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NCT00477204 · ClinicalTrials.gov registry record · Phase 2

Clinical Trial of Zocor (Simvastatin) and Vytorin (Ezetimibe/Simvastatin) in Adolescents With Type 1 Diabetes

A Phase 2 study, sponsored by University of Colorado, Denver.

Completed
Registry status
Phase 2
Development phase
9
Enrollment target

NCT00477204: Completed Phase 2 study, sponsored by University of Colorado, Denver.

NCT00477204 is a Phase 2 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00477204, a Phase 2 study, has completed, sponsored by University of Colorado, Denver.

COMPLETED
Registry status
Phase 2
Development phase
9 participants
Enrollment target

Study 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.

Primary Outcome

Change in LDL-c between Zocor and Vytorin treatment in subjects with Type 1 Diabetes measured at baseline to the 6-month study visit.

Interventions

  • DRUG Simvastatin
  • DRUG Ezetimibe/Simvastatin

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2007-05
Est. Completion 2010-08
Phase Phase 2
University of Colorado, Denver

1,283 total trials

What the finished NCT00477204 record still lists

NCT00477204 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 2 interventions - of which Simvastatin is the first listed.

NCT00477204 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00477204 about?

NCT00477204 is a clinical study titled "Clinical Trial of Zocor (Simvastatin) and Vytorin (Ezetimibe/Simvastatin) in Adolescents With Type 1 Diabetes". 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 Diabet...

What is the current status of trial NCT00477204?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2007-05. Estimated completion is 2010-08.

What interventions are being tested in trial NCT00477204?

The interventions under investigation include: Simvastatin (DRUG), Ezetimibe/Simvastatin (DRUG).

Who is sponsoring clinical trial NCT00477204?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00477204's enrollment target sits among peer trials

9 1989th of 2000 higher than 11 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00477204, the US trial registry maintained by the National Library of Medicine. NCT00477204 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.