SR-PAAS - Sitaxentan Efficacy and Safety Trial With a Randomized Prospective Assessment of Adding Sildenafil 


Tracking Information

Start Date  ICMJENovember 2008
Estimated Primary Completion DateFebruary 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2008)		The primary efficacy endpoint is the to evaluate change in the 6MWD. [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00795639 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: November 20, 2008)		To evaluate the safety and efficacy of sitaxsentan (100 mg dose) as compared to placebo in the treatment of subjects with PAH by determining change from Baseline in WHO functional class and time to clinical worsening. [ Time Frame: Baseline/Day 1 and Weeks 4, 8 and 12 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJESR-PAAS - Sitaxentan Efficacy and Safety Trial With a Randomized Prospective Assessment of Adding Sildenafil
Official Title  ICMJEA Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety And Efficacy Study Of Sitaxsentan Sodium In Subjects With Pulmonary Arterial Hypertension.
Brief Summary

This protocol is for subjects with pulmonary arterial hypertension and is the first of 3 studies forming the SR-PAAS program.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • PAH
  • Pulmonary Arterial Hypertension
  • Pulmonary Hypertension
  • Sitaxsentan
  • ETRA
Intervention  ICMJE
  • Drug: Sitaxsentan
    Sitaxsentan = 100 mg tablet administered orally, once daily
    Other Name: Sitaxsentan
  • Drug: Placebo
    Sitaxsentan Placebo = 1 tablet administered orally, once daily
    Other Name: Sitaxsentan Placebo
Study Arms / Comparison Groups
  • Sitaxsentan: Experimental
    Monotherapy
    Intervention: Drug: Sitaxsentan
  • Sitaxsentan Placebo: Placebo Comparator
    Monotherapy
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE180
Estimated Completion DateFebruary 2011
Estimated Primary Completion DateFebruary 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Current diagnosis of symptomatic PAH classified by one of the following: IPAH, PPH, FPAH or PAH associated with connective tissue diseases. Has WHO functional class III symptoms.

Exclusion Criteria:

  • Previous exposure to an endothelin receptor antagonist (ETRA) such as sitaxsentan, bosentan or ambrisentan.
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  ICMJENCT00795639
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study ID Numbers  ICMJEB1321001
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer