Study Evaluating the Efficacy and Safety of Simvastatin Alone Compared With Simvastatin Plus Ezetimibe in Type 2 Diabetic Patients (0653-021)(COMPLETED)

February 7, 2022 updated by: Organon and Co

A Randomized, Double-Blind, Parallel, Multicenter Study to Evaluate the Efficacy and Safety of Simvastatin Monotherapy Compared With Simvastatin Plus Ezetimibe (SCH 58235) in Type 2 Diabetic Patients Treated With Thiazolidinediones

The purpose of this study is to determine if the addition of ezetimibe 10 mg daily to ongoing 20 mg simvastatin daily will reduce LDL Cholesterol to a greater extent than increasing the dose of simvastatin to 40 mg daily in Type 2 diabetics treated with Thiazolidinediones (TZD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

214

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women age between 30 and 75 with Type 2 diabetes mellitus who are treated with pioglitazone or rosiglitazone
  • Additionally, patients must have an LDL-C >100 mg/dL at Visit 1 or prior to initiation of statin therapy

Exclusion Criteria:

  • Patients taking sliding scale insulin, selected lipid lowering medications, oral anticoagulants and cyclical sex hormones
  • Patients with heart disease, kidney disease, liver disease, uncontrolled high blood pressure, and insulin dependent diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change in fasting LDL-C from baseline to the average of the Week 6/Week 12 measurements
Time Frame: 6 & 12 Weeks
6 & 12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Well tolerated in patients in Diabetic patients
Time Frame: 30 Weeks
30 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (Actual)

January 1, 2003

Study Completion (Actual)

January 1, 2003

Study Registration Dates

First Submitted

October 29, 2007

First Submitted That Met QC Criteria

October 29, 2007

First Posted (Estimate)

October 31, 2007

Study Record Updates

Last Update Posted (Actual)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0653-021
  • MK0653-021
  • 2006_554

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis Link

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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