Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)

Pulmonary Hypertension Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00795639
• Other study ID #: B1321001
• Status: Terminated
• Phase: Phase 3
• First received: November 20, 2008
• Last updated: March 4, 2015
• Start date: December 2008
• Est. completion date: March 2011

Study information

• Verified date: March 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 183
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension
• Pulmonary Hypertension

Intervention

Drug:
• Sitaxsentan
Sitaxsentan = 100 mg tablet administered orally, once daily
• Placebo
Sitaxsentan Placebo = 1 tablet administered orally, once daily

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Buenos Aires
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Veliko Turnovo
Chile	Pfizer Investigational Site	Temuco
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Changsha	Hunan
China	Pfizer Investigational Site	Shanghai
China	Pfizer Investigational Site	Shanghai
China	Pfizer Investigational Site	Xi'an	Shanxi
Colombia	Pfizer Investigational Site	Bogotá	Cundinamarca
Costa Rica	Pfizer Investigational Site	Escazu	San Jose
Czech Republic	Pfizer Investigational Site	Praha 2
Dominican Republic	Pfizer Investigational Site	Santo Domingo	República Dominicana
Dominican Republic	Pfizer Investigational Site	Santo Domingo
Guatemala	Pfizer Investigational Site	Guatemala
India	Pfizer Investigational Site	Ahmedabad	Gujarat
India	Pfizer Investigational Site	Coimbatore	Tamil Nadu
India	Pfizer Investigational Site	Hyderabad	Andhera Pradesh
India	Pfizer Investigational Site	Hyderabad	Andhra Pradesh
India	Pfizer Investigational Site	Madurai	Tamil Nadu
India	Pfizer Investigational Site	Pune	Maharashtra
India	Pfizer Investigational Site	Surat	Gujarat
India	Pfizer Investigational Site	Vadodara	Gujarat
Malaysia	Pfizer Investigational Site	Georgetown	Penang
Mexico	Pfizer Investigational Site	Mexico	DF
Mexico	Pfizer Investigational Site	Mexico	DF
Mexico	Pfizer Investigational Site	Monterrey	Nuevo Leon
Peru	Pfizer Investigational Site	Lima
Peru	Pfizer Investigational Site	Lima
Philippines	Pfizer Investigational Site	Quezon City
Romania	Pfizer Investigational Site	Cluj Napoca
Romania	Pfizer Investigational Site	Iasi
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Saint-Petersburg
Russian Federation	Pfizer Investigational Site	Saint-Petersburg
Russian Federation	Pfizer Investigational Site	Saint-Petersburg
Saudi Arabia	Pfizer Investigational Site	Riyadh
Serbia	Pfizer Investigational Site	Belgrade
Slovakia	Pfizer Investigational Site	Bratislava
South Africa	Pfizer Investigational Site	Cape Town	Western Cape
South Africa	Pfizer Investigational Site	Cape Town
South Africa	Pfizer Investigational Site	Johannesburg
South Africa	Pfizer Investigational Site	Stellenbosch
Thailand	Pfizer Investigational Site	Bangkok
Thailand	Pfizer Investigational Site	Bangkoknoi	Bangkok
Turkey	Pfizer Investigational Site	Istanbul, Fatih
Ukraine	Pfizer Investigational Site	Kyiv
Ukraine	Pfizer Investigational Site	Kyiv
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Chapel Hill	North Carolina
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Englewood	Colorado
United States	Pfizer Investigational Site	Fountain Valley	California
United States	Pfizer Investigational Site	Gainesville	Florida
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Islandia	New York
United States	Pfizer Investigational Site	Lancaster	Pennsylvania
United States	Pfizer Investigational Site	Lancaster	Pennsylvania
United States	Pfizer Investigational Site	Littleton	Colorado
United States	Pfizer Investigational Site	Lynchburg	Virginia
United States	Pfizer Investigational Site	Mather	California
United States	Pfizer Investigational Site	Milwaukee	Wisconsin
United States	Pfizer Investigational Site	New Brunswick	New Jersey
United States	Pfizer Investigational Site	Olathe	Kansas
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Providence	Rhode Island
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Sacramento	California
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	Sarasota	Florida
United States	Pfizer Investigational Site	Stony Brook	New York
United States	Pfizer Investigational Site	Temple	Texas
United States	Pfizer Investigational Site	Towson	Maryland
United States	Pfizer Investigational Site	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Chile,  China,  Colombia,  Costa Rica,  Czech Republic,  Dominican Republic,  Guatemala,  India,  Malaysia,  Mexico,  Peru,  Philippines,  Romania,  Russian Federation,  Saudi Arabia,  Serbia,  Slovakia,  South Africa,  Thailand,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Total Distance Walked During 6 Minute Walk Distance (6MWD) at Week 12	6 MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. Change is Week 12 results minus baseline results.	Baseline/Day 1 and Week 12	Yes
Secondary	Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12	WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Improvement = reduction in functional class, deterioration = increase in functional class, no change = no change in functional class.	Baseline, Weeks 4, 8 and 12 or Early Termination (ET)	Yes
Secondary	Time to Clinical Worsening (TTCW)	TTCW defined as the number of days between first dose of study drug and the occurrence of a predefined clinical worsening event. Predefined clinical worsening events included: hospitalization for worsening PAH, on-study death, heart-lung or lung transplant, atrial septostomy or withdrawal due to the addition of any chronic medications for the treatment of worsening PAH.	Baseline, Weeks 4, 8 and 12 or ET	No

External Links

•   To obtain contact information for a study center near you, click here.