NCT02839200
Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
See it on ClinicalTrials.gov ↗359 people
64.1%
35.9%
230 womenmiddle line = equal numbers129 men
- Phase
- PHASE2
- Paid for by
- Idorsia Pharmaceuticals Ltd.
- Finished
- 2017-06-20
- Health conditions
- Insomnia Disorder
- Who could join
- Anyone
- Ages
- 18 Years – 64 Years
- Average age
- median 47 years
- Age 65+
- 0%
- Weight (BMI)
- Not reported
- Pregnancy recorded
- Not reported
- Menopause recorded
- Not reported
- Results shown by sex
- Not split by sex
- Race
- White 89.4% · Black / African American 9.7% · Asian 0.3% · Native Hawaiian / Pacific Islander 0.3% · Not reported 0.3% · American Indian / Alaska Native 0% · More than one race 0%
Women left out
- Age limit under 65
Older women were turned away, even though they often take this medicine.
“Maximum age: 64 Years.”
- No pregnant women
Women who were pregnant could not join.
“Women of childbearing potential must have negative pregnancy tests and use reliable methods of contraception up to 30 days after EOT.”
- Had to use birth control
Women who couldn't or didn't want to use birth control were turned away.
“Women of childbearing potential must have negative pregnancy tests and use reliable methods of contraception up to 30 days after EOT.”
- Weight limit (BMI)
Women with a higher (or lower) body weight were turned away.
“Body mass index (BMI): 18.5 ≤ BMI (kg/m2) \< 32.0.”
Study titles and rules are shown in their original English.