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

NCT00795639 | Terminated Phase 3 Results DMC

• 1 other identifier: B1321001
• Study Type: interventional
• Target: 183
• Locations: 23 countries
• Sites: 84

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.

Conditions

Pulmonary Arterial Hypertension; Pulmonary Hypertension

Keywords

Sitaxsentan; endothelin receptor antagonist

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12

  Baseline, Weeks 4, 8 and 12 or Early Termination (ET)

• Time to Clinical Worsening (TTCW)

  Baseline, Weeks 4, 8 and 12 or ET

Study Arms (2)

Sitaxsentan

EXPERIMENTAL

Monotherapy

Drug: Sitaxsentan

Sitaxsentan Placebo

PLACEBO COMPARATOR

Monotherapy

Drug: Placebo

Interventions

Sitaxsentan DRUG

Sitaxsentan = 100 mg tablet administered orally, once daily

Sitaxsentan

Placebo DRUG

Sitaxsentan Placebo = 1 tablet administered orally, once daily

Also known as: Sitaxsentan Placebo

Sitaxsentan Placebo

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (85)

Pfizer Investigational Site

Fountain Valley, California, 92708, United States

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Mather, California, 95655, United States

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Sacramento, California, 95817, United States

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Englewood, Colorado, 80113, United States

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Littleton, Colorado, 80120, United States

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Gainesville, Florida, 32610, United States

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Sarasota, Florida, 34233, United States

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Weston, Florida, 33331, United States

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Chicago, Illinois, 60612, United States

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Olathe, Kansas, 66061, United States

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Towson, Maryland, 21204, United States

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Boston, Massachusetts, 02111, United States

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Omaha, Nebraska, 68131, United States

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New Brunswick, New Jersey, 08903, United States

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Islandia, New York, 11749, United States

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Stony Brook, New York, 11794, United States

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Chapel Hill, North Carolina, 27599, United States

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Cincinnati, Ohio, 45219, United States

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Cleveland, Ohio, 44106, United States

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Lancaster, Pennsylvania, 17602, United States

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Lancaster, Pennsylvania, 17603, United States

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Philadelphia, Pennsylvania, 19140, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Providence, Rhode Island, 02903, United States

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Charleston, South Carolina, 29425, United States

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Dallas, Texas, 75390, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78229, United States

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Temple, Texas, 76508, United States

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Lynchburg, Virginia, 24501, United States

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Richmond, Virginia, 23225, United States

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Milwaukee, Wisconsin, 53215, United States

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Buenos Aires, C1039AAO, Argentina

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Buenos Aires, C1428DCO, Argentina

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Buenos Aires, C1428DUS, Argentina

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Buenos Aires, C1431FWO, Argentina

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Sofia, 1202, Bulgaria

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Sofia, 1233, Bulgaria

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Veliko Tarnovo, 5000, Bulgaria

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Temuco, 4781173, Chile

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Changsha, Hunan, 410008, China

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Xi’an, Shanxi, 710032, China

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Beijing, 100032, China

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Shanghai, 200001, China

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Shanghai, 200433, China

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Bogotá, Cundinamarca, Colombia

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Escazú, Provincia de San José, 00000, Costa Rica

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Prague, 128 08, Czechia

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Santo Domingo, República Dominicana, 00000, Dominican Republic

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Santo Domingo, Santo Domingo Province, 4966, Dominican Republic

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Guatemala City, Departamento de Guatemala, Guatemala

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Hyderabad, Andhera Pradesh, 500 063, India

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Hyderabad, Andhra Pradesh, 500 001, India

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Ahmedabad, Gujarat, 380 060, India

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Surat, Gujarat, 395 007, India

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Vadodara, Gujarat, 390 015, India

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Pune, Maharashtra, 411 030, India

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Coimbatore, Tamil Nadu, 641 014, India

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Madurai, Tamil Nadu, 625 107, India

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George Town, Pulau Pinang, 10990, Malaysia

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Mexico City, Mexico City, 14000, Mexico

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Mexico City, Mexico City, 14080, Mexico

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Monterrey, Nuevo León, 64718, Mexico

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Lima, 13, Peru

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Lima, 32, Peru

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Quezon City, 1100, Philippines

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Cluj-Napoca, Romania, 400 001, Romania

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Iași, 700 503, Romania

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Moscow, 105077, Russia

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Moscow, 121552, Russia

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Saint Petersburg, 194156, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 197341, Russia

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Riyadh, 11159, Saudi Arabia

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Belgrade, 11000, Serbia

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Bratislava, 83348, Slovakia

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Cape Town, Western Cape, 7531, South Africa

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Cape Town, 7500, South Africa

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Johannesburg, 2193, South Africa

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Stellenbosch, 7600, South Africa

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Bangkoknoi, Bangkok, 10700, Thailand

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Bangkok, 10330, Thailand

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Istanbul, Fatih, 34080, Turkey (Türkiye)

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Kyiv, 03680, Ukraine

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Kyiv, Ukraine

Location

Related Links

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

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension, Pulmonary

Interventions

sitaxsentan

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Study terminated early.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 21, 2008
• Study Start: December 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 24, 2015
• Results First Posted: March 1, 2012

Record last verified: 2015-03

Locations

CN (5); MY (1); PE (2); GU (1); SL (1); IN (8); UA (2); BU (3); AR (4); RO (2); CZ (1); DO (2); ZA (4); US (32); SE (1); CO (1); PH (1); ME (3); TH (2); CL (1); TU (1); SA (1); RU (5)