A Stratified Sickle Event Randomized Trial (ASSERT)

Phase 3 Terminated 297 enrolled Icagen McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to compare the effects of ICA-17043 to placebo with or without hydroxyurea (an oral drug used for treatment of sickle cell disease) in patients with sickle cell disease who have had 2 or more acute sickle-related painful crises requiring a visit to a medical facility within the past 12 months.

Timeline

Start: 2005-02
Primary completion: —
Completion: 2007-06

Publications

Background Stocker JW, De Franceschi L, McNaughton-Smith GA, Corrocher R, Beuzard Y, Brugnara C. ICA-17043, a novel Gardos channel blocker, prevents sickled red blood cell dehydration in vitro and in vivo in SAD mice. Blood. 2003 Mar 15;101(6):2412-8. doi: 10.1182/blood-2002-05-1433. Epub 2002 Nov 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Senicapoc	Small molecule	—	—

A Stratified Sickle Event Randomized Trial (ASSERT)

Summary

Timeline

Publications

Drugs

Indications