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Published on: July 25, 2020
Tezosentan. Actelion/Genentech
Enrico Rossetti1, Stefano De Servi
1UO Cardiologia, Ospedale Civile di Legnano 20025 Legano, Milan, Italy.
Insights
Tezosentan, an endothelin receptor antagonist, showed disappointing results in a Phase III acute heart failure trial. A new study using lower doses was planned, with results anticipated by early 2005.
Area of Science:
- Cardiovascular medicine
- Pharmacology
Background:
- Tezosentan is an endothelin receptor antagonist developed for cardiovascular disorders.
- Acute heart failure (AHF) and congestive heart failure are target conditions.
Purpose of the Study:
- To evaluate the efficacy and safety of tezosentan in AHF patients.
- To assess mortality and morbidity in a Phase III trial.
Main Methods:
- A Phase III clinical study was conducted in AHF patients.
- Lower doses of tezosentan were planned for a subsequent Phase III study following initial disappointing results.
Main Results:
- Initial Phase III trial results for tezosentan in AHF were disappointing.
- A new Phase III study was planned with adjusted dosing.
Conclusions:
- Further investigation with modified dosing was deemed necessary for tezosentan in AHF.
- Clinical trial outcomes guide the development of cardiovascular therapies.
Abstract:
Tezosentan is an endothelin receptor antagonist in development by Actelion Ltd and Genentech Inc for the potential treatment of cardiovascular disorders, including acute heart failure (AHF) and congestive heart failure. Actelion has conducted a phase III study of tezosentan in AHF patients, however, following disappointing trial results a new phase III study in AHF was planned using lower doses of the compound. By January 2003, Actelion anticipated that the first results of a two-year phase III study evaluating mortality/morbidity would be available by early 2005.
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