Observational Study to Evaluate LDL-C Lowering Effect of Ezetimibe - Tabular View

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

Tracking Information

First Received Date ^†

April 5, 2007

Last Updated Date

April 5, 2007

Start Date ^†

April 2005

Current Primary Outcome Measures ^†

Approval

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Observational Study to Evaluate LDL-C Lowering Effect of Ezetimibe

Official Title ^†

A Multicentre, Open-Label, Observational Local Study to Evaluate the LDL-C Lowering Effect of Ezetimibe as Prescribed in Daily Routine Practice in the South African Population

Brief Summary

To evaluate the LDL-C lowering in south african patients with primary hypercholesterolaemia after the addition of ezetimibe 10mg /day to ongoing therapy with a statin.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Hypercholesterolemia

Intervention ^†

Drug: MK0653, ezetimibe / Duration of Treatment: 4 Weeks

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

440

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Men or women >18 and <80 years of age
Patients receiving statin therapy for a minimum period of 6 weeks prior to visit 1
Female patients receiving hormone therapy (including hormone replacement therapy, any estrogen antagonist/agonist, or oral contraceptives) if maintained on a stable dose and regimen for at least 8 weeks prior to visit 1 and if willing to continue the same regimen throughout the study
Liver enzyme levels less than or equal to 1.5 times the upper limit of normal with no active liver disease and CPK less than or equal to 1.5 times upper limit of normal at visit 1

Exclusion Criteria:

Cardiovascular medications, such as beta-blockers, calcium-channel blockers, angiotensin ii receptor antagonists or anticoagulants (i.e., warfarin) unless treated with a stable regimen for at least 6 weeks prior to randomization and patient agrees to remain on constant regimen for the duration of the study
Patients on amiodarone hydrochloride will also be excluded
General weight less than 50% of ideal body weight according to the 1983 metropolitan height and weight tables or weighing less than 100 lbs (45 kg)
Hypersensitivity to HMG-COA reductase inhibitors
Patient has congestive heart failure defined by nyha class III or IV, uncontrolled cardiac arrhythmias, unstable angina pectoris, or myocardial infarction; coronary artery bypass surgery, or angioplasty within 3 months of visit 1
Taking lipid-lowering agents including fish oils, cholestin, bile-acid sequestrants and niacin (grater than 200 mg/day) taken within 6 weeks and fibrates taken within 8 weeks prior to visit 1
Taking medications that are potent inhibitors of cyp3a4, including cyclosporine, systemic itraconazole or ketoconazole, erythromycin or clarithromycin, nefazodone, verapamil and protease inhibitors
Consumption of greater than 250 ml of grapefruit juice/day
Taking oral corticosteroids unless used as replacement therapy for pituitary/adrenal disease and on a stable regimen for at least 6 weeks prior to visit 1
Treatment with psyllium, other fiber-based laxatives, and/or OTC therapies known to affect serum lipid levels, phytosterol margarines, unless treated with a stable regimen for at least 6 weeks prior to visit 1 and patient agrees to remain on constant regimen for the duration of the study
Women who are pregnant or lactating

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00457275

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Merck

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

April 2007

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