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

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NCT00796666

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Study Location
Pfizer Investigational Site
Fountain Valley, California, 92708, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Arterial Hypertension, Pulmonary Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Previously enrolled in B1321001 (NCT00795639) and completed the 12-week study as planned.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Treated with an investigational drug, other than sitaxsentan sodium in B1321001
(NCT00795639), or device that has not received regulatory approval within the 30 days
prior to Baseline/Day 1 or during the study.

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  1. Fountain Valley, California
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  13. Omaha, Nebraska
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  16. Stony Brook, New York
  17. Chapel Hill, North Carolina
  18. Cincinnati, Ohio
  19. Cleveland, Ohio
  20. Lancaster, Pennsylvania
  21. Lancaster, Pennsylvania
  22. Philadelphia, Pennsylvania
  23. Pittsburgh, Pennsylvania
  24. Providence, Rhode Island
  25. Charleston, South Carolina
  26. Dallas, Texas
  27. Houston, Texas
  28. San Antonio, Texas
  29. Temple, Texas
  30. Lynchburg, Virginia
  31. Richmond, Virginia
  32. Milwaukee, Wisconsin
  33. Buenos Aires,
  34. Buenos Aires,
  35. Buenos Aires,
  36. Buenos Aires,
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NCT00796666
  1. Fountain Valley, California
  2. Gainesville, Florida
  3. Weston, Florida
  4. Boston, Massachusetts
  5. Omaha, Nebraska
  6. Chapel Hill, North Carolina
  7. Cincinnati, Ohio
  8. Cleveland, Ohio
  9. Providence, Rhode Island
  10. Houston, Texas
  11. San Antonio, Texas
  12. Milwaukee, Wisconsin
  13. Buenos Aires,
  14. Buenos Aires,
  15. Buenos Aires,
  16. Buenos Aires,
  17. Sofia,
  18. Temuco,
  19. Changsha, Hunan
  20. Beijing,
  21. Shanghai,
  22. Shanghai,
  23. Bogotá, Cundinamarca
  24. Praha 2,
  25. Hyderabad, Andhra Pradesh
  26. Hyderabad, Andhra Pradesh
  27. Ahmedabad, Gujarat
  28. Ahmedabad, Gujarat
  29. Surat, Gujarat
  30. Vadodara, Gujarat
  31. Pune, Maharashtra
  32. Coimbatore, Tamil Nadu
  33. Madurai, Tamil Nadu
  34. Georgetown, Penang
  35. Monterrey, Nuevo Leon
  36. Lima,
  37. Cluj Napoca,
  38. Iasi,
  39. Moscow,
  40. Moscow,
  41. Saint-Petersburg,
  42. Saint-Petersburg,
  43. Belgrade,
  44. Johannesburg,
  45. Bangkoknoi, Bangkok
  46. Istanbul, Fatih,
  47. Kyiv,
  48. Kyiv,
ALL GENDERS
16 Years+
years
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Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE A Phase 3, Multi-Center, Randomized, Double-Blind, Efficacy And Safety Study Of Monotherapy Sitaxsentan Sodium Versus Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension Who Have Completed Study B1321001 (NCT00795639)
Brief Summary As monotherapy for pulmonary arterial hypertension (PAH) begins to fail additional therapies are introduced. Although co-administration of sitaxsentan and sildenafil is well tolerated the controlled safety/efficacy database of the combination is limited.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Arterial Hypertension
  • Pulmonary Hypertension
Intervention  ICMJE
  • Drug: Sitaxsentan
    Sitaxsentan = 100 mg tablet administered orally, once daily Sildenafil placebo = 1 tablet administered orally, three times a day
  • Drug: Sitaxsentan and Sildenafil
    Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day
Study Arms  ICMJE
  • Experimental: Sitaxsentan and Placebo
    Monotherapy arm
    Intervention: Drug: Sitaxsentan
  • Experimental: Sitaxsentan and Sildenafil
    Combination treatment
    Intervention: Drug: Sitaxsentan and Sildenafil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 18, 2011)		131
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2008)		180
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Previously enrolled in B1321001 (NCT00795639) and completed the 12-week study as planned.

Exclusion Criteria:

  • Treated with an investigational drug, other than sitaxsentan sodium in B1321001 (NCT00795639), or device that has not received regulatory approval within the 30 days prior to Baseline/Day 1 or during the study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 16 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Bulgaria,   Chile,   China,   Colombia,   Czech Republic,   India,   Malaysia,   Mexico,   Peru,   Romania,   Russian Federation,   Serbia,   South Africa,   Thailand,   Turkey,   Ukraine,   United States
Removed Location Countries Costa Rica,   Dominican Republic,   Philippines,   Saudi Arabia,   Slovakia
 
Administrative Information
NCT Number  ICMJE NCT00796666
Other Study ID Numbers  ICMJE B1321003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP