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

NCT00457275 | Completed Phase 3

• 2 other identifiers: 0653-0702007_012
• Study Type: interventional
• Target: 440
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Approval

Interventions

MK0653, ezetimibe / Duration of Treatment: 4 Weeks DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Raal F, Schamroth C, Patel J, Becker P. A multicentre, open-label, observational local study to evaluate the low-density lipoprotein cholesterol-lowering effect of ezetimibe as prescribed in daily routine practice in the South African population. Cardiovasc J Afr. 2007 Sep-Oct;18(5):325-9.

  PMID: 17985033 RESULT

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Ezetimibe; Duration of Therapy

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2007
• First Posted: April 6, 2007
• Study Start: April 1, 2005
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: August 15, 2024

Record last verified: 2022-02