Trial · NCT00838383
Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery
NCT00838383, Phase 2, Completed, Pfizer; results first posted 2022-09-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery. Trials, record NCT00838383. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00838383
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery
- NCT number
- NCT00838383
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Cardiac Surgery Subjects, Subjects Undergoing CABG and/or Cardiac Valve Replacement
- Interventions
- sitaxsentan (Thelin), sitaxsentan (Thelin), Placebo
- First posted
- 2009-02-06
- Last updated
- 2022-09-08
- Results first posted
- 2022-09-08
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 0 hour, 0.5 hour post-separation from CPB | PVR in participants was derived from mean pulmonary artery pressure (PAP) (millimeter of mercury \[mmHg\]), pulmonary capillary wedge pressure (PCWP \[mmHg\]) and cardiac output (CO \[litres per minute\]). It was calculated using the following formula: (\[mean PAP-PCWP\] divided by CO)\*80, where CO= stroke volume (SV)\*heart rate (HR). Post-separation from CPB was the time immediately following cross-clamp release in CPB. Percent change in PVR at 0.5 hour post-separation from CPB in participants were summarized and reported. |
| Primary | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 6 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 0 hour, 6 hour post-separation from CPB | PVR in participants was derived from mean PAP (mmHg), PCWP (mmHg) and CO (litres per minute). It was calculated using the following formula: (\[mean PAP-PCWP\] divided by CO)\*80, where CO= SV \* HR. Percent change in PVR at 6 hour in participants were summarized and reported. |
| Primary | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 12 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 0 hour, 12 hour post-separation from CPB | PVR in participants was derived from mean PAP (mmHg), PCWP (mmHg) and CO (litres per minute). It was calculated using the following formula: (\[mean PAP-PCWP\] divided by CO)\*80, where CO= SV \* HR. Percent change in PVR at 12 hour in participants were summarized and reported. |
| Primary | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 24 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 0 hour, 24 hour post-separation from CPB | PVR in participants was derived from mean PAP (mmHg), PCWP (mmHg) and CO (litres per minute). It was calculated using the following formula: (\[mean PAP-PCWP\] divided by CO)\*80, where CO= SV \* HR. Percent change in PVR at 24 hour in participants were summarized and reported. |
| Primary | Mortality: Number of Participants Died During Surgery and Initial Hospitalization | During surgery, initial hospitalization period (up to 29 days for 1 mg/kg group, up to 44 days for 2 mg/kg dose group, up to 19 days for placebo group) | Number of participants who died during surgery or during initial hospitalization are reported here. |
| Primary | Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation | Initial hospitalization period (up to 44 days) | Number of participants with following incidents: myocardial infarction (Q and non-Q wave); stroke or cerebrovascular event (acute ischemia, hemorrhagic stroke or infarction, or a transient ischemia attack); hemodynamic collapse (requiring ventricular assistance devices) and re-operation (participants who returned to the operating room) during the initial hospitalization were reported. |
| Secondary | Number of Participants With Inotropic Requirements During the 24 Hours Postoperative Period | Immediately after cross-clamp removal up to 24 hours post-separation from CPB | Participants were considered for inotropic requirements/therapy in case of either severe right ventricular failure or high pulmonary artery pressure, or if cardiac output was not maintained with epinephrine. |
| Secondary | Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | 0, 0.5, 6, 12, 24 hours post-separation from CPB | CO was calculated by multiplying stroke volume (SV) with heart rate (HR). It was used to evaluate the hemodynamic profile of each participant. |
| Secondary | Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | 0, 0.5, 6, 12, 24 hours post-separation from CPB | |
| Secondary | Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | 0, 0.5, 6, 12, 24 hours post-separation from CPB | The hematocrit is percentage of the volume of whole blood that is made up of red blood cells (RBCs). |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 0 hour, 0.5 hour post-separation from CPB | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | percent change | MEAN |
| PRIMARY | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 6 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 0 hour, 6 hour post-separation from CPB | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | percent change | MEAN |
| PRIMARY | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 12 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 0 hour, 12 hour post-separation from CPB | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | percent change | MEAN |
| PRIMARY | Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 24 Hour Post-separation From Cardiopulmonary Bypass (CPB) | 0 hour, 24 hour post-separation from CPB | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | percent change | MEAN |
