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Ezetimibe and Simvastatin in Primary Hypercholesterolemia, Diabetes Mellitus Type 2, and Coronary Heart Disease (COMPLETED)

NCT00423488 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2022-02-09

Study results available
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Summary

This multicenter, randomized, double-blind, placebo-controlled study will assess, after 6 weeks of dosing, whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be more effective than treatment with doubling the dose of simvastatin to 40 mg alone in reducing low-density lipoprotein-cholesterol (LDL-C) concentrations and in achieving the National Cholesterol Expert Panel (NCEP) III LDL-C target goal of \<2.6 mmol/L (\<100 mg/dL) for subjects with diabetes mellitus and coronary heart disease.

Conditions

Interventions

DRUG

Ezetimibe 10 mg

1 x 10-mg tablet, provided as blinded study treatment

DRUG

Simvastatin 20 mg

1 x 20-mg tablet, provided as open-label study treatment

DRUG

Ezetimibe Placebo

1 tablet matching ezetimibe 10-mg tablet, provided as blinded study treatment

DRUG

Simvastatin 20 mg

1 x 20-mg tablet, provided as blinded study treatment

DRUG

Simvastatin Placebo

1 tablet matching 20-mg simvastatin tablet, provided as blinded study treatment

Sponsors & Collaborators

  • Schering-Plough

    collaborator INDUSTRY

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-12
Primary Completion
2007-02-16
Completion
2007-02-16

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00423488 on ClinicalTrials.gov