NCT03768427
Ezetimibe (EZ)/Atorvastatin (Ator) (MK-0653C) vs. Ator in Chinese Hypercholesterolemic Participants (MK-0653C-439)
See it on ClinicalTrials.gov ↗454 people
35.5%
64.5%
161 womenmiddle line = equal numbers293 men
- Phase
- PHASE3
- Paid for by
- Organon and Co
- Finished
- 2021-04-01
- Health conditions
- Hypercholesterolemia
- Who could join
- Anyone
- Ages
- 18 Years – 80 Years
- Average age
- mean 60.9 Years
- Age 65+
- Not reported
- Weight (BMI)
- Not reported
- Pregnancy recorded
- Not reported
- Menopause recorded
- Not reported
- Results shown by sex
- Not split by sex
- Race
- Asian 100% · American Indian / Alaska Native 0% · Native Hawaiian / Pacific Islander 0% · Black / African American 0% · White 0% · More than one race 0% · Not reported 0%
Women left out
- No pregnant women
Women who were pregnant could not join.
“Is a WOCBP who has had a positive urine pregnancy test within 24 hours before the first dose of study intervention. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.”
- No women who could get pregnant
Most women roughly 15–50 years old were turned away.
“Is a WOCBP who has had a positive urine pregnancy test within 24 hours before the first dose of study intervention. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.”
- Had to use birth control
Women who couldn't or didn't want to use birth control were turned away.
“If female, is not pregnant or breastfeeding, and is either not a woman of childbearing potential (WOCBP), or is a WOCBP who has used a contraceptive consistent with local regulations.”
- No hormonal birth control
Women on the pill, patch, ring, shot, implant or hormonal IUD could not join.
“Is taking any cyclical hormones (e.g., cyclical oral contraceptives, cyclical hormone replacement), including the combination of ethinyl estradiol and norethisterone, or non-cyclical hormones, including non-cyclical hormone replacement ther…”
- No hormone therapy
Women taking menopause hormones or gender-affirming hormones could not join.
“Is taking any cyclical hormones (e.g., cyclical oral contraceptives, cyclical hormone replacement), including the combination of ethinyl estradiol and norethisterone, or non-cyclical hormones, including non-cyclical hormone replacement ther…”
- No kidney or liver problems
Women with kidney or liver problems were turned away.
“Has active liver disease”
- No heart disease
Women with heart disease, heart rhythm problems or a past heart attack were turned away.
“Has New York Heart Association (NYHA) Class III or IV symptomatic congestive heart failure at Visit 1.”
- No mental health conditions
Women with depression, bipolar disorder or other mental health conditions were turned away.
“Has a history of 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.
“Has a history of cancer within the past 5 years from Visit 1 (except for successfully treated dermatological basal cell or squamous cell carcinoma or in situ cervical cancer).”
Study titles and rules are shown in their original English.