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
Abstract
To assess the effect of immediate-release guanfacine hydrochloride, administered at therapeutic and supratherapeutic doses, on QT/QTc in healthy normal males and females
Conditions: Healthy Volunteers.
Primary outcome: Change From Baseline in Electrocardiogram Results (QTcNi) at Time of Maximum Plasma Concentration (Tmax) on Day 1; Change From Baseline in Electrocardiogram Results (QTcNi) at Tmax on Day 6; Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 1; Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 6; Change From Baseline in Heart Rate (HR) at Tmax on Day 1; Change From Baseline in Heart Rate (HR) at Tmax on Day 6; Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 1; Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 6.
Enrollment: 83 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 83 participants or records.
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