NCT01239030
Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD
See it on ClinicalTrials.gov β230 people
33%
67%
76 womenmiddle line = equal numbers154 men
- Phase
- PHASE3
- Paid for by
- Rhodes Pharmaceuticals, L.P.
- Finished
- 2012-03
- Health conditions
- Attention Deficit Hyperactivity Disorder, ADHD
- Who could join
- Anyone
- Ages
- 6 Years β 18 Years
- Average age
- mean 10.8 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 68.7% Β· Black / African American 23% Β· Not reported 5.2% Β· Asian 1.3% Β· American Indian / Alaska Native 0.9% Β· Native Hawaiian / Pacific Islander 0.9% Β· More than one race 0%
Women left out
- Age limit under 65
Older women were turned away, even though they often take this medicine.
βMaximum age: 18 Years.β
- No pregnant women
Women who were pregnant could not join.
βIs pregnant or breast-feedingβ
- No breastfeeding moms
Women who were breastfeeding could not join.
βIs pregnant or breast-feedingβ
- Had to use birth control
Women who couldn't or didn't want to use birth control were turned away.
βFemales of child-bearing potential not pregnant and practice birth controlβ
- No seizures
Women with epilepsy or past seizures were turned away.
βChronic medical illnesses: seizure, hypertension, thyroid disease, cardiac, family history of sudden death, glaucomaβ
- No mental health conditions
Women with depression, bipolar disorder or other mental health conditions were turned away.
βCurrent primary psychiatric diagnosis of other listed disordersβ
Study titles and rules are shown in their original English.