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)
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ClinicalTrials.gov Identifier: NCT01886469 |
Recruitment Status :
Completed
First Posted : June 26, 2013
Last Update Posted : October 3, 2014
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Sponsor:
Ironshore Pharmaceuticals and Development, Inc
Information provided by (Responsible Party):
Ironshore Pharmaceuticals and Development, Inc
Tracking Information | |||
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First Submitted Date ICMJE | June 21, 2013 | ||
First Posted Date ICMJE | June 26, 2013 | ||
Last Update Posted Date | October 3, 2014 | ||
Study Start Date ICMJE | July 2013 | ||
Actual Primary Completion Date | September 2013 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Rate and Extent of absorption of d-amphetamine (AUC0-tz, AUC0-∞, Cmax, Tmax, absorption lag time, λz, and t1/2elim) [ Time Frame: 48hrs ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
Safety (AEs, ECG, laboratory parameters, physical examinations) [ Time Frame: 48 hours ] | ||
Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | 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) | ||
Official Title ICMJE | 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. | ||
Brief 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. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Attention-Deficit Hyperactivity Disorder | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
22 | ||
Original Estimated Enrollment ICMJE |
96 | ||
Actual Study Completion Date ICMJE | September 2013 | ||
Actual Primary Completion Date | September 2013 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Main Inclusion Criteria
Main Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 6 Years to 17 Years (Child) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Canada | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01886469 | ||
Other Study ID Numbers ICMJE | HLD100-102 HLD100-102 (Control # 163513) ( Other Identifier: Health Canada ) |
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Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Ironshore Pharmaceuticals and Development, Inc | ||
Study Sponsor ICMJE | Ironshore Pharmaceuticals and Development, Inc | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Ironshore Pharmaceuticals and Development, Inc | ||
Verification Date | September 2014 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |