Trial · NCT00811018
A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension
NCT00811018, Phase 3, Terminated, Pfizer; results first posted 2012-04-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension. Trials, record NCT00811018. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00811018
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension
- NCT number
- NCT00811018
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,192 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Sitaxsentan
- First posted
- 2008-12-18
- Last updated
- 2012-04-24
- Results first posted
- 2012-04-24
- 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.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to 82 months | Safety Population: all enrolled participants who took at least one dose of sitaxsentan 100 mg during the study | participants | NUMBER |
| 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 | Safety Population | percentage of participants | NUMBER |
| 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 | Safety Population | percentage of participants | NUMBER |
| 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 | Safety Population | percentage of participants | NUMBER |
| 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 | Safety Population; N=number of participants with normal observation at baseline; n=number of participants with normal baseline and an abnormality meeting specific criteria for the specific lab | percentage of participants | NUMBER |
| 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 | Safety Population; N=number of participants with normal observation at baseline; n=number of participants with normal baseline and an abnormality meeting specific criteria for the specific lab | percentage of participants | NUMBER |
| 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 | Safety Population; N=number of participants with normal observation at baseline; n=number of participants with normal baseline and an abnormality meeting specific criteria for the specific lab | percentage of participants | NUMBER |
| 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 | Safety Population | percentage of participants | NUMBER |
| 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 | Safety Population | percentage of participants | NUMBER |
| 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 | Data not summarized, study terminated early | percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Sitaxsentan | AEs | 1150 | participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Sitaxsentan | SAEs | 586 | participants | |
| 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) | Sitaxsentan | > 3 x ULN and less than or equal to (<=) 5x ULN | 5.12 | percentage of participants | |
| 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) | Sitaxsentan | > 5 x ULN and <= 8 x ULN | 4.45 | percentage of participants | |
| 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) | Sitaxsentan | > 8 x ULN and <= 10 x ULN | 0.76 | percentage of participants | |
| 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) | Sitaxsentan | > 10 x ULN | 2.60 | percentage of participants | |
| The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN | Sitaxsentan | > 3 x ULN and <= 5 x ULN | 3.94 | percentage of participants | |
| The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN | Sitaxsentan | > 5 x ULN and <= 8 x ULN | 2.60 | percentage of participants | |
| The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN | Sitaxsentan | > 8 x ULN and <= 10 x ULN | 0.67 | percentage of participants | |
| The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN | Sitaxsentan | > 10 x ULN | 1.26 | percentage of participants |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sitaxsentan | 1,192 | |
| Overall Study | COMPLETED | Sitaxsentan | 224 | |
| Overall Study | NOT COMPLETED | Sitaxsentan | 968 |
Source ClinicalTrials.gov
Adverse events455
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Sitaxsentan | 77 | 1,192 | |
| other | Palpitations | Cardiac disorders | Sitaxsentan | 137 | 1,192 | |
| other | Abdominal pain | Gastrointestinal disorders | Sitaxsentan | 93 | 1,192 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Sitaxsentan | 80 | 1,192 | |
| other | Constipation | Gastrointestinal disorders | Sitaxsentan | 82 | 1,192 | |
| other | Diarrhoea | Gastrointestinal disorders | Sitaxsentan | 211 | 1,192 | |
| other | Nausea | Gastrointestinal disorders | Sitaxsentan | 228 | 1,192 | |
| other | Vomiting | Gastrointestinal disorders | Sitaxsentan | 104 | 1,192 | |
| other | Chest pain | General disorders | Sitaxsentan | 201 | 1,192 | |
| other | Fatigue | General disorders | Sitaxsentan | 224 | 1,192 |
1 to 10 of 455Source ClinicalTrials.gov
See all 455 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sitaxsentan | ||
| Total, other adverse events | Sitaxsentan | 1,069 | 1,192 |
| Total, serious adverse events | Sitaxsentan | 586 | 1,192 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00811018
GET https://conductscience.org/api/trials/v1/NCT00811018/results?page=2