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Comparison of Co-administration of Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Primary Hypercholesterolemia (P03476)

NCT00651274 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2024-08-15

No results posted yet for this study

Summary

This study will assess whether the daily co-administration of ezetimibe 10 mg with ongoing treatment of simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in further reducing LDL-C concentrations.

Conditions

Interventions

DRUG

Ezetimibe

oral tablets: ezetimibe 10 mg once daily for 6 weeks (plus continued simvastatin)

DRUG

Placebo

oral tablets: placebo to match ezetimibe 10 mg once daily for 6 weeks (plus continued simvastatin)

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
2003-04-01
Primary Completion
2004-08-01
Completion
2004-08-01

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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 NCT00651274 on ClinicalTrials.gov