Clinical trial NCT00796666: Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil
Official title: A 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 (NCT00795639)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Pulmonary Hypertension
Keywords: endothelin receptor antagonist (ETRA)
Sitaxsentan
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-24
Enrollment: 131
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As monotherapy for pulmonary arterial hypertension (PAH) begins to fail additional therapies are introduced. Although co-administration of sitaxsentan and sildenafil is well tolerated the controlled safety/efficacy database of the combination is limited.


Eligibility criteria: Inclusion Criteria:

* Previously enrolled in B1321001 (NCT00795639) and completed the 12-week study as planned.

Exclusion Criteria:

* Treated with an investigational drug, other than sitaxsentan sodium in B1321001 (NCT00795639), or device that has not received regulatory approval within the 30 days prior to Baseline/Day 1 or during the study.

Primary outcomes:
measure: Time to Clinical Worsening (TTCW)
timeFrame: Baseline, Weeks 12, 24 or Early Termination (ET)
Secondary outcomes:
measure: Change From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD)
timeFrame: Baseline to Weeks 12 and 24
measure: Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Weeks 12, 24, 48
timeFrame: Baseline, Weeks 12, 24 or ET
measure: Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Physical Functioning Domain
timeFrame: Baseline, Weeks 12, 24 and ET
measure: Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitations Due to Physical Health Problems Domain
timeFrame: Baseline, Weeks 12, 24 or ET
measure: Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Bodily Pain Domain
timeFrame: Baseline, Weeks 12, 24 or ET
measure: Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - General Health Domain
timeFrame: Baseline, Weeks 12, 24 or ET
measure: Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Vitality Domain
timeFrame: Baseline, Weeks 12, 24 or ET
measure: Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Social Functioning Domain
timeFrame: Baseline, Weeks 12, 24 or ET
measure: Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitation Due to Emotional Problems Domain
timeFrame: Baseline, Weeks 12, 24 or ET
measure: Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Mental Health Domain
timeFrame: Baseline, Weeks 12, 24 or ET
measure: Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Mental Health
timeFrame: Baseline, Weeks 12, 24 or ET
measure: Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Physical Health
timeFrame: Baseline, Weeks 12, 24 or ET
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Pfizer Investigational Site
state: California
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Weston
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Chapel Hill
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Providence
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Temuco
country: Chile
facility: Pfizer Investigational Site
city: Changsha
country: China
facility: Pfizer Investigational Site
state: Hunan
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Bogotá
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Praha 2
country: Czech Republic
facility: Pfizer Investigational Site
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Surat
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Vadodara
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Coimbatore
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Madurai
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Georgetown
country: Malaysia
facility: Pfizer Investigational Site
state: Penang
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Cluj Napoca
country: Romania
facility: Pfizer Investigational Site
city: Iasi
country: Romania
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Belgrade
country: Serbia
facility: Pfizer Investigational Site
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
city: Bangkoknoi
country: Thailand
facility: Pfizer Investigational Site
state: Bangkok
city: Istanbul, Fatih
country: Turkey
facility: Pfizer Investigational Site
city: Kyiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kyiv
country: Ukraine
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: