Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)

NCT00795639

Last updated date
Study Location
Pfizer Investigational Site
Fountain Valley, California, 92708, United States
Contact
1-800-718-1021

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1-800-718-1021

By email

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[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

- Current diagnosis of symptomatic pulmonary arterial hypertension (PAH) classified by one of the following: idiopathic arterial hypertension (IPAH), primary pulmonary hypertension (PPH), familial pulmonary arterial hypertension (FPAH) or pulmonary arterial hypertension (PAH) associated with connective tissue diseases. Has WHO functional class III symptoms.

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


- Previous exposure to an endothelin receptor antagonist (ETRA) such as sitaxsentan,
bosentan or ambrisentan.

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NCT00795639
  1. Fountain Valley, California
  2. Mather, California
  3. Sacramento, California
  4. Englewood, Colorado
  5. Littleton, Colorado
  6. Gainesville, Florida
  7. Sarasota, Florida
  8. Weston, Florida
  9. Chicago, Illinois
  10. Olathe, Kansas
  11. Towson, Maryland
  12. Boston, Massachusetts
  13. Omaha, Nebraska
  14. New Brunswick, New Jersey
  15. Islandia, New York
  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,
  37. Sofia,
  38. Sofia,
  39. Veliko Turnovo,
  40. Temuco,
  41. Changsha, Hunan
  42. Xi'an, Shanxi
  43. Beijing,
  44. Shanghai,
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  46. Bogotá, Cundinamarca
  47. Escazu, San Jose
  48. Praha 2,
  49. Santo Domingo, República Dominicana
  50. Santo Domingo,
  51. Guatemala,
  52. Hyderabad, Andhera Pradesh
  53. Hyderabad, Andhra Pradesh
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  55. Surat, Gujarat
  56. Vadodara, Gujarat
  57. Pune, Maharashtra
  58. Coimbatore, Tamil Nadu
  59. Madurai, Tamil Nadu
  60. Georgetown, Penang
  61. Mexico, DF
  62. Mexico, DF
  63. Monterrey, Nuevo Leon
  64. Lima,
  65. Lima,
  66. Quezon City,
  67. Cluj Napoca,
  68. Iasi,
  69. Moscow,
  70. Moscow,
  71. Saint-Petersburg,
  72. Saint-Petersburg,
  73. Saint-Petersburg,
  74. Riyadh,
  75. Belgrade,
  76. Bratislava,
  77. Cape Town, Western Cape
  78. Cape Town,
  79. Johannesburg,
  80. Stellenbosch,
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  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,
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16 Years+
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Advanced Information
Descriptive Information
Brief Title  ICMJE Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)
Official Title  ICMJE A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety And Efficacy Study Of Sitaxsentan Sodium In Subjects With Pulmonary Arterial Hypertension
Brief Summary This protocol is for subjects with pulmonary arterial hypertension and is the first of 3 studies forming the Sitaxsentan efficacy and safety trial with Randomized Prospective Assessment of Adding Sildenafil (SR-PAAS) program.
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
  • Drug: Placebo
    Sitaxsentan Placebo = 1 tablet administered orally, once daily
    Other Name: Sitaxsentan Placebo
Study Arms  ICMJE
  • Experimental: Sitaxsentan
    Monotherapy
    Intervention: Drug: Sitaxsentan
  • Placebo Comparator: Sitaxsentan Placebo
    Monotherapy
    Intervention: Drug: Placebo
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)
183
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:

  • Current diagnosis of symptomatic pulmonary arterial hypertension (PAH) classified by one of the following: idiopathic arterial hypertension (IPAH), primary pulmonary hypertension (PPH), familial pulmonary arterial hypertension (FPAH) or pulmonary arterial hypertension (PAH) associated with connective tissue diseases. Has WHO functional class III symptoms.

Exclusion Criteria:

  • Previous exposure to an endothelin receptor antagonist (ETRA) such as sitaxsentan, bosentan or ambrisentan.
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,   Costa Rica,   Czech Republic,   Dominican Republic,   Guatemala,   India,   Malaysia,   Mexico,   Peru,   Philippines,   Romania,   Russian Federation,   Saudi Arabia,   Serbia,   Slovakia,   South Africa,   Thailand,   Turkey,   Ukraine,   United States
Removed Location Countries Egypt,   Jordan,   Lebanon,   United Arab Emirates
 
Administrative Information
NCT Number  ICMJE NCT00795639
Other Study ID Numbers  ICMJE B1321001
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