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Clinical Trials/NCT00389896
NCT00389896
Completed
Phase 3

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Balanced, Three-Way Crossover Study to Evaluate the Efficacy of Simvastatin Therapy in Elevating HDL-C Levels in Patients With Type 2 Diabetic Dyslipidemia and Low HDL-C

Organon and Co0 sites150 target enrollmentJuly 26, 2001
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ConditionsHDL Cholesterol
DrugsMK0733 / Duration of Treatment: 18 WeeksComparator: placebo (unspecified) / Duration of Treatment: 18 Weeks

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
HDL Cholesterol
Sponsor
Organon and Co
Enrollment
150
Primary Endpoint
HDL-C raising effects after 6 weeks
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

The purpose of this study is to see how well simvastatin raises HDL levels in patients with Type 2 Diabetes.

Registry
clinicaltrials.gov
Start Date
July 26, 2001
End Date
October 4, 2002
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Patient has stable Type 2 diabetes mellitus at Visit
  • •Patient meets screening criteria based on Visit 1 lab tests

Exclusion Criteria

  • •Patient is pregnant, breastfeeding, or at risk of becoming pregnant
  • •Patient has heart disease, uncontrolled high blood pressure, or other significant disease
  • •Patient is taking prohibited medication(s) and is unable to stop taking them for the duration of the study

Outcomes

Primary Outcomes

HDL-C raising effects after 6 weeks

Time Frame: 6 weeks

Secondary Outcomes

  • Effect on other lipids and lipoproteins at 6 weeks(6 weeks)

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