Clinical trial NCT00795639: Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)
Official title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety And Efficacy Study Of Sitaxsentan Sodium In Subjects With Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Pulmonary Hypertension
Keywords: Sitaxsentan
endothelin receptor antagonist
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-21
Enrollment: 183
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: This protocol is for subjects with pulmonary arterial hypertension and is the first of 3 studies forming the Sitaxsentan efficacy and safety trial with Randomized Prospective Assessment of Adding Sildenafil (SR-PAAS) program.


Eligibility criteria: Inclusion Criteria:

* Current diagnosis of symptomatic pulmonary arterial hypertension (PAH) classified by one of the following: idiopathic arterial hypertension (IPAH), primary pulmonary hypertension (PPH), familial pulmonary arterial hypertension (FPAH) or pulmonary arterial hypertension (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.

Primary outcomes:
measure: Change From Baseline in Total Distance Walked During 6 Minute Walk Distance (6MWD) at Week 12
timeFrame: Baseline/Day 1 and Week 12
Secondary outcomes:
measure: Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12
timeFrame: Baseline, Weeks 4, 8 and 12 or Early Termination (ET)
measure: Time to Clinical Worsening (TTCW)
timeFrame: Baseline, Weeks 4, 8 and 12 or ET
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Pfizer Investigational Site
state: California
city: Mather
country: United States
facility: Pfizer Investigational Site
state: California
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: Englewood
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Littleton
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Weston
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Olathe
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Towson
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: New Brunswick
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Islandia
country: United States
facility: Pfizer Investigational Site
state: New York
city: Stony Brook
country: United States
facility: Pfizer Investigational Site
state: New York
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: Lancaster
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Lancaster
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Temple
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Lynchburg
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
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: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Veliko Turnovo
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: Xi'an
country: China
facility: Pfizer Investigational Site
state: Shanxi
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: Escazu
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
city: Praha 2
country: Czech Republic
facility: Pfizer Investigational Site
city: Santo Domingo
country: Dominican Republic
facility: Pfizer Investigational Site
state: República Dominicana
city: Santo Domingo
country: Dominican Republic
facility: Pfizer Investigational Site
city: Guatemala
country: Guatemala
facility: Pfizer Investigational Site
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andhera Pradesh
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
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: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
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: Saint-Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Pfizer Investigational Site
city: Belgrade
country: Serbia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
state: Western Cape
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
city: Stellenbosch
country: South Africa
facility: Pfizer Investigational Site
city: Bangkoknoi
country: Thailand
facility: Pfizer Investigational Site
state: Bangkok
city: Bangkok
country: Thailand
facility: Pfizer Investigational Site
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: