Back to resultsSitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)
Primary Purpose
Pulmonary Arterial Hypertension, Pulmonary Hypertension
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sitaxsentan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Sitaxsentan, endothelin receptor antagonist
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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
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- Pfizer Investigational Site
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sitaxsentan
Sitaxsentan Placebo
Arm Description
Monotherapy
Monotherapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00795639
Brief Title
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
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension, Pulmonary Hypertension
Keywords
Sitaxsentan, endothelin receptor antagonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
183 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sitaxsentan
Arm Type
Experimental
Arm Description
Monotherapy
Arm Title
Sitaxsentan Placebo
Arm Type
Placebo Comparator
Arm Description
Monotherapy
Intervention Type
Drug
Intervention Name(s)
Sitaxsentan
Intervention Description
Sitaxsentan = 100 mg tablet administered orally, once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sitaxsentan Placebo
Intervention Description
Sitaxsentan Placebo = 1 tablet administered orally, once daily
Primary Outcome Measure Information:
Title
Change From Baseline in Total Distance Walked During 6 Minute Walk Distance (6MWD) at Week 12
Description
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.
Time Frame
Baseline/Day 1 and Week 12
Secondary Outcome Measure Information:
Title
Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12
Description
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.
Time Frame
Baseline, Weeks 4, 8 and 12 or Early Termination (ET)
Title
Time to Clinical Worsening (TTCW)
Description
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.
Time Frame
Baseline, Weeks 4, 8 and 12 or ET
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Pfizer Investigational Site
City
Mather
State/Province
California
ZIP/Postal Code
95655
Country
United States
Facility Name
Pfizer Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Pfizer Investigational Site
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Pfizer Investigational Site
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Pfizer Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Pfizer Investigational Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Pfizer Investigational Site
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Pfizer Investigational Site
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66061
Country
United States
Facility Name
Pfizer Investigational Site
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Pfizer Investigational Site
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Pfizer Investigational Site
City
Islandia
State/Province
New York
ZIP/Postal Code
11749
Country
United States
Facility Name
Pfizer Investigational Site
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Pfizer Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Pfizer Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Pfizer Investigational Site
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Facility Name
Pfizer Investigational Site
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17603
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Pfizer Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Pfizer Investigational Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Pfizer Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Pfizer Investigational Site
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Pfizer Investigational Site
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Pfizer Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1039AAO
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1428DCO
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1428DUS
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Veliko Turnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Temuco
ZIP/Postal Code
4781173
Country
Chile
Facility Name
Pfizer Investigational Site
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Pfizer Investigational Site
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Facility Name
Pfizer Investigational Site
City
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Pfizer Investigational Site
City
Bogotá
State/Province
Cundinamarca
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Escazu
State/Province
San Jose
ZIP/Postal Code
00000
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Praha 2
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Santo Domingo
State/Province
República Dominicana
ZIP/Postal Code
00000
Country
Dominican Republic
Facility Name
Pfizer Investigational Site
City
Santo Domingo
ZIP/Postal Code
4966
Country
Dominican Republic
Facility Name
Pfizer Investigational Site
City
Guatemala
Country
Guatemala
Facility Name
Pfizer Investigational Site
City
Hyderabad
State/Province
Andhera Pradesh
ZIP/Postal Code
500 063
Country
India
Facility Name
Pfizer Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 001
Country
India
Facility Name
Pfizer Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380 060
Country
India
Facility Name
Pfizer Investigational Site
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395 007
Country
India
Facility Name
Pfizer Investigational Site
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390 015
Country
India
Facility Name
Pfizer Investigational Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 030
Country
India
Facility Name
Pfizer Investigational Site
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641 014
Country
India
Facility Name
Pfizer Investigational Site
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625 107
Country
India
Facility Name
Pfizer Investigational Site
City
Georgetown
State/Province
Penang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Mexico
State/Province
DF
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Mexico
State/Province
DF
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64718
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
13
Country
Peru
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
32
Country
Peru
Facility Name
Pfizer Investigational Site
City
Quezon City
ZIP/Postal Code
1100
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Cluj Napoca
ZIP/Postal Code
400 001
Country
Romania
Facility Name
Pfizer Investigational Site
City
Iasi
ZIP/Postal Code
700 503
Country
Romania
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
194156
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Riyadh
ZIP/Postal Code
11159
Country
Saudi Arabia
Facility Name
Pfizer Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
83348
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7531
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Stellenbosch
ZIP/Postal Code
7600
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Istanbul, Fatih
ZIP/Postal Code
34080
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kyiv
Country
Ukraine
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1321001&StudyName=Sitaxsentan%20Efficacy%20And%20Safety%20Trial%20With%20A%20Randomized%20Prospective%20Assessment%20Of%20Adding%20Sildenafil%20%28SR-PAAS%29
Description
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Learn more about this trial
Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)
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