NCT02476006
Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)
See it on ClinicalTrials.gov ↗994 people
37.1%
62.9%
369 womenmiddle line = equal numbers625 men
- Phase
- PHASE3
- Paid for by
- Sanofi
- Finished
- 2019-04-12
- Health conditions
- Hypercholesterolemia
- Who could join
- Anyone
- Ages
- 18 Years – no maximum
- Average age
- mean 56.6 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
- White 97.5% · Black / African American 1% · Other 0.8% · Asian 0.6% · More than one race 0.1%
Women left out
- No pregnant women
Women who were pregnant could not join.
“…t hepatitis B or C infection. Creatine kinase \>3 times the upper limit of normal. Estimated glomerular filtration rate \<30 mL/min/1.73 m\^2. Pregnant or breastfeeding woman or with childbearing potential without appropriate contraception.”
- No breastfeeding moms
Women who were breastfeeding could not join.
“…t hepatitis B or C infection. Creatine kinase \>3 times the upper limit of normal. Estimated glomerular filtration rate \<30 mL/min/1.73 m\^2. Pregnant or breastfeeding woman or with childbearing potential without appropriate contraception.”
- Had to use birth control
Women who couldn't or didn't want to use birth control were turned away.
“…t hepatitis B or C infection. Creatine kinase \>3 times the upper limit of normal. Estimated glomerular filtration rate \<30 mL/min/1.73 m\^2. Pregnant or breastfeeding woman or with childbearing potential without appropriate contraception.”
- No heart disease
Women with heart disease, heart rhythm problems or a past heart attack were turned away.
“New York Heart Association Class III or IV congestive heart failure persisting despite treatment.”
Study titles and rules are shown in their original English.