Guanfacine Immediate-Release Thorough QTc Study - Tabular View

Tracking Information

First Received Date ^ICMJE

May 2, 2008

Last Updated Date

March 24, 2009

Start Date ^ICMJE

April 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Qt/QTc difference from time matched baseline [ Time Frame: During any of 3 arms (Moxifloxacin, Placebo, or Immediate-Release Guanfacine) EKGs will be acquired during Day -1, for baseline, and Day 1 and Day 6 of treatment ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00672984 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Measure will be same via QT/QTc difference from baseline, but will be based on Holter (bin) data analysis method [ Time Frame: During any of 3 arms (Moxifloxacin, Placebo, or Immediate-Release Guanfacine) EKGs will be acquired during Day -1, for baseline, and Day 1 and Day 6 of treatment Times: 30 min pre-dose, 1, 2, 3, 4, 5, 6, 8, 12 and 24h post-dose ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Guanfacine Immediate-Release Thorough QTc Study

Official Title ^ICMJE

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

Brief 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

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: immediate release guanfacine hydrochloride
Drug: moxifloxacin
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy Normal Subjects

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00672984

Responsible Party

Gerald Tremblay, M.D., Shire Pharmaceutical

Study ID Numbers ^ICMJE

SPD503-112

Study Sponsor ^ICMJE

Shire Pharmaceutical Development

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Robert S. Kahn, MD

Charles River Clinical Services Northwest Inc.

Information Provided By

Shire Pharmaceutical Development

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP