Back to resultsTo Evaluate the Lipid-Lowering Efficacy and Safety of Simvastatin 40 Mg Tablet In Patients With Hypercholesterolemia (0733-264)
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
MK0733, simvastatin / Duration of Treatment: 12 Weeks
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- Male or female patient, >18 years of age
Patients with hypercholesterolemia who meet the following lipid criteria:
- primary cholesterolemia: total cholesterol>=240 mg/dl or ldl-c >= 160 mg/dl
- 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
Sites / Locations
- Merck Sharp & Dohme (I.A.) Corp.
Outcomes
Primary Outcome Measures
Total cholesterol, ldl-c, hdl-c, and triglycerides after 12 weeks
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00398294
Brief Title
To Evaluate the Lipid-Lowering Efficacy and Safety of Simvastatin 40 Mg Tablet In Patients With Hypercholesterolemia (0733-264)
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2005 (Actual)
Primary Completion Date
April 4, 2006 (Actual)
Study Completion Date
April 4, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
Brief Summary
To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients with hypercholesterolemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0733, simvastatin / Duration of Treatment: 12 Weeks
Primary Outcome Measure Information:
Title
Total cholesterol, ldl-c, hdl-c, and triglycerides after 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patient, >18 years of age
Patients with hypercholesterolemia who meet the following lipid criteria:
primary cholesterolemia: total cholesterol>=240 mg/dl or ldl-c >= 160 mg/dl
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Merck Sharp & Dohme (I.A.) Corp.
City
Taipei
ZIP/Postal Code
106
Country
Taiwan
12. IPD Sharing Statement
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
To Evaluate the Lipid-Lowering Efficacy and Safety of Simvastatin 40 Mg Tablet In Patients With Hypercholesterolemia (0733-264)
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