NCT00492232
Facilitation of Zolpidem (≥10 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia
See it on ClinicalTrials.gov ↗135 people
67.4%
32.6%
91 womenmiddle line = equal numbers44 men
- Phase
- PHASE4
- Paid for by
- Takeda
- Finished
- 2008-05
- Health conditions
- Chronic Insomnia
- Who could join
- Anyone
- Ages
- 18 Years – no maximum
- Average age
- mean 49.2 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 87.4% · Black / African American 10.4% · Asian 1.5% · More than one race 0.7%
Women left out
- Had to use birth control
Women who couldn't or didn't want to use birth control were turned away.
“Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.”
- Weight limit (BMI)
Women with a higher (or lower) body weight were turned away.
“Body mass index of less than 18 or greater than 34 (weight /height2).”
- No seizures
Women with epilepsy or past seizures were turned away.
“History of fibromyalgia, history of seizures, sleep apnea, restless leg syndrome, periodic leg syndrome, chronic obstructive pulmonary disease, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.”
- No mental health conditions
Women with depression, bipolar disorder or other mental health conditions were turned away.
“History of fibromyalgia, history of seizures, sleep apnea, restless leg syndrome, periodic leg syndrome, chronic obstructive pulmonary disease, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.”
Study titles and rules are shown in their original English.