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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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00398294
First received: November 9, 2006
Last updated: November 12, 2014
Last verified: November 2014
  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
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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00398294     History of Changes
Other Study ID Numbers: 0733-264, 2006_044
Study First Received: November 9, 2006
Last Updated: November 12, 2014
Health Authority: Taiwan: National Bureau of Controlled Drugs

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

ClinicalTrials.gov processed this record on November 27, 2014