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Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)

NCT00871351 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2024-05-23

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose low-density lipoprotein (LDL)-cholesterol levels have not reached the lipid management target value with atorvastatin 10 mg alone, versus increasing the dose of atorvastatin to 20 mg or changing to rosuvastatin 2.5 mg.

Conditions

  • Primary Hypercholesterolemia

Interventions

DRUG

Ezetimibe

1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)

DRUG

Atorvastatin

1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)

DRUG

Atorvastatin

2 tablets of 10 mg daily for 12 weeks (Weeks 5-16)

DRUG

Rosuvastatin

1 tablet of 2.5 mg daily for 12 weeks (Weeks 5-16)

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-01
Primary Completion
2010-05-01
Completion
2010-05-01

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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 NCT00871351 on ClinicalTrials.gov