At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 9 enrolled
Drug / intervention
Simvastatin +1 moredrug
Likely dose
Simvastatin 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Trial of Zocor and Vytorin in Adolescents With Type 1 Diabetes
In Brief
A Phase 2 clinical trial evaluating Simvastatin and Ezetimibe/Simvastatin for Type 1 Diabetes Mellitus and Dyslipidemia. Completed, enrolled 9 participants across 1 site.
Detailed Summary
The purpose of the study is to establish the safety of ezetimibe/simvastatin and simvastatin in adolescents with Type 1 Diabetes and to determine the amount of decrease in LDL-cholesterol.The study hypothesizes that simvastatin and ezetimibe/simvastatin will be safe in adolescents with Type 1 Diabetes and will lower LDL-cholesterol at 6 months.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus, Dyslipidemia
CountriesUnited States
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2007
First PostedMay 2007
Primary CompletionAug 2010
TodayJul 2026
First PostedMay 22, 2007
Enrollment StartMay 1, 2007
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.1 years ago
Interventions
Simvastatindrug
simvastatin 20 mg daily
Ezetimibe/Simvastatindrug
Ezetimibe (10mg)/Simvastatin (20mg)