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

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ClinicalTrials.gov Identifier: NCT00398294
Recruitment Status : Completed
First Posted : November 10, 2006
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients with hypercholesterolemia.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: MK0733, simvastatin / Duration of Treatment: 12 Weeks Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : May 1, 2005
Primary Completion Date : April 4, 2006
Study Completion Date : April 4, 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin
U.S. FDA Resources




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00398294


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

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00398294     History of Changes
Other Study ID Numbers: 0733-264
2006_044
First Posted: November 10, 2006    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017

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