Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial (0653-151)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00652444
First received: March 31, 2008
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

The primary outcome was percentage reduction of LDL-C after 6 weeks of randomization.


Condition Intervention Phase
Hypercholesterolemia
Drug: ezetimibe
Drug: simvastatin
Drug: Placebo (Unspecified)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage reduction of LDL-C after 6 weeks of treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: September 2003
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Coadministration arm: simvastatin 20mg and ezetimibe 10mg
Drug: ezetimibe
ezetimibe 10mg. Blood samples were collected again at the end of study treatment, week 6.
Other Names:
  • Zetia®
  • EZETROL®
  • MK0653
Drug: simvastatin
simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.
Other Names:
  • Zocor®
  • MK0733
Experimental: 2
Monotherapy arm: simvastatin 20mg and ezetimibe placebo
Drug: simvastatin
simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.
Other Names:
  • Zocor®
  • MK0733
Drug: Placebo (Unspecified)
Matching ezetimibe placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with known Coronary Artery Disease (CAD) and primary hypercholesterolemia, who are being treated with simvastatin 20mg. Simvastatin consumption meant that subjects must be currently taking simvastatin 20mg daily, and by history have taken at least 80% of daily evening doses for the preceding 6 weeks prior to baseline visit
  • Age of at least 18 years and 75 years or less
  • Calculated LDL-C concentration of at least 2.6 and 4.1mmol/l or less using the Friedewald equation, and triglyceride of less than 3.99 mmol/l

Exclusion Criteria:

  • Congestive heart failure (defined as New York Heart Association class III or IV heart failure)
  • Uncontrolled cardiac arrhythmias
  • Acute coronary syndrome, coronary bypass surgery or coronary angioplasty within 3 months of study entry
  • History of unstable or severe peripheral artery disease within 3 months of study entry
  • Uncontrolled hypertension at study entry
  • Uncontrolled or newly diagnosed diabetes mellitus (within 3 months of study entry)
  • Uncontrolled endocrine or metabolic diseases known to influence serum lipids and lipoproteins; known impairment of renal function
  • Active or chronic hepatic and hepatobiliary disease
  • Disorders that would limit study evaluation or participation
  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: NCT00652444

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00652444     History of Changes
Other Study ID Numbers: 0653-151, 2008_004
Study First Received: March 31, 2008
Last Updated: May 8, 2014
Health Authority: United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health

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

ClinicalTrials.gov processed this record on October 19, 2014