Efficacy of Ezetimibe/Simvastatin 10/20 mg and MK0524A (1-2 g/Day) in Mixed Hyperlipidemia and Two or More Risk Factors

Efficacy of Ezetimibe/Simvastatin 10/20 mg and MK0524A (1-2 g/Day) in Patients With Mixed Hyperlipidemia and Two or More Risk Factors to Cardiovascular Disease.

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00738985

Enrollment

Registered

2008-08-21

Start date

2009-11-30

Completion date

2010-09-30

Last updated

2015-03-24

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

Conditions

Cardiovascular Diseases, Hyperlipidemia

Brief summary

To measure the percentage of patients who achieve all the treatment lipid goals being treated with ezetimibe/simvastatin 10/20 with or without MK0524A (1-2 g/day).

Detailed description

Patients will receive placebo for 4 weeks, then Vytorin 10/20 mg for 6 weeks, if efficacy of treatment is achieved, they will continue with Vytorin 10/20 mg + placebo for 12 more weeks, if not achieved, will receive Vytorin 10/20 mg + MK0524A 1 gr for 6 weeks, if efficacy achieved will continue with Vytorin 10/20 mg + MK0524A 1 gr + placebo; if not achieved, will receive Vytorin 10/20 mg + MK0524A 2 gr for 6 weeks.

Interventions

DRUGezetimibe/simvastatin 10/20 mg + placebo

Patients will receive placebo (sugar tablets) for up to 22 weeks.

DRUGezetimibe/simvastatin 10/20 mg + MK0524A

ezetimibe (+) simvastatin 10/20 mg for 18 weeks. Tablets

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

* Patient Without Ischemic Cardiovascular Disease Who During The Treatment With Statin Have LDL-C \<130 Mg/Dl at Visit 1 Or Within The 6 Month Period Before Visit 1

Exclusion criteria

* The use of any other lipid lowering agent * Life expectancy lower than a year. * Any condition that may interfere with the adherence to the study protocol

Design outcomes

Primary

Measure	Time frame
Lipid parameters efficacy comparing ezetimibe/simvastatin alone vs. ezetimibe/simvastatin plus MK0524A (CORDAPTIVE)	18 Week(s)

Outcome results

None listed

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