A 12 Week Study of MK0653A in Patients Who Have Been Hospitalized for a Possible Heart Problem (0653A-808)

An Open-Label, Multicenter Study to Assess the Efficacy of Switching to a Combination Tablet Ezetimibe/Simvastatin 10mg/40mg, Compared to Doubling the Dose of Statin in Patients Hospitalized With a Coronary Event

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00132717

Enrollment

450

Registered

2005-08-22

Start date

2005-01-01

Completion date

2007-06-01

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

Brief summary

The purpose of this study is to investigate the effect of an investigational cholesterol-lowering drug in patients who are currently taking an approved medication for hypercholesterolemia (high cholesterol levels) and have been hospitalized for a heart problem.

Interventions

DRUGMK0653A (ezetimibe [+] simvastatin)

DRUGComparator: atorvastatin

DRUGComparator: fluvastatin

DRUGComparator: lovastatin

DRUGComparator: pravastatin

DRUGComparator: rosuvastatin

DRUGComparator: simvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients greater than 18 years old, who were admitted to a hospital for an investigation of a heart problem and are currently receiving an approved medication to lower cholesterol

Exclusion criteria

* Patients who have congestive heart failure (CHF), uncontrolled high blood pressure, poorly controlled blood sugar, impaired kidney function, or HIV.

Design outcomes

Primary

Measure	Time frame
Evaluate the effectiveness of MK0653A compared to doubling the statin dose as shown by the low-density lipoprotein cholesterol (LDL-C) values achieved after 12 weeks of treatment	After 12 weeks of treatment

Secondary

Measure	Time frame
To determine the effect of MK0653A compared to doubling the statin dose on total cholesterol (TC) after 12 weeks	After 12 weeks of treatment

Outcome results

None listed

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