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

NCT00811018

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233, United States
Contact
1-800-718-1021

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]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Arterial Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of Pulmonary Arterial Hypertension (PAH) confirmed by cardiac catheterization.

- Current diagnosis of WHO group 1 PAH with functional class 2, 3, or 4 symptoms.

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


- Has portal hypertension or chronic liver disease.


- Has history of left sided heart disease or significant cardiac disease.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Pulmonary Arterial HypertensionPatient Reported Outcomes in Pulmonary Arterial Hypertension
NCT01792622
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Pulmonary Arterial HypertensionOpen Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study
NCT00878943
  1. Hyderabad, Andra Pradesh
  2. Ahmedabad, Gujarat
  3. Vadodara, Gujarat
  4. Bangalore, Karnataka
  5. Noida, Uttar Pradesh
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Pulmonary Arterial HypertensionAssess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension
NCT00323297
  1. Los Angeles, California
  2. Detroit, Michigan
  3. Pittsburgh, Pennsylvania
  4. Houston, Texas
  5. Houston, Texas
  6. San Antonio, Texas
  7. Darlinghurst, New South Wales
  8. Chermside, Queensland
  9. Praha 2,
  10. Praha 4,
  11. Lille,
  12. Lille,
  13. Vandoeuvre Les Nancy,
  14. Berlin,
  15. Coburg,
  16. Essen,
  17. Giessen,
  18. Hannover,
  19. Homburg,
  20. Leipzig,
  21. Muenchen,
  22. Nuernberg,
  23. Wuerzburg,
  24. Haidari, Athens
  25. Haifa,
  26. Petach Tikva,
  27. Napoli,
  28. Roma,
  29. Taipei,
  30. Papworth Everard, Cambridgeshire
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Pulmonary Arterial HypertensionTo Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.
NCT00430716
  1. Phoenix, Arizona
  2. Augusta, Georgia
  3. Decatur, Georgia
  4. Elk Grove Village, Illinois
  5. Indianapolis, Indiana
  6. Chapel Hill, North Carolina
  7. Charlotte, North Carolina
  8. Houston, Texas
  9. Salt Lake City, Utah
  10. Richmond, Virginia
  11. Richmond, Virginia
  12. Leuven,
  13. Porto Alegre, RS
  14. Sao Paulo, SP
  15. Sofia,
  16. Sofia,
  17. Beijing,
  18. Shanghai,
  19. Haidari, Athens
  20. Hyderabad, Andhra Pradesh
  21. Ahmedabad, Gujarat
  22. Vadodara, Gujarat
  23. Bangalore, Karnataka
  24. Noida, Uttar Pradesh
  25. Pavia,
  26. Roma,
  27. Riga,
  28. Kuala Lumpur,
  29. Amsterdam,
  30. Rotterdam,
  31. Manila City,
  32. Quezon City,
  33. Krakow,
  34. Zabrze,
  35. Timisoara, Timis
  36. Iasi,
  37. Moscow,
  38. Moscow,
  39. Amphoe Mueang, Khon Kaen
  40. Bangkok,
  41. Norwich, Norfolk
  42. Newcastle Upon Tyne, Tyne and Wear
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension
Official Title  ICMJE A Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial Hypertension
Brief Summary This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH until sitaxsentan, in a particular country or region, is commercially available for the treatment of PAH or the study is closed.
Detailed Description Open-label extension
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Pulmonary Arterial Hypertension
Intervention  ICMJE Drug: Sitaxsentan
Sitaxsentan 100 mg tablets once daily
Other Name: Sitaxentan
Study Arms  ICMJE Experimental: Sitaxsentan
Sitaxsentan
Intervention: Drug: Sitaxsentan
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: February 16, 2012)
1192
Original Actual Enrollment  ICMJE
 (submitted: December 16, 2008)
1208
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of Pulmonary Arterial Hypertension (PAH) confirmed by cardiac catheterization.
  • Current diagnosis of WHO group 1 PAH with functional class 2, 3, or 4 symptoms.

Exclusion Criteria:

  • Has portal hypertension or chronic liver disease.
  • Has history of left sided heart disease or significant cardiac disease.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 12 Years to 75 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,   Australia,   Austria,   Belgium,   Brazil,   Canada,   France,   Germany,   Israel,   Italy,   Mexico,   Netherlands,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00811018
Other Study ID Numbers  ICMJE B1321007
FPH03
Has Data Monitoring Committee No
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 November 2011

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