NCT01370590
A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/20 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 20 mg Tablets in Participants With High Cholesterol (MK-0653C-185 AM1)
See it on ClinicalTrials.gov ↗406 people
61.1%
38.9%
248 womenmiddle line = equal numbers158 men
- Phase
- PHASE3
- Paid for by
- Organon and Co
- Finished
- 2012-04
- Health conditions
- Hypercholesterolemia
- Who could join
- Anyone
- Ages
- 18 Years – 79 Years
- Average age
- Not reported
- Age 65+
- 17%
- Weight (BMI)
- Not reported
- Pregnancy recorded
- Not reported
- Menopause recorded
- Not reported
- Results shown by sex
- Not split by sex
- Race
- Not reported
Women left out
- No pregnant women
Women who were pregnant could not join.
“Is pregnant or lactating.”
- No breastfeeding moms
Women who were breastfeeding could not join.
“Is pregnant or lactating.”
- Had to use birth control
Women who couldn't or didn't want to use birth control were turned away.
“Female of reproductive potential agrees to remain abstinent or to use (or have their partner use) 2 acceptable methods of birth control throughout the study.”
- No kidney or liver problems
Women with kidney or liver problems were turned away.
“…pass, or other significant intestinal malabsorption; uncontrolled hypertension; kidney disease; disease known to influence serum lipids or lipoproteins; hematologic, digestive, or central nervous systems disorder; known to be human immunode…”
- No heart disease
Women with heart disease, heart rhythm problems or a past heart attack were turned away.
“Is high risk (according to NCEP ATP III guidelines), including but not limited to one or more of the following: diabetes mellitus (Type I or II), myocardial infarction, coronary artery bypass surgery, angioplasty, stable or unstable angina.”
- No diabetes
Women with diabetes were turned away.
“Is high risk (according to NCEP ATP III guidelines), including but not limited to one or more of the following: diabetes mellitus (Type I or II), myocardial infarction, coronary artery bypass surgery, angioplasty, stable or unstable angina.”
- No mental health conditions
Women with depression, bipolar disorder or other mental health conditions were turned away.
“…for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer; mental instability; drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy.”
- No cancer
Women with current or past cancer were turned away.
“…s disorder; known to be human immunodeficiency virus (HIV) positive; history of malignancy ≤5 years prior to the study, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer; mental instability; dr…”
Study titles and rules are shown in their original English.