MedTrace Logo

A Stratified Sickle Event Randomized Trial (ASSERT)

NCT00102791 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 297

Last updated 2008-03-27

No results posted yet for this study

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

DRUG

ICA-17043

Sponsors & Collaborators

  • McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

    collaborator INDUSTRY

  • Icagen

    lead INDUSTRY

Principal Investigators

  • Jonathan W Stocker, Ph.D. · Icagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Completion
2007-06-30

Countries

  • United States
  • Brazil
  • France
  • Jamaica
  • Trinidad and Tobago
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00102791 on ClinicalTrials.gov