Status:
COMPLETED
To Evaluate the Lipid-Lowering Efficacy and Safety of Simvastatin 40 Mg Tablet In Patients With Hypercholesterolemia (0733-264)
Lead Sponsor:
Organon and Co
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients with hypercholesterolemia.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00398294
Start Date
May 1 2005
End Date
April 4 2006
Last Update
August 15 2024
Active Locations (1)
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1
Merck Sharp & Dohme (I.A.) Corp.
Taipei, Taiwan, 106