Guanfacine Immediate-release Electrocardiogram Results (QTc) Study

NCT ID: NCT00672984

Last Updated: 2021-06-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-18

Study Completion Date

2008-08-07

Brief Summary

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To assess the effect of immediate-release guanfacine hydrochloride, administered at therapeutic and supratherapeutic doses, on QT/QTc in healthy normal males and females

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Immediate-release Guanfacine HCl

Group Type EXPERIMENTAL

immediate release guanfacine hydrochloride

Intervention Type DRUG

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

Moxifloxacin HCl

Group Type ACTIVE_COMPARATOR

moxifloxacin

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Intervention Type DRUG

moxifloxacin

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Tenex Avelox

Eligibility Criteria

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Inclusion Criteria

* Healthy Normal Subjects
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shire

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 25109412 (View on PubMed)

Related Links

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Other Identifiers

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SPD503-112

Identifier Type: -

Identifier Source: org_study_id

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