A Study of MK0653A (Ezetimibe (+) Simvastatin) in Patients With Hypercholesterolemia (0653A-038)

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

NCT00092651

Enrollment

1398

Registered

2004-09-28

Start date

2002-09-30

Completion date

2003-06-30

Last updated

2024-08-23

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).

Detailed description

The duration of treatment is 4 months.

Interventions

DRUGMK0653A, ezetimibe (+) simvastatin

DRUGComparators: simvastatin and ezetimibe

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

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	From baseline to study end point, defined in this study as the last available postbaseline LDL-C measurement, after 12 weeks of treatment.

Secondary

Measure	Time frame
Plasma LDL-C, TG and HDL-C. The proportion of patients achieving LDL-C targets. Tolerability.	From baseline to study end point in TC, TG, HDL-C, ratios of direct LDL-C:HDL-C and TC:HDL-C, non-HDL-C, Apo B, Apo A-I, Apo A-II, Apo E, lipoprotein(a), C[1]reactive protein (CRP), and fibrinogen, after 12 weeks of treatment.

Outcome results

None listed

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