A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension (STRIDE-3)

This study has been terminated.
(This trial was prematurely terminated on Dec 9 2010 due to safety concerns, specifically emerging evidence of hepatic injury.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00811018
First received: December 9, 2008
Last updated: March 29, 2012
Last verified: November 2011
Results First Received: March 29, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Pulmonary Arterial Hypertension
Intervention: Drug: Sitaxsentan

  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
Participants were enrolled from studies FPH02/FPH02-X (STRIDE 2/STRIDE 2 Extension [NCT00080457, NCT00593905]), FPH04 (STRIDE 4), FPH06 (STRIDE 6) or were naive to sitaxsentan sodium.

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
Sitaxsentan All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.

Participant Flow:   Overall Study
    Sitaxsentan  
STARTED     1192  
COMPLETED     224  
NOT COMPLETED     968  
Additional Chronic Treatment                 31  
Adverse Event                 79  
Death                 147  
ALT/AST >3x UNL, Bilirubin >2xUNL                 4  
ALT/AST >5x Upper Limit of Normal (ULN)                 70  
Investigator Decision                 57  
Lost to Follow-up                 19  
Pregnancy                 6  
Sponsor Decision                 450  
Withdrawal by Subject                 70  
WHO FC deterioration and 6MWD decrease                 9  
Unspecified                 26  



  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 All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.

Baseline Measures
    Sitaxsentan  
Number of Participants  
[units: participants]
  1192  
Age, Customized  
[units: participants]
 
less than (<) 18 years     35  
18-44 years     433  
45-64 years     468  
greater than or equal to 65 years     256  
Gender  
[units: participants]
 
Female     914  
Male     278  



  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Day 1 up to 82 months ]

2.  Primary:   The Percentage of Participants Who Experience an Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Value Greater Than (>) 3.0 Times (x) the Upper Limit of Normal Range (ULN)   [ Time Frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months ]

3.  Primary:   The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN   [ Time Frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months ]

4.  Primary:   Percentage of Participants With Total Bilirubin > 1.5 x ULN   [ Time Frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months ]

5.  Primary:   Percentage of Participants With Laboratory Test Abnormalities (Hematology)   [ Time Frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months ]

6.  Primary:   Percentage of Participants With Laboratory Test Abnormalities (Chemistry)   [ Time Frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months ]

7.  Primary:   Percentage of Participants With Laboratory Test Abnormalities (Urinalysis)   [ Time Frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months ]

8.  Primary:   Percentage of Participants With Anticoagulant Use   [ Time Frame: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months ]

9.  Primary:   Percentage of Participants With Elevated International Normalize Ratio (INR)   [ Time Frame: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months ]

10.  Primary:   Percentage of Participants With Electrocardiography (ECG) Results of Potential Clinical Importance   [ Time Frame: Weeks 28,60,72,84,96,104, Transition Visit up to 82 months ]

11.  Primary:   Percentage of Participants With Vital Sign Results of Potential Clinical Importance   [ Time Frame: Day 1, Weeks 28,60,72,84,96,104, Transition visit, every 6 months Post Transition, up to 82 months ]

12.  Primary:   Percentage of Participants With Abnormal Prothrombin Time (PT)   [ Time Frame: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months ]

13.  Primary:   Percentage of Participants With Abnormal Partial Thromboplastin Time (PTT)   [ Time Frame: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months ]


  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
Mean and dispersion for clinical abnormalities were intended to be reported but due to early termination of study (09-Dec-2010) only number and percent of participants are available.


  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: NCT00811018     History of Changes
Other Study ID Numbers: B1321007, FPH03
Study First Received: December 9, 2008
Results First Received: March 29, 2012
Last Updated: March 29, 2012
Health Authority: United States: Food and Drug Administration