Trials / Terminated
TerminatedNCT00102791
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 297 (actual)
- Sponsor
- Icagen · Industry
- Sex
- All
- Age
- 16 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ICA-17043 |
Timeline
- Start date
- 2005-02-01
- Completion
- 2007-06-01
- First posted
- 2005-02-02
- Last updated
- 2008-03-27
Locations
49 sites across 6 countries: United States, Brazil, France, Jamaica, Trinidad and Tobago, United Kingdom
Source: ClinicalTrials.gov record NCT00102791. Inclusion in this directory is not an endorsement.