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Sponsors and Collaborators: |
University of Colorado at Denver and Health Sciences Center Merck National Institutes of Health (NIH) |
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Information provided by: | University of Colorado at Denver and Health Sciences Center |
ClinicalTrials.gov Identifier: | NCT00477204 |
The purpose of the study is to establish the safety of Zocor and Vytorin in adolescents with Type 1 Diabetes and to determine the amount of decrease in LDL-cholesterol.The study hypothesizes that Zocor and Vytorin will be safe in adolescents with Type 1 Diabetes and will lower LDL-cholesterol at 6 months.
Condition | Intervention | Phase |
---|---|---|
Type 1 Diabetes Mellitus Dyslipidemia |
Drug: Zocor (simvastatin), Vytorin (ezetimibe/simvastatin) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Clinical Trial of Zocor and Vytorin in Adolescents With Type 1 Diabetes |
Estimated Enrollment: | 82 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | October 2008 |
Cardiovascular disease is the leading cause of death in people with type 1 diabetes mellitus (T1DM) and since atherosclerosis begins in childhood, data to inform clinicians as to appropriate dyslipidemia treatment in this high-risk population are of great public health importance. In this trial of lipid-lowering medications (Zocor [simvastatin], a statin, compared to Vytorin [ezetimibe/simvastatin], a combination of a statin and Zetia, a medication that blocks cholesterol absorption) will be performed in patients ages 12-18 years with LDL ≥ 130 mg/dl, consistent with current ADA guidelines. The study hypothesizes that Zocor and Vytorin will be safe in adolescents with T1DM and will lower LDL-cholesterol at 6 months compared to baseline. In a two-arm design, Vytorin will lower LDL-c more than monotherapy with Zocor.
Ages Eligible for Study: | 12 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Franziska K Bishop, MS | 3037246764 | franziska.bishop@uchsc.edu |
Contact: David M Maahs, MD | 3037246706 | david.maahs@uchsc.edu |
United States, Colorado | |
Barbara Davis Center for Childhood Diabetes | Recruiting |
Aurora, Colorado, United States, 80045 |
Principal Investigator: | David M Maahs, MD | University of Colorado at Denver and Health Sciences Center |
Principal Investigator: | R. Paul Wadwa, MD | University of Colorado at Denver and Health Sciences Center |
Study ID Numbers: | 06-1036, 843 |
Study First Received: | May 21, 2007 |
Last Updated: | May 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00477204 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Type 1 Diabetes Mellitus dyslipidemia adolescents |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Simvastatin Diabetes Mellitus Endocrine System Diseases |
Ezetimibe Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Molecular Mechanisms of Pharmacological Action Immune System Diseases Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |