Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
sitaxsentan · 1 trial · 2 indications
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.
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.
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.
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.
Number of participants who died during surgery or during initial hospitalization are reported here.
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.
| Arm | Type | Description |
|---|---|---|
| sitaxsentan (1.0 mg/kg) | EXPERIMENTAL | - |
| sitaxsentan (2.0 mg/kg) | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| sitaxsentan (Thelin) | DRUG | sitaxsentan (1.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB. |
| Placebo | DRUG | Placebo will begin immediately following cross-clamp release and 12 hours post-CPB. |
Inclusion Criteria: * Has been identified for coronary artery bypass grafting (CABG), aortic and/or mitral valve replacement, or combined CABG and cardiac valve replacement procedures that require cardiopulmonary bypass (CPB). Exclusion Criteria: * Requires an emergent or "emergency" CABG and/or ...
Sitaxsentan is an investigational small molecule being studied for use in cardiac surgery subjects, specifically patients undergoing coronary artery bypass grafting (CABG) and/or cardiac valve replacement. It is in Phase 2 clinical development for this cardiovascular indication.
Sitaxsentan is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients undergoing heart surgery.
Sitaxsentan is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to determine its safety and effectiveness.
Sitaxsentan has one completed Phase 2 clinical trial, NCT00838383, titled "Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery." This trial enrolled 29 participants in the United States and was placebo-controlled, though not double-blind.
Sitaxsentan is a small molecule that works by targeting and blocking the endothelin receptor, specifically endothelin receptor type A. This action helps to prevent the vasoconstrictive effects of endothelin, which may be beneficial in the context of cardiac surgery.