Guanfacine Immediate-Release Thorough QTc Study
Information source: Shire Pharmaceutical Development
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: immediate release guanfacine hydrochloride (Drug); moxifloxacin (Drug); Placebo (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Shire Pharmaceutical Development Official(s) and/or principal investigator(s):
Robert S. Kahn, MD, Principal Investigator, Affiliation: Charles River Clinical Services Northwest Inc.
Overall contact:
Shire Call Center, Phone: +1 866-842-5335
Summary
To assess the effect of immediate-release guanfacine hydrochloride, administered at
therapeutic and supratherapeutic doses, on QT/QTc in healthy normal males and females
Clinical Details
Official title: A Phase I, Randomized, Gender Stratified, Double-Blind, Placebo- and Positive-Controlled, Three Period Crossover Trial to Assess the Effect of Guanfacine Hydrochloride on QT/QTc Interval in Healthy Men and Women
Study design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Primary outcome: Qt/QTc difference from time matched baseline
Secondary outcome: Measure will be same via QT/QTc difference from baseline, but will be based on Holter (bin) data analysis method
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy Normal Subjects
Locations and Contacts
Shire Call Center, Phone: +1 866-842-5335
Charles River Clinical Services Northwest, Inc., Tacoma, Washington, United States; Recruiting
Additional Information
Starting date: April 2008
Ending date: August 2008
Last updated: May 5, 2008
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