760A  
STARTED     25  
COMPLETED     22  
NOT COMPLETED     3  
Adverse Event                 1  
Withdrawal by Subject                 1  
Initiation of prohibited medication                 1  

Period 2:   Second 12-Week Treatment Period
    GSK1325760A  
STARTED     22  
COMPLETED     21  
NOT COMPLETED     1  
Adverse Event                 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 GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition).

Baseline Measures
    GSK1325760A  
Number of Participants  
[units: participants]
  25  
Age  
[units: years]
Mean ± Standard Deviation
  45.5  ± 13.66  
Gender  
[units: participants]
 
Female     22  
Male     3  
Race/Ethnicity, Customized  
[units: participants]
 
Asian-Japanese Heritage     25  



  Outcome Measures
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1.  Primary:   Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 12   [ Time Frame: Baseline and Week 12 ]

2.  Secondary:   Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24/Withdrawal   [ Time Frame: Baseline and Week 24/Withdrawal ]

3.  Secondary:   Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24   [ Time Frame: Baseline and Weeks 12 and 24 ]

4.  Secondary:   Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24   [ Time Frame: Weeks 12 and 24 ]

5.  Secondary:   Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH) at Week 24, Assessed as the First Occurrence of a Particular Event   [ Time Frame: Week 24 ]

6.  Secondary:   Mean Change From Baseline in Mean Pulmonary Atery Pressure (mPAP) and Mean Right Atrial Pressure (mRAP) at Weeks 12 and 24   [ Time Frame: Baseline and Weeks 12 and 24 ]

7.  Secondary:   Mean Change From Baseline in Cardiac Index (CI) at Weeks 12 and 24   [ Time Frame: Baseline and Weeks 12 and 24 ]

8.  Secondary:   Mean Change From Baseline in Cardiac Output (CO) at Weeks 12 and 24   [ Time Frame: Baseline and Weeks 12 and 24 ]

9.  Secondary:   Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) at Weeks 12 and 24   [ Time Frame: Baseline and Weeks 12 and 24 ]

10.  Secondary:   Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 12 and 24   [ Time Frame: Baseline and Weeks 12 and 24 ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


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: NCT00540436     History of Changes
Other Study ID Numbers: AMB107816
Study First Received: October 5, 2007
Results First Received: August 10, 2009
Last Updated: October 11, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare