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To Evaluate the Lipid-Lowering Efficacy and Safety of Simvastatin 40 Mg Tablet In Patients With Hypercholesterolemia (0733-264)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: November 9, 2006
Last updated: October 21, 2015
Last verified: October 2015
To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients with hypercholesterolemia.

Condition Intervention Phase
Drug: MK0733, simvastatin / Duration of Treatment: 12 Weeks
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Arm, Prospective Study to Evaluate the Lipid-Lowering Efficacy and Safety of Simvastatin 40 Mg Tablet in Patients With Hypercholesterolemia

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Total cholesterol, ldl-c, hdl-c, and triglycerides after 12 weeks

Enrollment: 30
Study Start Date: May 2005
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female patient, >18 years of age
  • Patients with hypercholesterolemia who meet the following lipid criteria:

    1. primary cholesterolemia: total cholesterol>=240 mg/dl or ldl-c >= 160 mg/dl
    2. secondary cholesterolemia (patients with cad, dm): ldl-c>=130 mg/dl
  • The patient is willing to follow an NCEP therapeutic lifestyle changes (tlc) or similar cholesterol-lowering diet throughout the duration of the study

Exclusion Criteria:

  • Congestive heart failure (NYHA class III or IV), uncontrolled cardiac arrhythmias, unstable angina pectoris
  • Myocardial infarction, coronary artery bypass surgery, or angioplasty within 3 months of visit 1
  • Uncontrolled hypertension with systolic blood pressure > 160 mmhg or diastolic > 100 mmhg at visit 1.
  • Unstable diabetes (hba1c >9%) or newly diagnosed (within 3 months)or change in anti-diabetes medications within 3 months of screening
  Contacts and Locations
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Please refer to this study by its identifier: NCT00398294

Merck Sharp & Dohme (I.A.) Corp.
Taipei, Taiwan, 106
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00398294     History of Changes
Other Study ID Numbers: 0733-264  2006_044 
Study First Received: November 9, 2006
Last Updated: October 21, 2015
Health Authority: Taiwan: National Bureau of Controlled Drugs

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on October 21, 2016