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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00398294
First Posted: November 10, 2006
Last Update Posted: April 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients with hypercholesterolemia.

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

Study Type: Interventional
Study Design: 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

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
Actual Study Start Date: May 1, 2005
Study Completion Date: April 4, 2006
Primary Completion Date: April 4, 2006 (Final data collection date for primary outcome measure)
  Eligibility

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
  Contacts and Locations
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.
  More Information

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 Submitted: November 9, 2006
First Posted: November 10, 2006
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