Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety

NCT00796510

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

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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 for at least 4 weeks.

- Previously enrolled in B1321003, discontinued from the study.

- Completed the B1321003 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 or sildenafil in either
B1321001 or B1321003) 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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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety
Official Title  ICMJE A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension
Brief Summary As sitaxsentan is the agent most highly selective for ETA (Endothelin Type A (receptor)), and does not significantly impact sildenafil pharmacokinetics the combination of most promise for pulmonary arterial hypertension (PAH) therapy is these two oral drugs administered in combination.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Arterial Hypertension
  • Pulmonary Hypertension
Intervention  ICMJE
  • Drug: Sitaxsentan
    Sitaxsentan = 100 mg tablet administered orally, once daily
  • 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
    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: March 14, 2011)
3
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2008)
180
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Previously enrolled in B1321001 for at least 4 weeks.
  • Previously enrolled in B1321003, discontinued from the study.
  • Completed the B1321003 study as planned.

Exclusion Criteria:

  • Treated with an investigational drug (other than sitaxsentan or sildenafil in either B1321001 or B1321003) 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 Romania,   Ukraine,   United States
Removed Location Countries Argentina,   Bulgaria,   Chile,   China,   Colombia,   Costa Rica,   Czech Republic,   Dominican Republic,   India,   Mexico,   Peru,   Philippines,   Russian Federation,   Saudi Arabia,   Serbia,   Slovakia,   South Africa,   Thailand
 
Administrative Information
NCT Number  ICMJE NCT00796510
Other Study ID Numbers  ICMJE B1321002
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 September 2018

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