CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 83 enrolled
Drug / intervention
immediate release guanfacine hydrochloride +2 moredrug
Likely dose
moxifloxacin 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00672984
NCT00672984Phase 1Completed
CompareCT.gov

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

Shire·interventional·Posted May 6, 2008·Updated Jun 14, 2021

In Brief

A Phase 1 clinical trial evaluating immediate release guanfacine hydrochloride, moxifloxacin, and 1 other intervention for Healthy Volunteers. Completed, enrolled 83 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 6, 2008
Enrollment StartApr 18, 2008
Primary CompletionAug 7, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 18.2 years ago

Interventions

immediate release guanfacine hydrochloridedrug

Subjects will receive 2x2mg immediate-release guanfacine on day 1. Subjects will receive 4x2mg immediate-release guanfacine on day 6.

moxifloxacindrug

Subjects will receive 400mg of moxifloxacin on day 1. Subjects will receive 400mg of moxifloxacin on day 6.

Placebodrug

Subjects will receive placebo on Day 1. Subjects will receive placebo on Day 6.