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

Last updated: March 4, 2015
Sponsor: Pfizer
Overall Status: Terminated

Phase

3

Condition

High Blood Pressure (Hypertension)

Heart Disease

Scleroderma

Treatment

N/A

Clinical Study ID

NCT00795639
B1321001
  • Ages 16-80
  • All Genders

Study 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

Inclusion Criteria:

  • Current diagnosis of symptomatic pulmonary arterial hypertension (PAH) classified byone of the following: idiopathic arterial hypertension (IPAH), primary pulmonaryhypertension (PPH), familial pulmonary arterial hypertension (FPAH) or pulmonaryarterial hypertension (PAH) associated with connective tissue diseases. Has WHOfunctional class III symptoms.

Exclusion

Exclusion Criteria:

  • Previous exposure to an endothelin receptor antagonist (ETRA) such as sitaxsentan,bosentan or ambrisentan.

Study Design

Total Participants: 183
Study Start date:
December 01, 2008
Estimated Completion Date:
March 31, 2011

Connect with a study center

  • Pfizer Investigational Site

    Buenos Aires, C1428DCO
    Argentina

    Site Not Available

  • Pfizer Investigational Site

    Sofia, 1202
    Bulgaria

    Site Not Available

  • Pfizer Investigational Site

    Veliko Turnovo, 5000
    Bulgaria

    Site Not Available

  • Pfizer Investigational Site

    Temuco, 4781173
    Chile

    Site Not Available

  • Pfizer Investigational Site

    Changsha, Hunan 410008
    China

    Site Not Available

  • Pfizer Investigational Site

    Xi'an, Shanxi 710032
    China

    Site Not Available

  • Pfizer Investigational Site

    Beijing, 100032
    China

    Site Not Available

  • Pfizer Investigational Site

    Shanghai, 200433
    China

    Site Not Available

  • Pfizer Investigational Site

    Bogotá, Cundinamarca
    Colombia

    Site Not Available

  • Pfizer Investigational Site

    Bogotá, Cundinamarca
    Colombia

    Site Not Available

  • Pfizer Investigational Site

    Escazu, San Jose 00000
    Costa Rica

    Site Not Available

  • Pfizer Investigational Site

    Praha 2, 128 08
    Czech Republic

    Site Not Available

  • Pfizer Investigational Site

    Santo Domingo, República Dominicana 00000
    Dominican Republic

    Site Not Available

  • Pfizer Investigational Site

    Guatemala,
    Guatemala

    Site Not Available

  • Pfizer Investigational Site

    Hyderabad, Andhra Pradesh 500 001
    India

    Site Not Available

  • Pfizer Investigational Site

    Ahmedabad, Gujarat 380 060
    India

    Site Not Available

  • Pfizer Investigational Site

    Surat, Gujarat 395 007
    India

    Site Not Available

  • Pfizer Investigational Site

    Vadodara, Gujarat 390 015
    India

    Site Not Available

  • Pfizer Investigational Site

    Pune, Maharashtra 411 030
    India

    Site Not Available

  • Pfizer Investigational Site

    Coimbatore, Tamil Nadu 641 014
    India

    Site Not Available

  • Pfizer Investigational Site

    Madurai, Tamil Nadu 625 107
    India

    Site Not Available

  • Pfizer Investigational Site

    Georgetown, Penang 10990
    Malaysia

    Site Not Available

  • Pfizer Investigational Site

    Mexico, DF 14000
    Mexico

    Site Not Available

  • Pfizer Investigational Site

    Monterrey, Nuevo Leon 64718
    Mexico

    Site Not Available

  • Pfizer Investigational Site

    Lima, 13
    Peru

    Site Not Available

  • Pfizer Investigational Site

    Quezon City, 1100
    Philippines

    Site Not Available

  • Pfizer Investigational Site

    Cluj Napoca, 400 001
    Romania

    Site Not Available

  • Pfizer Investigational Site

    Iasi, 700 503
    Romania

    Site Not Available

  • Pfizer Investigational Site

    Moscow, 105077
    Russian Federation

    Site Not Available

  • Pfizer Investigational Site

    Saint-Petersburg, 197341
    Russian Federation

    Site Not Available

  • Pfizer Investigational Site

    Riyadh, 11159
    Saudi Arabia

    Site Not Available

  • Pfizer Investigational Site

    Belgrade, 11000
    Serbia

    Site Not Available

  • Pfizer Investigational Site

    Bratislava, 83348
    Slovakia

    Site Not Available

  • Pfizer Investigational Site

    Cape Town, Western Cape 7531
    South Africa

    Site Not Available

  • Pfizer Investigational Site

    Johannesburg, 2193
    South Africa

    Site Not Available

  • Pfizer Investigational Site

    Stellenbosch, 7600
    South Africa

    Site Not Available

  • Pfizer Investigational Site

    Bangkoknoi, Bangkok 10700
    Thailand

    Site Not Available

  • Pfizer Investigational Site

    Bangkok, 10330
    Thailand

    Site Not Available

  • Pfizer Investigational Site

    Istanbul, Fatih, 34080
    Turkey

    Site Not Available

  • Pfizer Investigational Site

    Kyiv, 03680
    Ukraine

    Site Not Available

  • Pfizer Investigational Site

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Pfizer Investigational Site

    Mather, California 95655
    United States

    Site Not Available

  • Pfizer Investigational Site

    Sacramento, California 95817
    United States

    Site Not Available

  • Pfizer Investigational Site

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Pfizer Investigational Site

    Littleton, Colorado 80120
    United States

    Site Not Available

  • Pfizer Investigational Site

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Pfizer Investigational Site

    Sarasota, Florida 34233
    United States

    Site Not Available

  • Pfizer Investigational Site

    Weston, Florida 33331
    United States

    Site Not Available

  • Pfizer Investigational Site

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Pfizer Investigational Site

    Olathe, Kansas 66061
    United States

    Site Not Available

  • Pfizer Investigational Site

    Towson, Maryland 21204
    United States

    Site Not Available

  • Pfizer Investigational Site

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Pfizer Investigational Site

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • Pfizer Investigational Site

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • Pfizer Investigational Site

    Islandia, New York 11749
    United States

    Site Not Available

  • Pfizer Investigational Site

    Stony Brook, New York 11794
    United States

    Site Not Available

  • Pfizer Investigational Site

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Pfizer Investigational Site

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Pfizer Investigational Site

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Pfizer Investigational Site

    Lancaster, Pennsylvania 17603
    United States

    Site Not Available

  • Pfizer Investigational Site

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Pfizer Investigational Site

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Pfizer Investigational Site

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Pfizer Investigational Site

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Pfizer Investigational Site

    Dallas, Texas 75390
    United States

    Site Not Available

  • Pfizer Investigational Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Pfizer Investigational Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Pfizer Investigational Site

    Temple, Texas 76508
    United States

    Site Not Available

  • Pfizer Investigational Site

    Lynchburg, Virginia 24501
    United States

    Site Not Available

  • Pfizer Investigational Site

    Richmond, Virginia 23225
    United States

    Site Not Available

  • Pfizer Investigational Site

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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