Clinical Trial of Zocor (Simvastatin) and Vytorin (Ezetimibe/Simvastatin) in Adolescents With Type 1 Diabetes
|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|
|Actual Primary Completion Date :||August 2010|
|Actual 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.
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|