ADHD, ADDPhase 3NCT00301236
Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder
A Phase 3 study testing Dexmethylphenidate HCl extended-release capsules in people with ADHD, ADD, run by Novartis at 25 sites in United States.
Trial summary
The purpose of this study is to determine which dosages of dexmethylphenidate HCl extended-release capsules may represent effective treatment for ADHD in children 6-12 years of age. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- ADHD, ADD
- What is being tested?
- Dexmethylphenidate HCl extended-release capsules
- Type of treatment
- Pill or oral medicine
- How many people
- 252 participants
- Where
- 25 sitesUnited States
- Study dates
- Feb 2006to Nov 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Child
Who may be able to join
- Children 6 - 12 with a diagnosis of ADHD of any type , Same teacher who is willing to complete the assessment during the school term
Who cannot join
- Previous cardiac problems of the patient or the parents or current cardiac findings of the patient; Relevant medical condition other than ADHD; ADHD medication within a specified timeperiod prior to study start; Pregnancy or nursing; Positive drug screen
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Novartis Investigational Site
Boulder, Colorado, 80304
Novartis Investigational Site
Cambridge, Massachusetts, 02138
Novartis Investigational Site
Chapel Hill, North Carolina, 27514
Novartis Investigational Site
Columbus, Ohio, 43205
Novartis Investigational Site
Gresham, Oregon, 97030
Novartis Investigational Site
Houston, Texas, 77007
Novartis Investigational Site
Jackson, Tennessee, 38305
Novartis Investigational Site
Las Vegas, Nevada, 89128
Novartis Investigational Site
Libertyville, Illinois, 60048
Novartis Investigational Site
Little Rock, Arkansas, 72205
Novartis Investigational Site
Los Angeles, California, 90095
Novartis Investigational Site
Maitland, Florida, 32751
Novartis Investigational Site
Memphis, Tennessee, 38119
Novartis Investigational Site
Mesa, Arizona, 85210
Novartis Investigational Site
New York, New York, 10029
Novartis Investigational Site
New York, New York, 10032
Novartis Investigational Site
Orlando, Florida, 32806
Novartis Investigational Site
Overland Park, Kansas, 66211
Novartis Investigational Site
Philadelphia, Pennsylvania, 19149
Novartis Investigational Site
Piscataway, New Jersey, 08855
Novartis Investigational Site
Prairie Village, Kansas, 66206
Novartis Investigational Site
Raleigh, North Carolina, 27609
Novartis Investigational Site
Staten Island, New York, 10305
Novartis Investigational Site
Stone Mountain, Georgia, 30083
Novartis Investigational Site
Toms River, New Jersey, 08755
About this study
Official title: A 5-Week Treatment, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Fixed-Dose Study of the Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules Administered Once Daily in Pediatric Children With Attention-Deficit/Hyperactivity Disorder
The purpose of this study is to determine which dosages of dexmethylphenidate HCl extended-release capsules may represent effective treatment for ADHD in children 6-12 years of age.
Read the detailed description
The purpose of this study is to determine which dosages of dexmethylphenidate HCl extended-release capsules may represent effective treatment for ADHD in children 6-12 years of age.
- Conditions
- ADHD, ADD
- Being tested
- Dexmethylphenidate HCl extended-release capsules
- Keywords
- ADHD, children, CADS-T, Dexmethylphenidate-HCl, extended release
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmethylphenidate HCl extended-release capsulesDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the symptoms by the patient's teacher after 5 weeks of treatment.
Secondary outcomes (4)
Assessment of the symptoms by the patient's parent after five weeks of treatment.
Change in severity of the illness assessed by the physician after 5 weeks of treatment
Improvement of the illness assessed by the physician after 5 weeks of treatment
Safety and tolerability of 5 week's treatment with dexmethylphenidate HCl extended-release capsules in children with Attention-Deficit/Hyperactivity Disorder by assessing the frequency of adverse findings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2006 (estimated)
- Study startFeb 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHD, ADDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 252 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301236
- Sponsor's protocol ID
- CRIT124E2305
- Status last verified
- Dec 2007
- First submitted
- 8 Mar 2006
- Last updated
- 21 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 5-Week Treatment, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Fixed-Dose Study of the Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules Administered Once Daily in Pediatric Children With Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT00301236
- Acronym / sponsor ID
- CRIT124E2305
- Conditions
- ADHD, ADD
- Keywords
- ADHD, children, CADS-T, Dexmethylphenidate-HCl, extended release
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Study completion
- Nov 2006 (actual)
- First posted
- 10 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine which dosages of dexmethylphenidate HCl extended-release capsules may represent effective treatment for ADHD in children 6-12 years of age.
Detailed description
The purpose of this study is to determine which dosages of dexmethylphenidate HCl extended-release capsules may represent effective treatment for ADHD in children 6-12 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 6 - 12 with a diagnosis of ADHD of any type , Same teacher who is willing to complete the assessment during the school term
Key exclusion criteria (2 listed)
- Previous cardiac problems of the patient or the parents or current cardiac findings of the patient; Relevant medical condition other than ADHD; ADHD medication within a specified timeperiod prior to study start; Pregnancy or nursing; Positive drug screen
- Other protocol-defined inclusion/exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmethylphenidate HCl extended-release capsules | Drug | – |
Primary outcome
Assessment of the symptoms by the patient's teacher after 5 weeks of treatment.
4 secondary outcomes
Assessment of the symptoms by the patient's parent after five weeks of treatment.
Change in severity of the illness assessed by the physician after 5 weeks of treatment
Improvement of the illness assessed by the physician after 5 weeks of treatment
Safety and tolerability of 5 week's treatment with dexmethylphenidate HCl extended-release capsules in children with Attention-Deficit/Hyperactivity Disorder by assessing the frequency of adverse findings
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study chair
Novartis Pharmaceuticals
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmethylphenidate HCl extended-release capsules in people with ADHD, ADD, run by Novartis at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the symptoms by the patient's teacher after 5 weeks of treatment.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2007.