Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia
NCT ID: NCT01457339
Last Updated: 2021-06-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
31 participants
INTERVENTIONAL
2011-10-21
2012-01-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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SPD489 (Lisdexamfetamine dimesylate)
SPD489 (Lisdexamfetamine dimesylate)
SPD489 administered orally in ascending doses (50mg, 70mg, 100mg, 150mg, 200mg, 250mg). Each of these doses will be administered once daily for 5 days. Total number of days dosed is 30 days.
Placebo
Placebo
Placebo Capsule(s) for oral use taken once daily for 30 days
Interventions
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SPD489 (Lisdexamfetamine dimesylate)
SPD489 administered orally in ascending doses (50mg, 70mg, 100mg, 150mg, 200mg, 250mg). Each of these doses will be administered once daily for 5 days. Total number of days dosed is 30 days.
Placebo
Placebo Capsule(s) for oral use taken once daily for 30 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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California Clinical Trials
Glendale, California, United States
Collaborative Neuroscience Network, Inc
Long Beach, California, United States
Countries
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Other Identifiers
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SPD489-119
Identifier Type: -
Identifier Source: org_study_id
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