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Effects of Vytorin Versus Placebo in Subjects With Primary Hypercholesterolemia (Study P04420)

NCT00413972 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2022-02-09

Study results available
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Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3 study of Vytorin 10/10 (ezetimibe 10 mg with simvastatin 10 mg), Vytorin 10/20 (ezetimibe 10 mg with simvastatin 20 mg), and Vytorin 10/40 (ezetimibe 10 mg with simvastatin 40 mg) compared to placebo administered daily for 8 consecutive weeks in subjects with primary hypercholesterolemia (LDL-C \>3.64 mmol/L \[140 mg/dL\]). The efficacy of daily Vytorin versus placebo in reducing the concentration of LDL-C will be evaluated, and the efficacy of daily Vytorin versus placebo with respect to change in the concentrations of total cholesterol, triglycerides, and HDL-C will be compared. The safety of Vytorin versus placebo will also be assessed.

Conditions

Interventions

DRUG

ezetimibe with simvastatin

Ezetimibe 10 mg with Simvastatin 10 mg once daily for a total of eight weeks

DRUG

Ezetimibe with Simvastatin

Ezetimibe 10 mg with Simvastatin 20 mg once daily for a total of eight weeks

DRUG

Ezetimibe with Simvastatin

Ezetimibe 10 mg with Simvastatin 40 mg once daily for a total of eight weeks

DRUG

Placebo

Placebo once daily for a total of eight weeks

Sponsors & Collaborators

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
2006-04-30
Primary Completion
2006-11-30
Completion
2006-11-30

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Entities

Drugs
Diseases
Companies

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 NCT00413972 on ClinicalTrials.gov