| PRIMARY | Mortality: Number of Participants Died During Surgery and Initial Hospitalization | During surgery, initial hospitalization period (up to 29 days for 1 mg/kg group, up to 44 days for 2 mg/kg dose group, up to 19 days for placebo group) | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. | participants | NUMBER |
| PRIMARY | Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation | Initial hospitalization period (up to 44 days) | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. | participants | NUMBER |
| SECONDARY | Number of Participants With Inotropic Requirements During the 24 Hours Postoperative Period | Immediately after cross-clamp removal up to 24 hours post-separation from CPB | Data was not collected, since this outcome was not analyzed as per Sponsor's discretion. | ||
| SECONDARY | Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | 0, 0.5, 6, 12, 24 hours post-separation from CPB | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the last observation carried forward (LOCF) method. | liters per minute | MEAN |
| SECONDARY | Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB) | 0, 0.5, 6, 12, 24 hours post-separation from CPB | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB) | 0, 0.5, 6, 12, 24 hours post-separation from CPB | Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. | percentage of red blood cells in blood | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group207
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB) | Sitaxsentan (1 mg/kg) | -7.75 | Standard Deviation 55.277 | percent change | |
| Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB) | Sitaxsentan (2 mg/kg) | -10.94 | Standard Deviation 37.967 | percent change | |
| Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB) | Placebo | 62.22 | Standard Deviation 260.172 | percent change | |
| Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 6 Hour Post-separation From Cardiopulmonary Bypass (CPB) | Sitaxsentan (1 mg/kg) | 39.36 | Standard Deviation 61.615 | percent change | |
| Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 6 Hour Post-separation From Cardiopulmonary Bypass (CPB) | Sitaxsentan (2 mg/kg) | -12.01 | Standard Deviation 39.561 | percent change | |
| Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 6 Hour Post-separation From Cardiopulmonary Bypass (CPB) | Placebo | 173.68 | Standard Deviation 511.269 | percent change | |
| Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 12 Hour Post-separation From Cardiopulmonary Bypass (CPB) | Sitaxsentan (1 mg/kg) | 31.42 | Standard Deviation 67.887 | percent change | |
| Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 12 Hour Post-separation From Cardiopulmonary Bypass (CPB) | Sitaxsentan (2 mg/kg) | -12.32 | Standard Deviation 37.517 | percent change | |
| Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 12 Hour Post-separation From Cardiopulmonary Bypass (CPB) | Placebo | 98.03 | Standard Deviation 283.333 | percent change | |
| Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 24 Hour Post-separation From Cardiopulmonary Bypass (CPB) | Sitaxsentan (1 mg/kg) | 18.06 | Standard Deviation 63.362 | percent change |
1 to 10 of 207Source ClinicalTrials.gov
See all 207 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sitaxsentan (1 mg/kg) | 9 | |
| Overall Study | STARTED | Sitaxsentan (2 mg/kg) | 10 | |
| Overall Study | STARTED | Placebo | 10 | |
| Overall Study | COMPLETED | Sitaxsentan (1 mg/kg) | 9 | |
| Overall Study | COMPLETED | Sitaxsentan (2 mg/kg) | 10 | |
| Overall Study | COMPLETED | Placebo | 10 | |
| Overall Study | NOT COMPLETED | Sitaxsentan (1 mg/kg) | 0 | |
| Overall Study | NOT COMPLETED | Sitaxsentan (2 mg/kg) | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events303
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 (1 mg/kg) | 1 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Sitaxsentan (2 mg/kg) | 1 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 10 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Sitaxsentan (1 mg/kg) | 0 | 9 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Sitaxsentan (2 mg/kg) | 1 | 10 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Placebo | 0 | 10 | |
| other | Arrhythmia supraventricular | Cardiac disorders | Sitaxsentan (1 mg/kg) | 0 | 9 | |
| other | Arrhythmia supraventricular | Cardiac disorders | Sitaxsentan (2 mg/kg) | 1 | 10 | |
| other | Arrhythmia supraventricular | Cardiac disorders | Placebo | 1 | 10 | |
| other | Atrial fibrillation | Cardiac disorders | Sitaxsentan (1 mg/kg) | 4 | 9 |
1 to 10 of 303Source ClinicalTrials.gov
See all 303 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sitaxsentan (1 mg/kg) | ||
| Total, all-cause mortality | Sitaxsentan (2 mg/kg) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Sitaxsentan (1 mg/kg) | 9 | 9 |
| Total, other adverse events | Sitaxsentan (2 mg/kg) | 9 | 10 |
| Total, other adverse events | Placebo | 9 | 10 |
| Total, serious adverse events | Sitaxsentan (1 mg/kg) | 2 | 9 |
| Total, serious adverse events | Sitaxsentan (2 mg/kg) | 5 | 10 |
| Total, serious adverse events | Placebo | 4 | 10 |
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.
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GET https://conductscience.org/api/trials/v1/NCT00838383/registered?page=2