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Concerta (Methylphenidate) -To-Generic Switch Study

NCT02730572 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1464

Last updated 2017-02-13

No results posted yet for this study

Summary

The primary purpose of this study is to identify whether, after adjustment for confounders via stratification on a propensity score and adjustment for calendar year, the combined endpoint consisting of #1 to #4 (1. switching back to Concerta, 2. changing the use of immediate release \[IR\] methylphenidate, 3. beginning a new attention deficit hyperactivity disorder \[ADHD\] medication, or 4. stopping both Concerta and the long acting \[LA\] methylphenidate {authorized generic \[AG\] methylphenidate or equivalent generic \[EG\] methylphenidate} that was begun on the index date), differs between participants who switch from branded Concerta to the EG formulations versus participants who switch from branded Concerta to the AG formulation.

Conditions

  • Attention Deficit Disorder With Hyperactivity

Interventions

DRUG

Concerta

This is an observational study. Participants who have been on Concerta for at least 60 days will be observed.

DRUG

Concerta AG formulation

This is an observational study. Participants who have been on Concerta for at least 60 days and switch to authorized generic will be observed.

DRUG

Concerta EG formulation

This is an observational study. Participants who have been on Concerta for at least 60 days and switch to equivalent generic will be observed.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Eligibility

Min Age
6 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-10-31
Completion
2016-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02730572 on ClinicalTrials.gov