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Tezosentan. Actelion/Genentech.

Enrico Rossetti1, Stefano De Servi

  • 1UO Cardiologia, Ospedale Civile di Legnano 20025 Legano, Milan, Italy.

Current Opinion in Investigational Drugs (London, England : 2000)
|May 9, 2003
PubMed
Summary
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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.

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Conclusions:

  • Further investigation with modified dosing was deemed necessary for tezosentan in AHF.
  • Clinical trial outcomes guide the development of cardiovascular therapies.