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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)

Information source: Ironshore Pharmaceuticals and Development, Inc
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention-Deficit Hyperactivity Disorder

Intervention: HLD100-B (Drug); HLD100-C (Drug); HLD100-E (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Ironshore Pharmaceuticals and Development, Inc

Summary

The main purpose of this study is to determine the rate and extent of absorption of one or more modified release formulations of amphetamine (HLD100) in both adolescents and children with ADHD.

Clinical Details

Official title: A Phase II, Two-Stage, Open-Label, Single-Treatment, Adaptive Trial Design Examining the Pharmacokinetic and Pharmacodynamic Effects of up to Three Separate HLD100 Modified Release Formulations of Dextroamphetamine Sulfate in Adolescent (Stage 1) and Pediatric (Stage 2) Patients With Attention-Deficit Hyperactivity Disorder.

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Rate and Extent of absorption of d-amphetamine (AUC0-tz, AUC0-∞, Cmax, Tmax, absorption lag time, λz, and t1/2elim)

Secondary outcome: Safety (AEs, ECG, laboratory parameters, physical examinations)

Eligibility

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Main Inclusion Criteria

- Male and female adolescents (12-17 years; Stage 1) and children (6-11 years; Stage

2).

- Diagnosis of ADHD and confirmed on Kiddie-Schedule for Affective Disorders and

Schizophrenia (K-SADS).

- ADHD symptoms controlled on a stable dose of Vyvanse, Adderall XR and or Dexedrine.

- Provision of informed consent (from parent[s] or legal representative[s]) and assent

(from subject) for patients. Main Exclusion Criteria

- Comorbid psychiatric diagnosis (e. g., psychosis, bipolar disorder).

- History of seizures or current diagnosis or family history of Tourette's disorder.

- Use of prescription drugs (except Vyvanse, Dexedrine or Adderall XR) the 14 days and

over-the-counter drugs (except birth control) the 30 days before the study.

Locations and Contacts

Saskatoon Centre for Patient-Oriented Research, Royal University Hospital, Room 5681, C Wing, Saskatoon, Saskatchewan S7N 0W8, Canada
Additional Information

Starting date: July 2013
Last updated: October 2, 2014

Page last updated: August 20, 2015

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