Open-label Study Providing Monotherapy (Sitaxsentan) and Combination Therapy (Sitaxsentan+Sildenafil) to Subjects With PAH to Assess Long-term Safety


Tracking Information

Start Date  ICMJEDecember 2009
Estimated Primary Completion DateJanuary 2014   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2008)		The primary objective is to evaluate the long-term safety in subjects with PAH who are eligible for this study if B1321003 was completed, if early escape was met in B1321001, or early discontinuation in B1321003. [ Time Frame: Throughout ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00796510 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: November 20, 2008)		The secondary objective is to evaluate the efficacy in subjects with PAH who are eligible for this study if B1321003 was completed, if early escape was met in B1321001, or early discontinuation in B1321003 by determining change in 6MWD. [ Time Frame: Baseline/Day 1 to Weeks 12 and 24 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEOpen-label Study Providing Monotherapy (Sitaxsentan) and Combination Therapy (Sitaxsentan+Sildenafil) to Subjects With PAH to Assess Long-term Safety
Official Title  ICMJEA 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 PAH therapy is these two oral drugs administered in combination.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study
Condition  ICMJE
  • Pulmonary Arterial Hypertension
  • Pulmonary Hypertension
  • PAH
Intervention  ICMJE
  • Drug: Sitaxsentan
    Sitaxsentan = 100 mg tablet administered orally, once daily
    Other Name: Monotherapy arm
  • Drug: Sitaxsentan and Sildenafil
    Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day
    Other Name: Combination treatment
Study Arms / Comparison Groups
  • Sitaxsentan: Experimental
    Monotherapy arm
    Intervention: Drug: Sitaxsentan
  • Sitaxsentan and Sildenafil: Experimental
    Combination treatment
    Intervention: Drug: Sitaxsentan and Sildenafil

Recruitment Information

Estimated Enrollment  ICMJE180
Estimated Completion DateJanuary 2014
Estimated Primary Completion DateJanuary 2014   (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.
GenderBoth
Ages16 Years to 80 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEUnited States,   Bulgaria,   Chile,   Colombia,   Czech Republic,   Dominican Republic,   India,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Thailand

Administrative Information

NCT ID  ICMJENCT00796510
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study ID Numbers  ICMJEB1321002
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer