Observational Study to Evaluate LDL-C Lowering Effect of Ezetimibe (0653-070)

February 7, 2022 updated by: Organon and Co

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

440

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Approval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

April 5, 2007

First Submitted That Met QC Criteria

April 5, 2007

First Posted (Estimate)

April 6, 2007

Study Record Updates

Last Update Posted (Actual)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0653-070
  • 2007_012

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis Link

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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