A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension

NCT00811018 | Terminated Phase 3 Results

• 2 other identifiers: B1321007FPH03
• Study Type: interventional
• Target: 1,192
• Locations: 15 countries
• Sites: 87

Brief Summary

This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH until sitaxsentan, in a particular country or region, is commercially available for the treatment of PAH or the study is closed.

Conditions

Pulmonary Arterial Hypertension

Keywords

Open-label study

Outcome Measures

Primary Outcomes (13)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.

  Day 1 up to 82 months

• The Percentage of Participants Who Experience an Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Value Greater Than (>) 3.0 Times (x) the Upper Limit of Normal Range (ULN)

  ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

  Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months

• The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN

  ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

  Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months

• Percentage of Participants With Total Bilirubin > 1.5 x ULN

  Total builirubin data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

  Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months

• Percentage of Participants With Laboratory Test Abnormalities (Hematology)

  Hematology data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

  Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months

• Percentage of Participants With Laboratory Test Abnormalities (Chemistry)

  Chemistry data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

  Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months

• Percentage of Participants With Laboratory Test Abnormalities (Urinalysis)

  Urinalysis data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

  Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months

• Percentage of Participants With Anticoagulant Use

  Participants with anticoagulant use before first dose or participants with anticoagulant use from first dose of sitaxsentan.

  Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months

• Percentage of Participants With Elevated International Normalize Ratio (INR)

  Elevated INR in participants who took warfarin, warfarin derivatives, other anticoagulant and no anticoagulants. Elevated INR defined as \> 3.5. Percentage calculated using number of participants with INR data as the denominator.

  Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months

• Percentage of Participants With Electrocardiography (ECG) Results of Potential Clinical Importance

  Standard 12-lead ECG results determined to be of potential clinical importance according to investigator clinical judgement.

  Weeks 28,60,72,84,96,104, Transition Visit up to 82 months

• Percentage of Participants With Vital Sign Results of Potential Clinical Importance

  Vital signs include sitting blood pressure, respiration rate, heart rate and temperature. Potential clinical importance determined according to investigator clinical judgement.

  Day 1, Weeks 28,60,72,84,96,104, Transition visit, every 6 months Post Transition, up to 82 months

• Percentage of Participants With Abnormal Prothrombin Time (PT)

  PT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

  Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months

• Percentage of Participants With Abnormal Partial Thromboplastin Time (PTT)

  PTT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

  Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months

Study Arms (1)

Sitaxsentan

EXPERIMENTAL

Sitaxsentan

Drug: Sitaxsentan

Interventions

Sitaxsentan DRUG

Sitaxsentan 100 mg tablets once daily

Also known as: Sitaxentan

Sitaxsentan

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Pulmonary Arterial Hypertension (PAH) confirmed by cardiac catheterization.
• Current diagnosis of WHO group 1 PAH with functional class 2, 3, or 4 symptoms.

You may not qualify if:

• Has portal hypertension or chronic liver disease.
• Has history of left sided heart disease or significant cardiac disease.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (91)

Pfizer Investigational Site

Birmingham, Alabama, 35233, United States

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Birmingham, Alabama, 35294, United States

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Phoenix, Arizona, 85013, United States

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Los Angeles, California, 90073, United States

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San Francisco, California, 94143-0124, United States

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Torrence, California, 90502, United States

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Denver, Colorado, 80218, United States

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Denver, Colorado, 80262, United States

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Sarasota, Florida, 34233, United States

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Atlanta, Georgia, 30322, United States

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Augusta, Georgia, 30912, United States

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Decatur, Georgia, 30030, United States

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Decatur, Georgia, 30033, United States

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Chicago, Illinois, 60637, United States

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Kansas City, Kansas, 66160, United States

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Lexington, Kentucky, 40536, United States

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New Orleans, Louisiana, 70112-1393, United States

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New Orleans, Louisiana, 70112, United States

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Portland, Maine, 04102, United States

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Baltimore, Maryland, 21205, United States

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Boston, Massachusetts, 02111, United States

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Boston, Massachusetts, 02114, United States

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Boston, Massachusetts, 02118, United States

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Boston, Massachusetts, 02218, United States

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Ann Arbor, Michigan, 48109-0570, United States

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Detroit, Michigan, 48201, United States

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Rochester, Minnesota, 55905, United States

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New Brunswick, New Jersey, 08903-0019, United States

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New York, New York, 10032, United States

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Durham, North Carolina, 27710, United States

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Cleveland, Ohio, 44106, United States

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Cleveland, Ohio, 44195, United States

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Columbus, Ohio, 43210, United States

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Philadelphia, Pennsylvania, 19140, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Charleston, South Carolina, 29425, United States

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Nashville, Tennessee, 37232-2650, United States

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Nashville, Tennessee, 37232-5735, United States

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Nashville, Tennessee, 37232, United States

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Galveston, Texas, 77555-0561, 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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Salt Lake City, Utah, 84143, United States

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Milwaukee, Wisconsin, 53215, United States

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Milwaukee, Wisconsin, 53226, United States

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Capital Federal, Buenos Aires, C1416ASA, Argentina

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Capital Federal, C1039AAO, Argentina

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Darlinghurst, New South Wales, 2010, Australia

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Chermside Q, Queensland, 4032, Australia

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Melbourne, Victoria, 3004, Australia

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Chermside, QLD 4032, Australia

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Graz, 8036, Austria

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Vienna, 1090, Austria

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Brussels, 1070, Belgium

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Leuven, B - 3000, Belgium

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Belo Horizonte, Minas Gerais, 30380-090, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

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São Paulo, 05403-000, Brazil

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Calgary, Alberta, T1Y 6J4, Canada

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Edmonton, Alberta, T6G 2B7, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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London, Ontario, N6A 4G5, Canada

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Toronto, Ontario, M5G 2C4, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Québec, Quebec, G1V 4G5, Canada

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Clamart, 92141, France

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Grenoble, 38043, France

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Strasbourg, 67098, France

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Berlin, 14050, Germany

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Dresden, 01307, Germany

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Giessen, 35392, Germany

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Greifswald, 17487, Germany

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Hanover, 30625, Germany

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Heidelberg, 69120, Germany

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Leipzig, 04103, Germany

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Regensburg, 93053, Germany

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Petah Tikva, 49100, Israel

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Tel-Hashomer, Ramat Gan, 52601, Israel

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Bologna, 40138, Italy

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Monterrey, CP, 64020, Mexico

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Tlalpan, Mexico City, 14080, Mexico

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Monterrey, N.l., 64360, Mexico

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Amsterdam, 1081 HV, Netherlands

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Krakow, 31-202, Poland

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Warsaw, 01-138, Poland

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Zabrze, 41-800, Poland

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Barcelona, Barcelona, 08036, Spain

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Papworth Everard, Cambridgeshire, CB3 8RB, United Kingdom

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Glasgow, G11 6NT, United Kingdom

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London, NW3 2QG, United Kingdom

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Newcastle, NE7 7DN, United Kingdom

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Related Links

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

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

sitaxsentan

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Mean and dispersion for clinical abnormalities were intended to be reported but due to early termination of study (09-Dec-2010) only number and percent of participants are available.

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: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 18, 2008
• Study Start: March 1, 2003
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: April 24, 2012
• Results First Posted: April 24, 2012

Record last verified: 2011-11

Locations

IL (2); AU (2); IT (1); CA (7); ME (3); FR (3); NL (1); BR (3); DE (8); GB (4); ES (1); BE (2); PL (3); US (45); AR (2)