NCT00477204|CompletedPhase 2ResultsDMC
Clinical Trial of Zocor (Simvastatin) and Vytorin (Ezetimibe/Simvastatin) in Adolescents With Type 1 Diabetes
Clinical Trial of Zocor and Vytorin in Adolescents With Type 1 Diabetes
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Sponsor study identifier
Secondary identifiers
NIH
interventional
9
1 country
1
Study Start
May 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2010
Actual (reported)Study Completion
August 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2007
Date type not reportedThis date has not been verified as actual or estimated.
May 21, 2007
Actual (reported)May 22, 2007
Actual (reported)August 2010
Actual (reported)August 2010
Actual (reported)June 21, 2013
Actual (reported)Change in LDL-c From Baseline to 6 Months in Subjects With Type 1 Diabetes Taking Vytorin or Zocor.
Change in LDL-c between Zocor and Vytorin treatment in subjects with Type 1 Diabetes measured at baseline to the 6-month study visit.
Baseline to 6 months
Zocor(simvastatin)(20 mg)daily for 6 months along with Placebo (sugar pill)of active comparator (Vytorin \[simvastatin\] + Zetia \[ezetimibe\].
Vytorin(simvastatin \[Zocor} + ezetimibe \[Zetia\])(20 mg)daily for 6 months along with placebo (sugar pill)of comparator (Vytorin \[simvastatin\]).
simvastatin 20 mg daily
Ezetimibe (10mg)/Simvastatin (20mg)
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Ezetimibe/Simvastatin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordBarbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045, United States
Recruitment for this study failed to meet target and therefore it is difficult to make conclusions on the data obtained in these 9 subjects. No secondary outcomes were measured as recruitment was insufficient and study was stopped after only 9 subjects completed trial.
David M Maahs, MD
University of Colorado, Denver
R. P Wadwa, MD
University of Colorado, Denver
9 participants (actual enrollment reported by the registry).
First Submitted
May 21, 2007
First Posted
May 22, 2007
Study Start
May 2007
Date type not reportedThis date has not been verified as actual or estimated.
Atorvastatin in New Onset Type 1 Diabetes Mellitus (T1DM)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
August 2010
Actual (reported)Study Completion
August 2010
Actual (reported)Last Updated
November 10, 2020
Results First Posted
June 21, 2013
Record last verified: 2020-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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