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

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NCT00811018

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233, 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:

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Pfizer Clinical Trials Contact Center

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
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.

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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