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The study was cancelled prior to the enrollment of any participants.
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This 6-week study is to determine if the study drug, Methylphenidate Hydrochloride (HCl) Extended-Release Chewable Tablets (ERCT), is safe, tolerable and effective when compared to a sugar pill or placebo in children 4 to 5 years of age with ADHD.
Phase 4 Double-blind, Randomized, Parallel Group, Placebo-controlled Study of the Efficacy And Safety of Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablets (ERCT) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (ADHD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | one chewable tablet once daily in morning. |
|
| Methylphenidate Hydrochloride Extended Release Chewable Tablet | Experimental | one chewable tablet once daily in morning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT) | Drug | Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version | Change from Baseline to end of double-blind treatment in the total score of the Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version | Basline, 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety-incidence of treatment emergent adverse events | incidence of treatment emergent adverse events | 6 Weeks |
| Change from Baseline in Clinical Global Impression - Severity (CGI-S) score | The CGI-S is a one-item scale for the clinician to assess their impression of the severity of a subject's current state of illness relative to clinician's past experience with patients who have the same diagnosis. A subject's severity of mental illness is assessed considering a clinician's total clinical experience using a scale from 1 to 7 defined as: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
| To obtain contact information for a study center near you, click here. | View source |
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Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Double-blind, placebo-controlled, parallel group study.
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Double-blind
| Placebo | Drug | Placebo |
|
| Baseline, Weeks 1 through 6 |
| Change from Baseline in Clinical Global Impression of Improvement (CGI-I) Scale Score | The CGI-I is a one-item scale to compare the subject's current condition to the condition at the Baseline (Day -1) visit using a scale from 1 to 7 defined as: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. | Baseline, Weeks 1 through 6 |
| ADHD RS-IV Preschool-Home Version Total score | The ADHD RS-IV Preschool Version is an 18-item scale corresponding to the 18 items in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision criteria that is divided into 2 subscales: hyperactivity/impulsivity and inattentiveness. Each item is scored on a 4-point scale ranging from 0 = never/rarely to 3 = very often. | Weeks 1 through 5 |
| ADHD RS-IV Preschool-Home Version hyperactivity and inattention subscales scores | The ADHD RS-IV Preschool Version is an 18-item scale corresponding to the 18 items in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision criteria that is divided into 2 subscales: hyperactivity/impulsivity and inattentiveness. Each item is scored on a 4-point scale ranging from 0 = never/rarely to 3 = very often. | Weeks 1 through 6 |
| ADHD RS-IV Preschool-School Version Total score | The ADHD RS-IV Preschool - School Version will be completed by the subject's teacher. | Weeks 3 and 6 |
| ADHD RS-IV Preschool-School Version hyperactivity and inattention subscales scores | The ADHD RS-IV Preschool - School Version will be completed by the subject's teacher. | Weeks 3 and 6 |
| To obtain contact information for a study center near you, click here. | View source |
| To obtain contact information for a study center near you, click here. | View source |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |