The Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder
NCT ID: NCT03324581
Last Updated: 2021-10-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
239 participants
INTERVENTIONAL
2017-11-09
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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OPC-64005
During the titration period, participants received OPC-64005 two 10 milligram (mg) tablets, and one OPC-64005-matching placebo tablet along with two atomoxetine-matching placebo capsules, orally, once daily (QD), from Day 1 up to Day 4. During the treatment period, participants received OPC-64005 three 10 mg tablets, and two atomoxetine-matching placebo capsules, orally, QD, from Day 5 up to Day 56. The dose was reduced to 20 mg if the 30 mg dose in the treatment period was not tolerable.
OPC-64005
OPC-64005 film coated tablets
Placebo
OPC-64005-matching placebo film coated tablets and atomoxetine-matching placebo gelatin capsules
Atomoxetine
During the titration period, participants received atomoxetine one 40 mg capsule and one atomoxetine-matching placebo capsule along with three OPC-64005-matching placebo tablets, orally, QD, from Day 1 up to Day 4.
During the treatment period, participants received two atomoxetine 40 mg capsules and three OPC-64005-matching placebo tablets, orally, QD, from Day 5 up to Day 56. The dose was reduced to 40 mg if the 80 mg dose in the treatment period was not tolerable.
Atomoxetine
Atomoxetine gelatin capsules
Placebo
OPC-64005-matching placebo film coated tablets and atomoxetine-matching placebo gelatin capsules
Placebo
Participants received three OPC-64005-matching placebo tablets and two atomoxetine-matching placebo capsules, orally, QD, from Day 1 up to Day 56.
Placebo
OPC-64005-matching placebo film coated tablets and atomoxetine-matching placebo gelatin capsules
Interventions
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OPC-64005
OPC-64005 film coated tablets
Atomoxetine
Atomoxetine gelatin capsules
Placebo
OPC-64005-matching placebo film coated tablets and atomoxetine-matching placebo gelatin capsules
Eligibility Criteria
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Inclusion Criteria
* Participants with a primary Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis of ADHD (including predominantly inattentive presentation, hyperactive presentation, and combined presentations) as confirmed by the Adult ADHD Clinical Diagnostic Scale (ACDS) v 1.2.
* Participants willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and up to the 30 (+ 2)-day follow-up period.
Exclusion Criteria
* Participants who report allergies (lifetime treatment history) to stimulant or nonstimulant ADHD medications.
* Participants with other DSM-5 disorders including psychosis (current or lifetime), bipolar disorder (current or lifetime), current major depressive disorder, or current panic disorder; or another psychiatric diagnosis that the investigator believes is primary or that will confound efficacy or safety assessments of the trail or interfere with participation in the trial otherwise.
* Participants with a clinically significant current DSM-5 diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, histrionic, narcissistic, avoidant, obsessive compulsive, or dependent personality disorders.
* Participants who currently have clinically significant dermatological, neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders such as any history of myocardial infarction, congestive heart failure, HIV (human immunodeficiency virus) seropositive status/acquired immunodeficiency syndrome, or active or chronic hepatitis B or C.
* Participants with a history of obstructive sleep apnea.
18 Years
55 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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Southern California Research, LLC
Beverly Hills, California, United States
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Artemis Institute for Clinical Research
San Marcos, California, United States
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, United States
Meridien Research
Bradenton, Florida, United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, United States
Behavioral Clinical Research, Inc.
North Miami, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Clinical Neuroscience Solutions Inc.
Orlando, Florida, United States
iResearch Atlanta
Decatur, Georgia, United States
Northwest Behavioral Research Center
Marietta, Georgia, United States
Psychiatric Associates
Overland Park, Kansas, United States
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, United States
Center for Psychiatry and Behavioral Medicine Inc.
Las Vegas, Nevada, United States
Eastside Comprehensive Medical Center, LLC.
New York, New York, United States
The Medical Research Network, LLC
New York, New York, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Paradigm Research Professionals
Oklahoma City, Oklahoma, United States
Oregon Center for Clinical Investigators, Inc.
Portland, Oregon, United States
Oregon Center for Clinical Investigators, Inc.
Salem, Oregon, United States
BTC of Lincoln
Lincoln, Rhode Island, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Aspen Clinical Research
Orem, Utah, United States
Neuropsychiatric Associates
Woodstock, Vermont, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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277-201-00001
Identifier Type: -
Identifier Source: org_study_id