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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR INTUNIV

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Clinical Trials for Intuniv

Trial ID Title Status Sponsor Phase Summary
NCT00734578 Efficacy and Safety of SPD503 in Combination With Psychostimulants Completed Shire Phase 3 The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.
NCT00901576 A Drug Interaction Study of SPD503 and Concerta Administered Alone and In Combination in Normal Healthy Volunteers Completed Shire Phase 1 This is a drug-drug interaction study; the purpose of this study is to examine the pharmacokinetics (levels of drug in the blood) of SPD503 (guanfacine hydrochloride) and Concerta (methylphenidate HCl) when given alone, and in combination.
NCT00997984 Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study) Completed Shire Phase 3 The primary purpose is to assess the efficacy of once daily dosing with optimized SPD503 (1, 2, 3 and 4mg/day), dosed either in the morning or evening, compared to placebo, in children with ADHD as measured by change from baseline score at endpoint on the ADHD-RS-IV.
NCT01069523 Electrophysiological Effects of Guanfacine Extended Release in Attention Deficit Hyperactivity Disorder (ADHD) Completed Shire Phase 4 All subjects with the study will be children (age 6-12) with Attention Deficit Hyperactivity Disorder (ADHD). After baseline assessment confirms the presence of ADHD, children will have an Event related potential (ERP) (a type of electroencephalogram [EEG]) study. After the baseline EEG, children will be randomized to either placebo or GXR for a 4-week, parallel groups trial. During this trial, dosing will be flexibly adjusted according to patient response or presence of side effects. The dosage will range from 1-4 mg. At the end of the four week trial, a follow up ERP study will be obtained.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Intuniv

Condition Name

Condition Name for Intuniv
Intervention Trials
Attention Deficit Hyperactivity Disorder 6
Attention-Deficit/Hyperactivity Disorder 3
ADHD 2
Attention Deficit Disorder 1
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Condition MeSH

Condition MeSH for Intuniv
Intervention Trials
Attention Deficit Disorder with Hyperactivity 14
Hyperkinesis 10
Disease 10
Tourette Syndrome 1
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Clinical Trial Locations for Intuniv

Trials by Country

Trials by Country for Intuniv
Location Trials
United States 128
Canada 6
Poland 5
United Kingdom 4
Romania 3
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Trials by US State

Trials by US State for Intuniv
Location Trials
New York 8
Texas 7
Michigan 6
Florida 6
California 6
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Clinical Trial Progress for Intuniv

Clinical Trial Phase

Clinical Trial Phase for Intuniv
Clinical Trial Phase Trials
Phase 4 11
Phase 3 4
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Intuniv
Clinical Trial Phase Trials
Completed 13
Recruiting 3
Active, not recruiting 3
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Clinical Trial Sponsors for Intuniv

Sponsor Name

Sponsor Name for Intuniv
Sponsor Trials
Shire 13
Yale University 5
New York State Psychiatric Institute 3
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Sponsor Type

Sponsor Type for Intuniv
Sponsor Trials
Other 26
Industry 13
NIH 4
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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
McKinsey
Covington
Deloitte
Teva
Cantor Fitzgerald
Cipla
Farmers Insurance
Medtronic

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