Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxentan Efficacy and Safety Trial With a Randomized Prospective Assessment of Adding Sildenafil


Tracking Information

Start Date  ICMJEMarch 2009
Estimated Primary Completion DateJanuary 2012   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: November 9, 2009)		The primary objective is to evaluate the efficacy of sitaxsentan plus sildenafil as compared to sitaxsentan monotherapy by determining time to clinical worsening in the treatment of subjects with PAH who have completed Study B1321001. [ Time Frame: Duration of the study. ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures  ICMJE 
 (submitted: November 20, 2008)		The primary objective is to evaluate the efficacy of sitaxsentan plus sildenafil as compared to sitaxsentan monotherapy by determining time to clinical worsening in the treatment of subjects with PAH who have completed Study B1321001. [ Time Frame: Throughout ] [ Designated as safety issue: Yes ]
Change HistoryComplete list of historical versions of study NCT00796666 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: November 20, 2008)		The secondary objective is to evaluate the safety and efficacy of sitaxsentan plus sildenafil as compared to sitaxsentan monotherapy who have completed Study B1321001 by change in 6-Minute Walk Distance, WHO functional class, and SF-36 Health Survey. [ Time Frame: Baseline/Day 1 to Weeks 12, 24, and 48 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEStudy Looking at Combination Therapy (Sitaxsentan+Sildenafil) vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxentan Efficacy and Safety Trial With a Randomized Prospective Assessment of Adding Sildenafil
Official Title  ICMJEA Phase 3, Multi-Center, Randomized, Double-Blind, Efficacy And Safety Study Of Monotherapy Sitaxsentan Sodium Versus Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension Who Have Completed Study B1321001.
Brief Summary

As monotherapy for PAH begins to fail additional therapies are introduced. although co-administration of sitaxsentan and sildenafil is wel tolerated the controlled safety/efficacy database of the combination is limited.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Pulmonary Arterial Hypertension
  • Pulmonary Hypertension
  • ETRA
  • PAH
Intervention  ICMJE
  • Drug: Sitaxsentan
    Sitaxsentan = 100 mg tablet administered orally, once daily Sildenafil placebo = 1 tablet administered orally, three times a day
    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 and Placebo: 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 2012
Estimated Primary Completion DateJanuary 2012   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Previously enrolled in B1321001 and completed the 12-week study as planned.

Exclusion Criteria:

  • Treated with an investigational drug, other than sitaxsentan sodium in B1321001, 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  ICMJENCT00796666
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study ID Numbers  ICMJEB1321003
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer