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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
Sponsor:
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by:
Icagen

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 ]
Not Provided
Not Provided
Not Provided
 
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
Interventional
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.
 
Terminated
297
300
June 2007
Not Provided

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)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   France,   Jamaica,   Trinidad and Tobago,   United Kingdom,   United States
 
 
NCT00102791
ICA-17043-10
Yes
Not Provided
Not Provided
Not Provided
Icagen
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Study Director: Jonathan W Stocker, Ph.D. Icagen
Icagen
September 2007

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