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NCT00302406 · ClinicalTrials.gov registry record · Phase 4
Naturalistic Substitution of Concerta in Adult Subject With ADHD Receiving Immediate Release Methylphenidate
A Phase 4 study of Attention Deficit Hyperactivity Disorder, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT00302406 is a Phase 4 study of Attention Deficit Hyperactivity Disorder that has completed, run by Massachusetts General Hospital. The registered enrollment target is 50 participants, below the 206-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00302406, a Phase 4 study of Attention Deficit Hyperactivity Disorder, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-blind study looking at the efficacy and satisfaction of Concerta substitution in adult subjects with ADHD receiving immediate release methylphenidate. Subjects will be administered a maximum dose of 1.3mg/kg/day of either methylphenidate or Concerta. The specific hypotheses of this study are: Hypothesis 1: ADHD symptomatology in adults with DSM-IV, ADHD will continue to be controlled in patients switched from MPH IR TID to Concerta. Hypothesis 2: Patient satisfaction will not decrease in patients switched from MPH IR TID to Concerta (ie., all patients will be equally or more satisfied on Concerta as compared with MPH IR TID.
Conditions Studied
Interventions
- DRUG methylphenidate hydrochloride
- DRUG OROS methylphenidate hydrochloride (CONCERTA)
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Cambridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2003-07 |
| Est. Completion | 2007-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00302406
The ClinicalTrials.gov registry entry for NCT00302406 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 206-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (76% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 2 interventions - of which methylphenidate hydrochloride is the first listed.
NCT00302406 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00302406 about?
NCT00302406 is a clinical study titled "Naturalistic Substitution of Concerta in Adult Subject With ADHD Receiving Immediate Release Methylphenidate". This is a single-blind study looking at the efficacy and satisfaction of Concerta substitution in adult subjects with ADHD receiving immediate release methylphenidate. Subjects will be administered a maximum dose of 1.3mg/kg/day of either methylphenidate or Concerta. The specific hypotheses of this ...
What is the current status of trial NCT00302406?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2003-07. Estimated completion is 2007-11.
What conditions does trial NCT00302406 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder.
What interventions are being tested in trial NCT00302406?
The interventions under investigation include: methylphenidate hydrochloride (DRUG), OROS methylphenidate hydrochloride (CONCERTA) (DRUG).
Who is sponsoring clinical trial NCT00302406?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00302406 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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