A Study of Pediatric Patients With Attention Deficit/Hyperactivity Disorder - NCT00965419-60048 (Clinical Trial 330552)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy330552.aspx
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| City: |
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Libertyville |
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State:
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IL |
| Zip Code: |
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60048 |
| Conditions: |
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Attention Deficit Hyperactivity Disorder |
| Purpose: |
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The primary purpose of your child's participation in the study is to determine whether
LY2216684 can help pediatric patients with ADHD, and assess the safety of LY2216684 and any
side effects that might be associated with it.
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| Study summary: |
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12 week dose titration and response assessment period. One (1) year open label treatment for
responders. Long-term extension of up to 4 additional years for responders. |
| Criteria: |
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INCLUSION CRITERIA:
- Patients must meet Diagnostic & Statistical Manual of Mental Disorders 4th Ed
diagnostic criteria for ADHD based Kiddie Schedule for Affective Disorders &
Schizophrenia for School Aged Children - Present and Lifetime Version at screening
for new patients/rollover patients.
- Patients must have an ADHDRS-IV-Parent: Inv total score of at least 1.5 standard
deviations above the age/gender norm at both screening/randomization. New patients
must have a CGI-ADHD-S score greater than or equal to 4 at both
screening/randomization.
- Patients of child-bearing potential agree to use a reliable method of birth control
during the study and for 1 month following the last dose of study drug. Female
patients of child-bearing potential must test negative for pregnancy at the time of
enrollment based on a urine pregnancy test.
- Patients must have laboratory results, showing no clinically significant
abnormalities.
- Parents/patients must have a degree of understanding sufficient to communicate
suitably with the investigator/ study coordinator.
- Patients must be of normal intelligence.
- Patients/parents must have been judged by the investigator to be reliable to keep
appointments for clinic visits/all tests, including venipunctures and examinations
required by the protocol.
- Patients must be able to swallow tablets.
EXCLUSION CRITERIA:
- Patients who weigh less than 16 kg at screening/randomization.
- Female patients who are pregnant/breastfeeding.
- Patients who have previously withdrawn/discontinued early from this study or any
other study investigating LY2216684.
- Patients who have a history of Bipolar I/II disorder, psychosis, or pervasive
developmental disorder.
- Patients with a history of any seizure disorder or known electroencephalographic
(EEG) abnormalities in the absence of seizures.
- Patients who are at serious suicidal risk.
- Patients with a history of severe allergies to more than 1 class of medications, or
multiple adverse drug reactions, or known hypersensitivity to LY2216684.
- Patients with a history of alcohol or drug abuse/dependence within the past 3 months
of screening, or who are currently using alcohol, drugs of abuse, or any prescribed
or over-the-counter medication in a manner that the investigator considers indicative
of abuse/dependence.
- Patients who screen positive for drugs of abuse cannot participate.
- Patients who have a medical condition that would increase sympathetic nervous system
activity markedly, or who are taking a medication on a daily basis that has
sympathomimetic activity are excluded.
- Patients with problems that would be exacerbated by increased norepinephrine tone
including a history of cardiovascular disease, thyroid dysfunction, glaucoma, or
urinary retention.
- Patients who at any time during the study are likely to need psychotropic medications
apart from the drugs under study.
- Patients who have used a monoamine oxidase inhibitor (MAOI) during the 2 weeks prior
to randomization.
- Patients with current or past history of clinically significant hypertension.
- Patients who are currently enrolled in, or discontinued within the last 30 days from
a clinical trial involving an off-label use of an investigational drug, or
concurrently enrolled in any other type of medical research judged not to be
scientifically or medically compatible with this study.
- Patients whose family anticipates a move outside the geographic range of the
investigative site during participation in the study or who plan extended travel
inconsistent with the recommended visit intervals.
- Patients who, in the opinion of the investigator, are unsuitable in any other way to
participate in this study. |
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| Study is available at: |
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Libertyville, IL 60048
United States
Primary Contact:
There may be multiple sites in this clinical trial. 1-877-CTLilly (1-877-285-4559) or
Phone: 1-317-615-4559 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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