NCT00763971
Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17
See it on ClinicalTrials.gov ↗332 people
19.3%
80.7%
64 womenmiddle line = equal numbers268 men
- Phase
- PHASE3
- Paid for by
- Shire
- Finished
- 2011-03-16
- Health conditions
- ADHD
- Who could join
- Anyone
- Ages
- 6 Years – 17 Years
- Average age
- mean 10.9 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
- Not reported
Women left out
- Age limit under 65
Older women were turned away, even though they often take this medicine.
“Maximum age: 17 Years.”
- Weight limit (BMI)
Women with a higher (or lower) body weight were turned away.
“Subject is significantly overweight based on Centre for Disease Control and Prevention Body Mass Index (BMI)-for-age gender specific charts at Screening. Significantly overweight is defined as a BMI \>97th percentile for this study.”
- No heart disease
Women with heart disease, heart rhythm problems or a past heart attack were turned away.
“Subject has a known history of symptomatic cardiovascular disease, advance arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that…”
- No seizures
Women with epilepsy or past seizures were turned away.
“Subject has a history of seizures (other than infantile febrile seizures), a tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.”
- No mental health conditions
Women with depression, bipolar disorder or other mental health conditions were turned away.
“Subject is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently, demonstrating active suicidal ideation.”
Study titles and rules are shown in their original English.