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Ezetimibe Plus Atorvastatin Versus Atorvastatin in Untreated Subjects With Primary Hypercholesterolemia and Coronary Heart Disease (P03396)

NCT00650689 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2022-02-17

No results posted yet for this study

Summary

The primary objective is to evaluate the efficacy and safety of coadministration of ezetimibe 10 mg with atorvastatin 10 mg in untreated subjects with primary hypercholesterolemia and coronary heart disease for whom diet and exercise have failed. The primary variable is LDL-cholesterol (LDL-C), and the secondary variable is total cholesterol (TC), HDL-C, and triglycerides (TG). The following variables were used to assess the safety and compliance of the drug: vital signs and laboratory values. Variables were measured before the first administration of the drug and at the last administration of the drug, after 6 weeks of treatment. Adverse events were also assessed.

Conditions

Interventions

DRUG

Ezetimibe + Atorvastatin

oral tablets: ezetimibe 10 mg + atorvastatin 10 mg once daily for 6 weeks

DRUG

Atorvastatin

oral tablets: atorvastatin 10 mg + ezetimibe placebo once daily for 6 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
2003-05-31
Primary Completion
2004-12-31
Completion
2004-12-31

More Related Trials

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 NCT00650689 on ClinicalTrials.gov