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

This study has been withdrawn prior to enrollment.

(The study was cancelled due to budget limitations)

Sponsor:

Collaborator:

Merck

Information provided by:

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

ClinicalTrials.gov Identifier:

NCT00738985

First received: August 19, 2008

Last updated: October 21, 2011

Last verified: September 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

August 19, 2008

Last Updated Date

October 21, 2011

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Lipid parameters efficacy comparing ezetimibe/simvastatin alone vs. ezetimibe/simvastatin plus MK0524A (CORDAPTIVE) [ Time Frame: 18 Week(s) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00738985 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Cardiovascular Diseases
Hyperlipidemia

Intervention ^ICMJE

Drug: ezetimibe/simvastatin 10/20 mg + placebo
Patients will receive placebo (sugar tablets) for up to 22 weeks.

Other Name: No other drug is used per protocol in this study arm
Drug: ezetimibe/simvastatin 10/20 mg + MK0524A
ezetimibe (+) simvastatin 10/20 mg for 18 weeks. Tablets
Other Names:
- Vytorin
- MK0653A

Study Arm (s)

Placebo Comparator: ezetimibe/simvastatin 10/20 mg + placebo
The intervention consisted of an isocaloric diet, an exercise program (30 min/day of aerobic activity) and ezetimibe (+) simvastatin 10/20 mg + placebo for 12 weeks. Safety and efficacy parameters are measured at baseline and 12 weeks later

Intervention: Drug: ezetimibe/simvastatin 10/20 mg + placebo
Active Comparator: ezetimibe/simvastatin 10/20 mg + MK0524A
The intervention consisted of an isocaloric diet, an exercise program (30 min/day of aerobic activity) and ezetimibe/simvastatin 10/20 mg + MK0524A 1 gr for 6 weeks, if efficacy achieved will continue with ezetimibe (+) simvastatin 10/20 mg + MK0524A 1 gr + placebo; if not achieved, will receive ezetimibe (+) simvastatin 10/20 mg + MK0524A 2 gr for 6 weeks.

Intervention: Drug: ezetimibe/simvastatin 10/20 mg + MK0524A

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

September 2010

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00738985

Other Study ID Numbers ^ICMJE

2008_019

Has Data Monitoring Committee

Responsible Party

Carlos A Aguilar Salinas, Instituto Nacional de Ciencias Medicas y Nutricion

Study Sponsor ^ICMJE

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Collaborators ^ICMJE

Merck

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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