Women were less than half of the people tested for almost all of these common medicines.
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NCT03375203

A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder

See it on ClinicalTrials.gov ↗

364 people

246 womenmiddle line = equal numbers118 men
Phase
PHASE2
Paid for by
Janssen Research & Development, LLC
Finished
2019-04-03
Health conditions
Insomnia Disorders
Who could join
Anyone
Ages
18 Years – 85 Years
Average age
mean 57.8 years
Age 65+
34.6%
Weight (BMI)
Not reported
Pregnancy recorded
Not reported
Menopause recorded
Not reported
Results shown by sex
Not split by sex
Race
White 69% · Black / African American 20.1% · Asian 8.2% · Native Hawaiian / Pacific Islander 1.1% · American Indian / Alaska Native 0.8% · Not reported 0.5% · More than one race 0.3%

Women left out

  • No pregnant women

    Women who were pregnant could not join.

    “Plans to father a child while enrolled in this study or within 3 months after the last dose of study drug; and/or, Is pregnant, or breastfeeding, while enrolled in this study or within 1 month after the last dose of study drug”
  • No breastfeeding moms

    Women who were breastfeeding could not join.

    “Plans to father a child while enrolled in this study or within 3 months after the last dose of study drug; and/or, Is pregnant, or breastfeeding, while enrolled in this study or within 1 month after the last dose of study drug”
  • Only women past menopause

    Women who could still get pregnant were turned away.

    “…, inclusive, on the day of signing informed consent. A WONCBP is defined as: a).Postmenopausal: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. b). Permanently sterile: Permanent sterilizat…”
  • No kidney or liver problems

    Women with kidney or liver problems were turned away.

    “…of or current clinically significant and/or unstable liver (moderate or severe hepatic impairment \[Child-Pugh Score {\>=} 7\]) or renal insufficiency (severe renal impairment \[estimated creatinine clearance below 30 {milliliter per minut…”
  • No heart disease

    Women with heart disease, heart rhythm problems or a past heart attack were turned away.

    “QT interval corrected according to Fridericia's formula: \>= 450 millisecond (msec) (males); \>= 470 msec (females).”
  • No diabetes

    Women with diabetes were turned away.

    “…chemistry, or urinalysis at screening. Participants with non-insulin dependent diabetes mellitus who are adequately controlled (hemoglobin A1c \[HbA1c\] =\< 8 percent \[%\]) may be eligible to participate if otherwise medically healthy. It…”
  • No seizures

    Women with epilepsy or past seizures were turned away.

    “…, rheumatologic, immunologic, or metabolic disturbances. Organic brain disease, epilepsy, dementia, narcolepsy, narrow angle glaucoma and known or suspected mental retardation are exclusionary. Any clinically relevant medical condition that…”
  • No mental health conditions

    Women with depression, bipolar disorder or other mental health conditions were turned away.

    “Has a current diagnosis or recent history of psychotic disorder, major depressive disorder (MDD), bipolar disorder, or posttraumatic stress disorder, or other psychiatric condition that, in the investigator's opinion, would interfere with t…”

Study titles and rules are shown in their original English.