Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil

This study has been terminated.
(Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00796666
First received: November 20, 2008
Last updated: March 6, 2012
Last verified: May 2011
Results First Received: January 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Pulmonary Arterial Hypertension
Pulmonary Hypertension
Interventions: Drug: Sitaxsentan
Drug: Sitaxsentan and Sildenafil

  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
Participants who successfully completed treatment in study B1321001 (NCT00795639).

Reporting Groups
  Description
Sitaxsentan and Placebo Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
Sitaxsentan and Sildenafil Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID

Participant Flow:   Overall Study
    Sitaxsentan and Placebo     Sitaxsentan and Sildenafil  
STARTED     67     64  
Treated     66     64  
Randomized and Not Treated     1     0  
COMPLETED     0     0  
NOT COMPLETED     67     64  
Death                 2                 4  
Withdrawal by Subject                 2                 0  
Adverse Event                 7                 5  
Protocol Violation                 1                 0  
Unspecified                 1                 0  
Terminated by sponsor                 53                 55  
Randomized and not treated                 1                 0  



  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
Sitaxsentan and Placebo Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
Sitaxsentan and Sildenafil Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
Total Total of all reporting groups

Baseline Measures
    Sitaxsentan and Placebo     Sitaxsentan and Sildenafil     Total  
Number of Participants  
[units: participants]
  67     64     131  
Age, Customized  
[units: participants]
     
less than 18 years     1     0     1  
18-44 years     38     41     79  
45-64 years     20     18     38  
>= 65 years     8     5     13  
Gender  
[units: participants]
     
Female     55     49     104  
Male     12     15     27  
World Health Organization (WHO) Functional Classification [1]
[units: number]
     
Functional Class I     0     0     0  
Functional Class II     12     11     23  
Functional Class III     55     52     107  
Functional Class IV     0     1     1  
[1] WHO Pulmonary Atrial Hypertension (PAH) Functional Classification: I (no limitation on physical activity), II (slight limitation on ordinary physical activity), III (marked limitations on physical activity comfortable at rest) and IV (unable to carry out any physical activity without symptoms, dyspnea and fatigue present at rest).



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Clinical Worsening (TTCW)   [ Time Frame: Baseline, Weeks 12, 24 or Early Termination (ET) ]

2.  Secondary:   Change From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD)   [ Time Frame: Baseline to Weeks 12 and 24 ]

3.  Secondary:   Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Weeks 12, 24, 48   [ Time Frame: Baseline, Weeks 12, 24 or ET ]

4.  Secondary:   Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Physical Functioning Domain   [ Time Frame: Baseline, Weeks 12, 24 and ET ]

5.  Secondary:   Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitations Due to Physical Health Problems Domain   [ Time Frame: Baseline, Weeks 12, 24 or ET ]

6.  Secondary:   Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Bodily Pain Domain   [ Time Frame: Baseline, Weeks 12, 24 or ET ]

7.  Secondary:   Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - General Health Domain   [ Time Frame: Baseline, Weeks 12, 24 or ET ]

8.  Secondary:   Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Vitality Domain   [ Time Frame: Baseline, Weeks 12, 24 or ET ]

9.  Secondary:   Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Social Functioning Domain   [ Time Frame: Baseline, Weeks 12, 24 or ET ]

10.  Secondary:   Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitation Due to Emotional Problems Domain   [ Time Frame: Baseline, Weeks 12, 24 or ET ]

11.  Secondary:   Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Mental Health Domain   [ Time Frame: Baseline, Weeks 12, 24 or ET ]

12.  Secondary:   Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Mental Health   [ Time Frame: Baseline, Weeks 12, 24 or ET ]

13.  Secondary:   Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Physical Health   [ Time Frame: Baseline, Weeks 12, 24 or ET ]


  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
Study terminated early by sponsor, no Week 48 information collected.


  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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00796666     History of Changes
Other Study ID Numbers: B1321003
Study First Received: November 20, 2008
Results First Received: January 26, 2012
Last Updated: March 6, 2012
Health Authority: United States: Food and Drug Administration