NCT01886469 - A Phase II, Adaptive Trial Design Examining the Pharmacokinetic and Pharmacodynamic Effects of Modified Release Amphetamine (HLD100, Formulations B, C and E)) in Adolescents and Children With Attention-Deficit Hyperactivity Disorder (ADHD) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

September 30, 2013

Study Completion Date

September 30, 2013

Conditions

Attention-Deficit Hyperactivity Disorder

Interventions

DRUG

HLD100-B

d-amphetamine sulfate capsules, 30 mg, CII (25% SR, 30% pH coat, slow release; formulation B)

DRUG

HLD100-C

d-amphetamine sulfate capsules, 30 mg, CII (20% SR, 20% pH coat, fast release; formulation E) - this intervention may be deemed unnecessary based on results from Intervention 1.

DRUG

HLD100-E

d-amphetamine sulfate capsules, 30 mg, CII (20% SR, 20% pH coat, medium release; formulation E) - this intervention may be deemed unnecessary based on results from Interventions 1 and 2.

Trial Locations (1)

S7N 0W8

Saskatoon Centre for Patient-Oriented Research, Royal University Hospital, Room 5681, C Wing, Saskatoon