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A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/20 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 20 mg Tablets in Participants With High Cholesterol (MK-0653C-185 AM1)

NCT01370590 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2022-02-09

Study results available
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Summary

The purpose of this study is to determine whether ezetimibe/atorvastatin 10 mg/20 mg combination tablet is equivalent to the coadministration of ezetimibe 10 mg and atorvastatin 20 mg in lowering low-density-lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.

Conditions

Interventions

DRUG

Atorvastatin

20 mg tablet administered orally once daily

DRUG

Ezetimibe

10 mg tablet administered orally once daily

DRUG

Ezetimibe/atorvastatin

Ezetimibe/atorvastatin 10 mg/20 mg combination tablet administered orally once daily

DRUG

Placebo to atorvastatin

Administered orally once daily

DRUG

Placebo to ezetimibe

Administered orally once daily

DRUG

Placebo to ezetimibe/atorvastatin

Administered orally once daily

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-04-30
Completion
2012-04-30

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Entities

Drugs
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 NCT01370590 on ClinicalTrials.gov