Influence of Moxifloxacin on QTc Interval in Healthy Subjects for Positive Control Validation

NCT ID: NCT01014247

Last Updated: 2013-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-06-30

Brief Summary

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The aim of this study is to investigate the effect of moxifloxacin on the QT interval in order to gain information on the validity of results that will be collected during another clinical study testing riociguat in patients with pulmonary arterial hypertension (PATENT-1 study).

Detailed Description

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Conditions

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QTc Evaluation Electrocardiography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type ACTIVE_COMPARATOR

Avelox (Moxifloxacin, BAY12-8039)

Intervention Type DRUG

Single dose of 400 mg

Arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single dose of matching tablet

Interventions

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Avelox (Moxifloxacin, BAY12-8039)

Single dose of 400 mg

Intervention Type DRUG

Placebo

Single dose of matching tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers

Exclusion Criteria

* Abnormal ECG - Intolerance to fluorochinolones
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer HealthCare Pharmaceuticals Inc.

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Melbourne, Victoria, Australia

Site Status

Giessen, Hesse, Germany

Site Status

Dresden, Saxony, Germany

Site Status

Singapore, , Singapore

Site Status

Singapore, , Singapore

Site Status

London, , United Kingdom

Site Status

Countries

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Australia Germany Singapore United Kingdom

Other Identifiers

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2009-012363-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

13796

Identifier Type: -

Identifier Source: org_study_id

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