Clinical Trial of Zocor (Simvastatin) and Vytorin (Ezetimibe/Simvastatin) in Adolescents With Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT00477204|
Recruitment Status : Completed
First Posted : May 22, 2007
Results First Posted : June 21, 2013
Last Update Posted : August 28, 2013
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus Dyslipidemia||Drug: Simvastatin Drug: Ezetimibe/Simvastatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Clinical Trial of Zocor and Vytorin in Adolescents With Type 1 Diabetes|
|Study Start Date :||May 2007|
|Primary Completion Date :||August 2010|
|Study Completion Date :||August 2010|
Active Comparator: Simvastatin
Zocor(simvastatin)(20 mg)daily for 6 months along with Placebo (sugar pill)of active comparator (Vytorin [simvastatin] + Zetia [ezetimibe].
simvastatin 20 mg daily
Other Name: Zocor
Active Comparator: Ezetimibe/Simvastatin
Vytorin(simvastatin [Zocor} + ezetimibe [Zetia])(20 mg)daily for 6 months along with placebo (sugar pill)of comparator (Vytorin [simvastatin]).
Ezetimibe (10mg)/Simvastatin (20mg)
Other Name: Vytorin
- Change in LDL-c From Baseline to 6 Months in Subjects With Type 1 Diabetes Taking Vytorin or Zocor. [ Time Frame: Baseline to 6 months ]Change in LDL-c between Zocor and Vytorin treatment in subjects with Type 1 Diabetes measured at baseline to the 6-month study visit.
- No Secondary Outcomes [ Time Frame: 6 months ]No secondary outcomes were measured as recruitment was insufficient and study was stopped after only 9 subjects completed trial.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00477204
|United States, Colorado|
|Barbara Davis Center for Childhood Diabetes|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||David M Maahs, MD||University of Colorado, Denver|
|Principal Investigator:||R. P Wadwa, MD||University of Colorado, Denver|