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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00000586 |
To assess the efficacy and safety of orally administered hydroxyurea in the treatment of painful crises in patients with sickle cell anemia.
Condition | Intervention | Phase |
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Anemia, Sickle Cell Hematologic Diseases Hemoglobinopathies |
Drug: hydroxyurea |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | Multicenter Study of Hydroxyurea in Patients With Sickle Cell Anemia (MSH) |
Study Start Date: | January 1992 |
Study Completion Date: | June 1994 |
Primary Completion Date: | June 1994 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Men and women, ages 18 to 50, who had at least three emergency room visits or hospitalizations for sickle cell anemia during the year prior to recruitment. Patients with greater than 20 crises per year were included. A total of 295 patients had Hb ss and four had Hb SB thalassemia.
Study ID Numbers: | 306 |
Study First Received: | October 27, 1999 |
Last Updated: | January 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00000586 |
Health Authority: | United States: Federal Government |
Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Hydroxyurea Hematologic Diseases Hemoglobinopathies |
Anemia Anemia, Hemolytic Hemoglobinopathy Anemia, Sickle Cell Sickle cell anemia |
Antisickling Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Hematologic Agents Enzyme Inhibitors Nucleic Acid Synthesis Inhibitors Pharmacologic Actions |