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Also known as Sitexsentin sodium
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 developed by Pfizer, Inc. for diastolic heart failure, a cardiovascular condition. It has been studied in a Phase 2 clinical trial. Sitexsentin is also known as Sitexsentin sodium.
Sitexsentin is being studied for the treatment of diastolic heart failure. A Phase 2 trial evaluated its effectiveness in patients with this condition. It is an investigational therapy and has not been approved for commercial use.
Sitexsentin is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. Pfizer sponsored the clinical research program for this small molecule in cardiovascular disease.
Sitexsentin is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are currently listed. It remains an investigational drug and is not approved for marketing.
Sitexsentin has been studied in one completed Phase 2 trial, NCT00303498, titled a study of the effectiveness of Sitaxsentan Sodium in patients with diastolic heart failure. The trial enrolled 200 patients across the United States and Canada and was randomized, double-blind, and placebo-controlled.
Yes, Sitexsentin sodium is another name for Sitexsentin. The Phase 2 trial in diastolic heart failure was conducted under the name Sitaxsentan Sodium, so searches for either name refer to the same investigational compound developed by Pfizer.