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A Stratified Sickle Event Randomized Trial (ASSERT) (ASSERT)

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ClinicalTrials.gov Identifier: NCT00102791
Recruitment Status : Terminated (Because of the low probability of achieving the primary endpoint.)
First Posted : February 2, 2005
Last Update Posted : March 27, 2008
Information provided by:

February 1, 2005
February 2, 2005
March 27, 2008
February 2005
Not Provided
Sickle Cell Crisis Rate [ Time Frame: 52 weeks ]
Sickle Cell Crisis Rate
Complete list of historical versions of study NCT00102791 on ClinicalTrials.gov Archive Site
  • Time to First, Second, and Third Crisis [ Time Frame: 52 Weeks ]
  • Maximum Crisis Morbidity Ranking [ Time Frame: 52 Weeks ]
  • Efficacy Related Laboratory Parameters [ Time Frame: 52 Weeks ]
  • Quality of Life [ Time Frame: 52 Weeks ]
  • Health Economics [ Time Frame: 52 Weeks ]
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A Stratified Sickle Event Randomized Trial (ASSERT)
A Phase III Multicenter, 52-Week, Randomized, Double-Blind, Placebo-Controlled Study of the Clinical Efficacy and Safety of ICA-17043 With or Without HU Therapy in Patients With Sickle Cell Disease Who Have Had =>2 Acute Sickle-Related Painful Crises Within the Preceding 12 Months
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Sickle Cell Disease
Drug: ICA-17043
Not Provided
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. Epub 2002 Nov 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2007
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Inclusion Criteria:

  • 16 to 65 years of age (inclusive)
  • Male or female (not capable of becoming pregnant or using appropriate birth control)
  • Medical history of sickle cell disease
  • Have a history of at least two or more acute sickle-related painful crises requiring a visit to a medical facility within the preceding 12 months

Exclusion Criteria:

  • Hemoglobin <4 or >11 g/dL
  • On a chronic transfusion program
  • Has significant active and poorly controlled (unstable) cardiovascular, neurologic, endocrine, hepatic, or renal disorders clearly unrelated to sickle cell disease
Sexes Eligible for Study: All
16 Years to 65 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
Brazil,   France,   Jamaica,   Trinidad and Tobago,   United Kingdom,   United States
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McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Study Director: Jonathan W Stocker, Ph.D. Icagen
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP