Status:
TERMINATED
A Stratified Sickle Event Randomized Trial (ASSERT)
Lead Sponsor:
Icagen
Collaborating Sponsors:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
16-65 years
Phase:
PHASE3
Brief 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 wh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
297 Patients enrolled
Trial Details
Trial ID
NCT00102791
Start Date
February 1 2005
End Date
June 1 2007
Last Update
March 27 2008
Active Locations (49)
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1
Mobile, Alabama, United States
2
Little Rock, Arkansas, United States
3
Davis, California, United States
4
Los Angeles, California, United States