An Extension Study of An Investigational Drug in Patients With Hypercholesterolemia (0653A-038)(COMPLETED)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Factorial Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet in Patients With Primary Hypercholesterolemia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092664

Enrollment

1104

Registered

2004-09-28

Start date

2003-01-31

Completion date

2003-09-30

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

Primary hypercholesterolemia

Brief summary

The purpose of this study is to evaluate the lipid lowering effects of an investigational drug in patients with hypercholesterolemia (high cholesterol).

Interventions

DRUGMK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 14 weeks

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* High cholesterol

Exclusion criteria

* Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.

Design outcomes

Primary

Measure	Time frame
Plasma LDL-C.	—

Secondary

Measure	Time frame
Plasma TG and HDL-C; proportion of patients achieving LDL-C targets; tolerability.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026