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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00540436
First Posted: October 8, 2007
Last Update Posted: October 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: August 10, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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.
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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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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


  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


Publications:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00540436     History of Changes
Other Study ID Numbers: AMB107816
First Submitted: October 5, 2007
First Posted: October 8, 2007
Results First Submitted: August 10, 2009
Results First Posted: November 10, 2009
Last Update Posted: October 15, 2012