To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia

Official Title ^†

Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) Co-Administered in Patients With Type IIa or Type IIb Hyperlipidemia

Brief Summary

To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Part 1: Change in non-HDL-C; Part 2: Evaluate safety and tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measure ^†

Part 1: Change in other lipid variables; Part 2: Change in other lipid variables [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Condition ^†

Hypercholesterolemia

Intervention ^†

Drug: Comparator: ezetimibe/simvastatin + niacin (ER)
Drug: Comparator: Placebo to ezetimibe/simvastatin
Drug: Comparator: niacin (ER) tablet
Drug: Comparator: ezetimibe (+) simvastatin
Drug: Comparator: Placebo to Niacin (ER)

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

1220

Start Date ^†

December 2005

Completion Date

February 2008

Eligibility Criteria ^†

Inclusion Criteria:

Patient with LDL-C of 130 through 190 mg/dL and Triglycerides less than or equal to 500 mg/dL
Patient willing to be on a low-cholesterol diet

Exclusion Criteria:

Pregnant or lactating women or intending to become pregnant
Patient with sensitivity or intolerance to ezetimibe, simvastatin, or ezetimibe/simvastatin combination tablet
Patient with sensitivity or intolerance ro niacin, any component or niacin extended release or aspirin; Patient for whom discontinuation of existing lipid-lowering therapy treatment poses an unacceptable risk

Gender

Both

Ages

18 Years to 79 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Administrative Information Fields

NCT ID ^†

NCT00271817

Organization ID

2005_091

Secondary IDs ^††

MK0653A-091

Study Sponsor ^†

Merck

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

December 2008

First Received Date ^†

January 3, 2006

Last Updated Date

December 9, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.