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

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT00811018

Acronym / sponsor ID

STRIDE-3 / B1321007

Conditions

Pulmonary Arterial Hypertension

Keywords

Open-label study

Phase

Phase 3

Study type

Interventional

Recruitment status

TerminatedReason stopped: This trial was prematurely terminated on Dec 9 2010 due to safety concerns, specifically emerging evidence of hepatic injury.

Enrolment

1,192 participants (actual)

Lead sponsor

PfizerIndustry (pharma, biotech, devices)

Study start

Mar 2003

Primary completion

Jul 2011 (actual)

Study completion

Jul 2011 (actual)

First posted

18 Dec 2008 (estimated)

Results

Posted 24 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation

Non-randomised

Intervention model

Single group

Masking

None (open label)

Number of arms

1

Who may qualify

Ages

12 to 75 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Child, Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2012.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

91 sites in 16 countries: see every site and its status.