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Comparison of Ezetimibe Plus Simvastatin Versus Ezetimibe or Simvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03757)(COMPLETED)

NCT00650819 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2024-08-15

No results posted yet for this study

Summary

This is a multicenter, randomized, double blind; active-controlled parallel groups study enrolling subjects with primary hypercholesterolemia. Subjects receive ezetimibe, simvastatin, or the combination once daily for 8 weeks to determine the effect on LDL-cholesterol.

Conditions

Interventions

DRUG

Ezetimibe + Simvastatin

ezetimibe 10 mg plus simvastatin 20 mg once daily for 8 weeks

DRUG

Simvastatin

simvastatin 20 mg plus ezetimibe placebo once daily for 8 weeks

DRUG

Ezetimibe

Ezetimibe 10 mg plus simvastatin placebo once daily for 8 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
2004-06-01
Primary Completion
2005-02-01
Completion
2005-02-01

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Diseases
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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 NCT00650819 on ClinicalTrials.gov