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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00457275
First received: April 5, 2007
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia
Drug: MK0653, ezetimibe / Duration of Treatment: 4 Weeks
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Approval

Estimated Enrollment: 440
Study Start Date: April 2005
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457275

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00457275     History of Changes
Other Study ID Numbers: 0653-070, 2007_012
Study First Received: April 5, 2007
Last Updated: May 29, 2014
Health Authority: South Africa: Medicines Control Council

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Anticholesteremic Agents
Antimetabolites
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014