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Sitexsentin · 1 trial · 1 indication
Treadmill exercise test is used to assess the functional capacity of participants with cardiac disease. Treadmill exercise test was conducted using the 2 minute incremental Naughton protocol. The Naughton protocol starts with a 2 minute warm-up. The speed of treadmill is set to 1 mile per hour (mph) and the incline is set to 0. After the warm-up, the speed is set at 2 mph for the remainder of the test. The test consists of six, 2 minute intervals. The grade starts at 0 for the first interval, and increases by 3.5 percent every 2 minutes. The change in total exercise time (in seconds) during the treadmill test was reported.
| Arm | Type | Description |
|---|---|---|
| Sitaxsentan sodium | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Sitexsentin sodium | DRUG | sitaxsentan 100 mg (target dose) 0rally once daily. A 10-week Run-In Phase was conducted where dosing commenced at 25 mg daily for 2 weeks, and then was stepped up to 50 mg daily for 2 weeks, to 75 mg daily for 2 weeks and then to 100 mg daily for 2 weeks, with an additional 2-week stabilization period (10 weeks total) to a target study dose of 100 mg daily. During the Run-In Phase, if a subject was not able to tolerate upward dose titration to the target dose of 100 mg, the investigator may have elected to continue at the current dosage or reduce the dosage of sitaxsentan or placebo to the subject's immediate prior dose. During the Maintenance Phase, subjects received the highest titrated dose reached of study drug and continued it through the last day of Week M24 of the Maintenance Phase (14 weeks)- total study drug treatment duration= 6 months |
| Placebo | DRUG | placebo identical to the study drug in description, dose and duration |
Inclusion Criteria: * 18 or older with chronic heart failure and evidence of diastolic dysfunction on echocardiogram, heart imaging, and a minimum exercise tolerance average time of 120 seconds on two treadmill tests within 2 weeks of enrollment Exclusion Criteria: * unstable cardiovascular disea...
Sitexsentin is an investigational small molecule being studied for the treatment of diastolic heart failure, a condition in which the heart's lower chambers have trouble relaxing and filling with blood. It is being developed by Pfizer, Inc. and is currently in Phase 2 clinical development.
Sitexsentin is a small molecule designed to address diastolic heart failure. Its specific molecular target has not been disclosed in available information, so the exact mechanism of action is not detailed here.
Sitexsentin is being developed by Pfizer, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 2 clinical trials for diastolic heart failure.
Sitexsentin is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 trial has been completed to evaluate its effectiveness in patients with diastolic heart failure.
Sitexsentin has been studied in one completed Phase 2 trial, identified as NCT00303498. This randomized, double-blind, placebo-controlled study enrolled 200 participants with diastolic heart failure and was conducted in the United States and Canada.
Sitexsentin is a variant name for the drug also known as Sitaxsentan. The clinical trial NCT00303498 refers to the drug as Sitaxsentan Sodium, indicating that Sitexsentin and Sitaxsentan refer to the same investigational compound.