Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as sitaxsentan (Thelin), Open
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 a small molecule drug candidate that Pfizer, Inc. (ticker: PFE) has studied in the cardiovascular therapeutic area. It is also known as sitaxsentan (Thelin). The specific indication pursued in its clinical program is undisclosed, and the asset has reached Phase 2 testing.
Sitaxsentan is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the clinical work conducted on the compound, including the Phase 2 study run in the United States in patients undergoing heart surgery.
Sitaxsentan is in Phase 2 development. It is an investigational small molecule and is not described as approved. One Phase 2 trial has been completed, and no trials are currently active, so the program's recorded clinical activity consists of that finished study.
Sitaxsentan has been studied in one completed Phase 2 trial, NCT00838383, titled Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery. That randomized, placebo-controlled study enrolled 29 participants in the United States, including subjects undergoing CABG and/or cardiac valve replacement, with a minimum age of 48 years.
Yes. Sitaxsentan is also known as sitaxsentan (Thelin), so searches for Thelin refer to the same compound. It is a small molecule developed by Pfizer, Inc. (ticker: PFE) in the cardiovascular therapeutic area and has been tested at the Phase 2 stage.