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

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NCT00796510

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Fountain Valley, California, 92708 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.

NCT00796510
Pfizer
Terminated
Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety

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Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety
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
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pulmonary Arterial Hypertension
  • Pulmonary Hypertension
  • 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
  • Experimental: Sitaxsentan
    Monotherapy arm
    Intervention: Drug: Sitaxsentan
  • Experimental: Sitaxsentan and Sildenafil
    Combination treatment
    Intervention: Drug: Sitaxsentan and Sildenafil
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
January 2011
January 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
16 Years to 80 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Romania,   Ukraine,   United States
Argentina,   Bulgaria,   Chile,   China,   Colombia,   Costa Rica,   Czech Republic,   Dominican Republic,   India,   Mexico,   Peru,   Philippines,   Russian Federation,   Saudi Arabia,   Serbia,   Slovakia,   South Africa,   Thailand
 
NCT00796510
B1321002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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[email protected]



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