A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension (STRIDE-3)

March 29, 2012 updated by: Pfizer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Open-label extension

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1192

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Capital Federal, Argentina, C1039AAO
        • Pfizer Investigational Site
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1416ASA
        • Pfizer Investigational Site
  • Australia
      • Chermside, Australia, QLD 4032
        • Pfizer Investigational Site
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Pfizer Investigational Site
    • Queensland
      • Chermside Q, Queensland, Australia, 4032
        • Pfizer Investigational Site
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Pfizer Investigational Site
  • Austria
      • Graz, Austria, 8036
        • Pfizer Investigational Site
      • Wien, Austria, 1090
        • Pfizer Investigational Site
  • Belgium
      • Bruxelles, Belgium, 1070
        • Pfizer Investigational Site
      • Leuven, Belgium, B - 3000
        • Pfizer Investigational Site
  • Brazil
      • Sao Paulo, Brazil, 05403-000
        • Pfizer Investigational Site
    • MG
      • Belo Horizonte, MG, Brazil, 30380-090
        • Pfizer Investigational Site
    • RS
      • Porto Alegre, RS, Brazil, 90035-003
        • Pfizer Investigational Site
  • Canada
      • Quebec, Canada, G1V 4G5
        • Pfizer Investigational Site
    • Alberta
      • Calgary, Alberta, Canada, T1Y 6J4
        • Pfizer Investigational Site
      • Edmonton, Alberta, Canada, T6G 2B7
        • Pfizer Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Pfizer Investigational Site
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5G 2C4
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Pfizer Investigational Site
  • France
      • Clamart Cedex, France, 92141
        • Pfizer Investigational Site
      • GRENOBLE Cedex 09, France, 38043
        • Pfizer Investigational Site
      • Strasbourg, France, 67098
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 14050
        • Pfizer Investigational Site
      • Dresden, Germany, 01307
        • Pfizer Investigational Site
      • Giessen, Germany, 35392
        • Pfizer Investigational Site
      • Greifswald, Germany, 17487
        • Pfizer Investigational Site
      • Hannover, Germany, 30625
        • Pfizer Investigational Site
      • Heidelberg, Germany, 69120
        • Pfizer Investigational Site
      • Leipzig, Germany, 04103
        • Pfizer Investigational Site
      • Regensburg, Germany, 93053
        • Pfizer Investigational Site
  • Israel
      • Petach Tikva, Israel, 49100
        • Pfizer Investigational Site
      • Tel-Hashomer, Ramat Gan, Israel, 52601
        • Pfizer Investigational Site
  • Italy
      • Bologna, Italy, 40138
        • Pfizer Investigational Site
  • Mexico
    • CP
      • Monterrey, CP, Mexico, 64020
        • Pfizer Investigational Site
    • DF
      • Tlalpan, DF, Mexico, 14080
        • Pfizer Investigational Site
    • N.l.
      • Monterrey, N.l., Mexico, 64360
        • Pfizer Investigational Site
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Pfizer Investigational Site
  • Poland
      • Krakow, Poland, 31-202
        • Pfizer Investigational Site
      • Warszawa, Poland, 01-138
        • Pfizer Investigational Site
      • Zabrze, Poland, 41-800
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Pfizer Investigational Site
  • United Kingdom
      • Glasgow, United Kingdom, G11 6NT
        • Pfizer Investigational Site
      • London, United Kingdom, NW3 2QG
        • Pfizer Investigational Site
      • Newcastle, United Kingdom, NE7 7DN
        • Pfizer Investigational Site
    • Cambridgeshire
      • Papworth Everard, Cambridgeshire, United Kingdom, CB3 8RB
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35294
        • Pfizer Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Pfizer Investigational Site
    • California
      • Los Angeles, California, United States, 90073
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94143-0124
        • Pfizer Investigational Site
      • Torrence, California, United States, 90502
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80262
        • Pfizer Investigational Site
      • Denver, Colorado, United States, 80218
        • Pfizer Investigational Site
    • Florida
      • Sarasota, Florida, United States, 34233
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Pfizer Investigational Site
      • Augusta, Georgia, United States, 30912
        • Pfizer Investigational Site
      • Decatur, Georgia, United States, 30033
        • Pfizer Investigational Site
      • Decatur, Georgia, United States, 30030
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Pfizer Investigational Site
      • New Orleans, Louisiana, United States, 70112-1393
        • Pfizer Investigational Site
    • Maine
      • Portland, Maine, United States, 04102
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02114
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02111
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02218
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0570
        • Pfizer Investigational Site
      • Detroit, Michigan, United States, 48201
        • Pfizer Investigational Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Pfizer Investigational Site
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903-0019
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10032
        • Pfizer Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States, 44195
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43210
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37232-5735
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37232-2650
        • Pfizer Investigational Site
    • Texas
      • Galveston, Texas, United States, 77555-0561
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84143
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Pfizer Investigational Site
      • Milwaukee, Wisconsin, United States, 53215
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sitaxsentan
Drug: Sitaxsentan
Sitaxsentan 100 mg tablets once daily
Other Names:
  • Sitaxentan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Day 1 up to 82 months
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)
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: 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
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
Time Frame: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
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)
Time Frame: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
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
Time Frame: Weeks 28,60,72,84,96,104, Transition Visit up to 82 months
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
Time Frame: Day 1, Weeks 28,60,72,84,96,104, Transition visit, every 6 months Post Transition, up to 82 months
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)
Time Frame: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
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)
Time Frame: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B1321007
  • FPH03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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