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NCT00811018 Clinical Trial

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

Pulmonary Arterial Hypertension Clinical Trial

— STRIDE-3  

Official title:
A Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00811018
Other study ID # B1321007
Secondary ID FPH03
Status Terminated
Phase Phase 3
First received December 9, 2008
Last updated March 29, 2012
Start date March 2003
Est. completion date July 2011

Study information
Verified date November 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Description:

Open-label extension

Recruitment information / eligibility
Status Terminated
Enrollment 1192
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 75 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Has portal hypertension or chronic liver disease.

- Has history of left sided heart disease or significant cardiac disease.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• Sitaxsentan
Sitaxsentan 100 mg tablets once daily

Locations
Country Name City State
Argentina Pfizer Investigational Site Capital Federal Buenos Aires
Argentina Pfizer Investigational Site Capital Federal
Australia Pfizer Investigational Site Chermside
Australia Pfizer Investigational Site Chermside Q Queensland
Australia Pfizer Investigational Site Darlinghurst New South Wales
Australia Pfizer Investigational Site Melbourne Victoria
Austria Pfizer Investigational Site Graz
Austria Pfizer Investigational Site Wien
Belgium Pfizer Investigational Site Bruxelles
Belgium Pfizer Investigational Site Leuven
Brazil Pfizer Investigational Site Belo Horizonte MG
Brazil Pfizer Investigational Site Porto Alegre RS
Brazil Pfizer Investigational Site Sao Paulo
Canada Pfizer Investigational Site Calgary Alberta
Canada Pfizer Investigational Site Edmonton Alberta
Canada Pfizer Investigational Site London Ontario
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Quebec
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Vancouver British Columbia
France Pfizer Investigational Site Clamart Cedex
France Pfizer Investigational Site GRENOBLE Cedex 09
France Pfizer Investigational Site Strasbourg
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Dresden
Germany Pfizer Investigational Site Giessen
Germany Pfizer Investigational Site Greifswald
Germany Pfizer Investigational Site Hannover
Germany Pfizer Investigational Site Heidelberg
Germany Pfizer Investigational Site Leipzig
Germany Pfizer Investigational Site Regensburg
Israel Pfizer Investigational Site Petach Tikva
Israel Pfizer Investigational Site Tel-Hashomer, Ramat Gan
Italy Pfizer Investigational Site Bologna
Mexico Pfizer Investigational Site Monterrey CP
Mexico Pfizer Investigational Site Monterrey N.l.
Mexico Pfizer Investigational Site Tlalpan DF
Netherlands Pfizer Investigational Site Amsterdam
Poland Pfizer Investigational Site Krakow
Poland Pfizer Investigational Site Warszawa
Poland Pfizer Investigational Site Zabrze
Spain Pfizer Investigational Site Barcelona
United Kingdom Pfizer Investigational Site Glasgow
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site Newcastle
United Kingdom Pfizer Investigational Site Papworth Everard Cambridgeshire
United States Pfizer Investigational Site Ann Arbor Michigan
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Augusta Georgia
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Charleston South Carolina
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Decatur Georgia
United States Pfizer Investigational Site Decatur Georgia
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Detroit Michigan
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Galveston Texas
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Kansas City Kansas
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Milwaukee Wisconsin
United States Pfizer Investigational Site Milwaukee Wisconsin
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New Brunswick New Jersey
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site Portland Maine
United States Pfizer Investigational Site Rochester Minnesota
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Francisco California
United States Pfizer Investigational Site Sarasota Florida
United States Pfizer Investigational Site Torrence California

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  France,  Germany,  Israel,  Italy,  Mexico,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
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