Trial · NCT00811018
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. |
| 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) | 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. |
| Primary | The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN | 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. |
| Primary | Percentage of Participants With Total Bilirubin > 1.5 x ULN | 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. |
| Primary | Percentage of Participants With Laboratory Test Abnormalities (Hematology) | 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. |
| Primary | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | 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. |
| Primary | Percentage of Participants With Laboratory Test Abnormalities (Urinalysis) | 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. |
| Primary | Percentage of Participants With Anticoagulant Use | 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. |
| Primary | Percentage of Participants With Elevated International Normalize Ratio (INR) | 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. |
| Primary | Percentage of Participants With Electrocardiography (ECG) Results of Potential Clinical Importance | 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. |
| Primary | Percentage of Participants With Vital Sign Results of Potential Clinical Importance | 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. |
| Primary | Percentage of Participants With Abnormal Prothrombin Time (PT) | 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. |
| Primary | Percentage of Participants With Abnormal Partial Thromboplastin Time (PTT) | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT00811018/registered