Guanfacine Immediate-release Electrocardiogram Results (QTc) Study
NCT ID: NCT00672984
Last Updated: 2021-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
83 participants
INTERVENTIONAL
2008-04-18
2008-08-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Immediate-release Guanfacine HCl
immediate release guanfacine hydrochloride
Subjects will receive 2x2mg immediate-release guanfacine on day 1. Subjects will receive 4x2mg immediate-release guanfacine on day 6.
Moxifloxacin HCl
moxifloxacin
Subjects will receive 400mg of moxifloxacin on day 1. Subjects will receive 400mg of moxifloxacin on day 6.
Placebo
Placebo
Subjects will receive placebo on Day 1. Subjects will receive placebo on Day 6.
Interventions
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immediate release guanfacine hydrochloride
Subjects will receive 2x2mg immediate-release guanfacine on day 1. Subjects will receive 4x2mg immediate-release guanfacine on day 6.
moxifloxacin
Subjects will receive 400mg of moxifloxacin on day 1. Subjects will receive 400mg of moxifloxacin on day 6.
Placebo
Subjects will receive placebo on Day 1. Subjects will receive placebo on Day 6.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
18 Years
45 Years
ALL
Yes
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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Charles River Clinical Services Northwest, Inc.
Tacoma, Washington, United States
Countries
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References
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Martin P, Satin L, Kahn RS, Robinson A, Corcoran M, Purkayastha J, Youcha S, Ermer JC. A thorough QT study of guanfacine. Int J Clin Pharmacol Ther. 2015 Apr;53(4):301-16. doi: 10.5414/CP202065.
Related Links
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FDA recall information
FDA-approved label
Other Identifiers
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SPD503-112
Identifier Type: -
Identifier Source: org_study_id
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