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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00795639
Recruitment Status : Terminated (Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.)
First Posted : November 21, 2008
Results First Posted : March 1, 2012
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Pulmonary Hypertension Drug: Sitaxsentan Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011


Arm Intervention/treatment
Experimental: Sitaxsentan
Monotherapy
Drug: Sitaxsentan
Sitaxsentan = 100 mg tablet administered orally, once daily

Placebo Comparator: Sitaxsentan Placebo
Monotherapy
Drug: Placebo
Sitaxsentan Placebo = 1 tablet administered orally, once daily
Other Name: Sitaxsentan Placebo




Primary Outcome Measures :
  1. Change From Baseline in Total Distance Walked During 6 Minute Walk Distance (6MWD) at Week 12 [ Time Frame: Baseline/Day 1 and 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 :
  1. Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12 [ Time Frame: Baseline, Weeks 4, 8 and 12 or Early Termination (ET) ]
    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.

  2. Time to Clinical Worsening (TTCW) [ Time Frame: Baseline, Weeks 4, 8 and 12 or ET ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795639


Locations
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United States, California
Pfizer Investigational Site
Fountain Valley, California, United States, 92708
Pfizer Investigational Site
Mather, California, United States, 95655
Pfizer Investigational Site
Sacramento, California, United States, 95817
United States, Colorado
Pfizer Investigational Site
Englewood, Colorado, United States, 80113
Pfizer Investigational Site
Littleton, Colorado, United States, 80120
United States, Florida
Pfizer Investigational Site
Gainesville, Florida, United States, 32610
Pfizer Investigational Site
Sarasota, Florida, United States, 34233
Pfizer Investigational Site
Weston, Florida, United States, 33331
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60612
United States, Kansas
Pfizer Investigational Site
Olathe, Kansas, United States, 66061
United States, Maryland
Pfizer Investigational Site
Towson, Maryland, United States, 21204
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02111
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68131
United States, New Jersey
Pfizer Investigational Site
New Brunswick, New Jersey, United States, 08903
United States, New York
Pfizer Investigational Site
Islandia, New York, United States, 11749
Pfizer Investigational Site
Stony Brook, New York, United States, 11794
United States, North Carolina
Pfizer Investigational Site
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45219
Pfizer Investigational Site
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Pfizer Investigational Site
Lancaster, Pennsylvania, United States, 17602
Pfizer Investigational Site
Lancaster, Pennsylvania, United States, 17603
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
United States, Rhode Island
Pfizer Investigational Site
Providence, Rhode Island, United States, 02903
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29425
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75390
Pfizer Investigational Site
Houston, Texas, United States, 77030
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Pfizer Investigational Site
Temple, Texas, United States, 76508
United States, Virginia
Pfizer Investigational Site
Lynchburg, Virginia, United States, 24501
Pfizer Investigational Site
Richmond, Virginia, United States, 23225
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53215
Argentina
Pfizer Investigational Site
Buenos Aires, Argentina, C1039AAO
Pfizer Investigational Site
Buenos Aires, Argentina, C1428DCO
Pfizer Investigational Site
Buenos Aires, Argentina, C1428DUS
Pfizer Investigational Site
Buenos Aires, Argentina, C1431FWO
Bulgaria
Pfizer Investigational Site
Sofia, Bulgaria, 1202
Pfizer Investigational Site
Sofia, Bulgaria, 1233
Pfizer Investigational Site
Veliko Turnovo, Bulgaria, 5000
Chile
Pfizer Investigational Site
Temuco, Chile, 4781173
China, Hunan
Pfizer Investigational Site
Changsha, Hunan, China, 410008
China, Shanxi
Pfizer Investigational Site
Xi'an, Shanxi, China, 710032
China
Pfizer Investigational Site
Beijing, China, 100032
Pfizer Investigational Site
Shanghai, China, 200001
Pfizer Investigational Site
Shanghai, China, 200433
Colombia
Pfizer Investigational Site
Bogotá, Cundinamarca, Colombia
Costa Rica
Pfizer Investigational Site
Escazu, San Jose, Costa Rica, 00000
Czech Republic
Pfizer Investigational Site
Praha 2, Czech Republic, 128 08
Dominican Republic
Pfizer Investigational Site
Santo Domingo, República Dominicana, Dominican Republic, 00000
Pfizer Investigational Site
Santo Domingo, Dominican Republic, 4966
Guatemala
Pfizer Investigational Site
Guatemala, Guatemala
India
Pfizer Investigational Site
Hyderabad, Andhera Pradesh, India, 500 063
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India, 500 001
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 060
Pfizer Investigational Site
Surat, Gujarat, India, 395 007
Pfizer Investigational Site
Vadodara, Gujarat, India, 390 015
Pfizer Investigational Site
Pune, Maharashtra, India, 411 030
Pfizer Investigational Site
Coimbatore, Tamil Nadu, India, 641 014
Pfizer Investigational Site
Madurai, Tamil Nadu, India, 625 107
Malaysia
Pfizer Investigational Site
Georgetown, Penang, Malaysia, 10990
Mexico
Pfizer Investigational Site
Mexico, DF, Mexico, 14000
Pfizer Investigational Site
Mexico, DF, Mexico, 14080
Pfizer Investigational Site
Monterrey, Nuevo Leon, Mexico, 64718
Peru
Pfizer Investigational Site
Lima, Peru, 13
Pfizer Investigational Site
Lima, Peru, 32
Philippines
Pfizer Investigational Site
Quezon City, Philippines, 1100
Romania
Pfizer Investigational Site
Cluj Napoca, Romania, 400 001
Pfizer Investigational Site
Iasi, Romania, 700 503
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 105077
Pfizer Investigational Site
Moscow, Russian Federation, 121552
Pfizer Investigational Site
Saint-Petersburg, Russian Federation, 194156
Pfizer Investigational Site
Saint-Petersburg, Russian Federation, 197022
Pfizer Investigational Site
Saint-Petersburg, Russian Federation, 197341
Saudi Arabia
Pfizer Investigational Site
Riyadh, Saudi Arabia, 11159
Serbia
Pfizer Investigational Site
Belgrade, Serbia, 11000
Slovakia
Pfizer Investigational Site
Bratislava, Slovakia, 83348
South Africa
Pfizer Investigational Site
Cape Town, Western Cape, South Africa, 7531
Pfizer Investigational Site
Cape Town, South Africa, 7500
Pfizer Investigational Site
Johannesburg, South Africa, 2193
Pfizer Investigational Site
Stellenbosch, South Africa, 7600
Thailand
Pfizer Investigational Site
Bangkoknoi, Bangkok, Thailand, 10700
Pfizer Investigational Site
Bangkok, Thailand, 10330
Turkey
Pfizer Investigational Site
Istanbul, Fatih, Turkey, 34080
Ukraine
Pfizer Investigational Site
Kyiv, Ukraine, 03680
Pfizer Investigational Site
Kyiv, Ukraine
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00795639    
Other Study ID Numbers: B1321001
First Posted: November 21, 2008    Key Record Dates
Results First Posted: March 1, 2012
Last Update Posted: March 24, 2015
Last Verified: March 2015
Keywords provided by Pfizer:
Sitaxsentan
endothelin receptor antagonist
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Sitaxsentan
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action