Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil

NCT00796666 | Terminated Phase 3 Results DMC

• 1 other identifier: B1321003
• Study Type: interventional
• Target: 131
• Locations: 18 countries
• Sites: 48

Brief Summary

As monotherapy for pulmonary arterial hypertension (PAH) begins to fail additional therapies are introduced. Although co-administration of sitaxsentan and sildenafil is well tolerated the controlled safety/efficacy database of the combination is limited.

Conditions

Pulmonary Arterial Hypertension; Pulmonary Hypertension

Keywords

endothelin receptor antagonist (ETRA); Sitaxsentan

Outcome Measures

Primary Outcomes (1)

• Time to Clinical Worsening (TTCW)

  Clinical worsening defined as time between first dose of study drug and occurrence of death; or heart-lung/lung transplant; or hospitalization for worsening pulmonary atrial hypertension (PAH); or atrial septostomy; or withdrawal due to addition of chronic medications for treatment of worsening PAH: prostacyclin/prostacyclin analogues/phosphodiesterase-5inhibitors/alternative endothelin receptor antagonists/intravenous inotropes; or increase of calcium channel blockers or oxygen. TTCW measured as duration between study's first dose date in and date when first clinical worsening event occurs.

  Baseline, Weeks 12, 24 or Early Termination (ET)

Secondary Outcomes (12)

• Change From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD)

  Baseline to Weeks 12 and 24

• Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Weeks 12, 24, 48

  Baseline, Weeks 12, 24 or ET

• Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Physical Functioning Domain

  Baseline, Weeks 12, 24 and ET

• Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitations Due to Physical Health Problems Domain

  Baseline, Weeks 12, 24 or ET

• Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Bodily Pain Domain

  Baseline, Weeks 12, 24 or ET

Study Arms (2)

Sitaxsentan and Placebo

EXPERIMENTAL

Monotherapy arm

Drug: Sitaxsentan

Sitaxsentan and Sildenafil

EXPERIMENTAL

Combination treatment

Drug: Sitaxsentan and Sildenafil

Interventions

Sitaxsentan DRUG

Sitaxsentan = 100 mg tablet administered orally, once daily Sildenafil placebo = 1 tablet administered orally, three times a day

Sitaxsentan and Placebo

Sitaxsentan and Sildenafil DRUG

Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day

Sitaxsentan and Sildenafil

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:

• Previously enrolled in B1321001 (NCT00795639) and completed the 12-week study as planned.

You may not qualify if:

• Treated with an investigational drug, other than sitaxsentan sodium in B1321001 (NCT00795639), or device that has not received regulatory approval within the 30 days prior to Baseline/Day 1 or during the study.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (48)

Pfizer Investigational Site

Fountain Valley, California, 92708, United States

Location

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Gainesville, Florida, 32610, United States

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Weston, Florida, 33331, United States

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Boston, Massachusetts, 02111, United States

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Omaha, Nebraska, 68131, 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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Providence, Rhode Island, 02903, 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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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, 1233, Bulgaria

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Temuco, 4781173, Chile

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Changsha, Hunan, 410008, 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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Prague, 128 08, Czechia

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Hyderabad, Andhra Pradesh, 500 001, India

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Hyderabad, Andhra Pradesh, 500 063, India

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Ahmedabad, Gujarat, 380 015, 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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Monterrey, Nuevo León, 64718, Mexico

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Lima, 32, Peru

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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, 194156, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 197341, Russia

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Belgrade, 11000, Serbia

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Johannesburg, 2193, South Africa

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Bangkoknoi, Bangkok, 10700, Thailand

Location

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Istanbul, Fatih, 34080, Turkey (Türkiye)

Location

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Kyiv, 03680, Ukraine

Location

Pfizer Investigational Site

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; Sildenafil Citrate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Study terminated early by sponsor, no Week 48 information collected.

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 24, 2008
• Study Start: May 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 24, 2015
• Results First Posted: February 29, 2012

Record last verified: 2015-03

Locations

ME (1); ZA (1); US (12); CO (1); TH (1); CL (1); MY (1); CN (4); PE (1); RO (2); AR (4); BU (1); CZ (1); TU (1); RU (4); SE (1); IN (9); UA (2)