Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study was cancelled prior to the enrollment of any participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
2-week open-label safety, tolerability and pharmacokinetic study of methylphenidate HCl ERCT in 4-5 year old children with ADHD.
Phase 4, Open-label, Safety, Tolerability And Pharmacokinetic Study Of methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablets (ERCT) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (ADHD)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| methylphenidate HCl ERCT | Other | methylphenidate HCl ERCT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylphenidate HCl ERCT | Drug | methylphenidate HCl ERCT |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter-Tmax | PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT. | 2 weeks |
| PK parameter- Cmax | PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT. | 2 weeks |
| PK parameter- AUClast | PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT. | 2 weeks |
| PK parameter-AUC0-2 | PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT. | 2 weeks |
| PK parameter-AUC2-6 | PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT. | 2 weeks |
| PK parameter-AUC6-24 | PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT. | 2 weeks |
| PK parameter-AUCinf | PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT. | 2 weeks |
| PK parameter- t1/2 | PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT. |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of treatment emergent adverse events (safety and tolerability) | incidence of treatment emergent adverse events (safety and tolerability) | 2 weeks |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
Not provided
Not provided
| 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 |
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 2 weeks |
| PK parameter-CL/F | PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT. | 2 weeks |
| PK parameter-Vz/F | PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT. | 2 weeks |
| 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 |
| 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 |
| To obtain contact information for a study center near you, click here. | View source |