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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00124748 |
This study will investigate safety and efficacy of 400mg and 800mg imatinib in comparison, using molecular endpoints.
Condition | Intervention | Phase |
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Leukemia, Myeloid, Chronic Phase |
Drug: Imatinib mesylate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy of 400 Mg Versus 800 Mg Imatinib in Chronic Myeloid Leukemia in Chronic Phase Patients |
Estimated Enrollment: | 420 |
Study Start Date: | June 2005 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Novartis | Novartis |
Study ID Numbers: | CSTI571K2301 |
Study First Received: | July 27, 2005 |
Last Updated: | December 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00124748 |
Health Authority: | United States: Food and Drug Administration |
CML Philadelphia positive Bcr-abl imatinib mesylate Chronic myeloid leukemia (CML) in chronic phase |
Imatinib Leukemia Chronic myelogenous leukemia Hematologic Diseases Myeloproliferative Disorders |
Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid Bone Marrow Diseases |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |