Cholesterol Study
Principal Investigator: Edward Zawada, MD
Study Coordinator: Manjunath Balaram, CRC
Sub-Investigators: Julie Kittelsrud, CNP; Susan Weaver, CNP
Study Description: A study to evaluate the safety and effectiveness of MK-0653C (ezetimibe/atorvastatin in a combination tablet) compared to ezetimibe and atorvastatin in two separate tablets in patients with increased blood cholesterol levels.
Overview: The purpose of this clinical research study is to test the safety, tolerability and effectiveness of a new drug combination. The investigational combination therapy contains two drugs—ezetimibe and atorvastatin—that are individually available by prescription to treat high blood cholesterol levels. The combination tablet is considered experimental and has not yet been approved for sale.
Participation in this research study will involve about 6 clinic visits over a period of about 6 months. Participants will receive the following, at no cost: study-related medication, vital signs measurements, laboratory evaluations, EKG, and brief physical examinations. Study participants will be compensated for their time and travel.
Inclusion Criteria:
- Men and women between the ages of 18 and 80
- Is willing to maintain a cholesterol-lowering diet while participating in the study
- Either are not taking a cholesterol-lowering medication or are willing to take the study medications instead of their current medication
Exclusion Criteria:
- Women who are pregnant, breastfeeding or planning to become pregnant
- Has had a heart attack, angioplasty, angina, or coronary artery bypass surgery
- Has had gastric bypass
- Has been diagnosed with either Type I or Type II diabetes mellitus
- Has undergone LDL apheresis
- Has an uncontrolled endocrine or metabolic disease known to influence lipid or lipoprotein levels
- Routinely drinks more than 2 alcoholic drinks/day (average more than 14 alcoholic drinks/week)
Contact: Manjunath Balaram, CRC
Phone: (605) 322-3052
Email: manjunath.balaram@avera.org
