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

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Bayer

Status and phase

Completed
Phase 1

Conditions

QTc Evaluation
Electrocardiography

Treatments

Drug: Avelox (Moxifloxacin, BAY12-8039)
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01014247
2009-012363-34 (EudraCT Number)
13796

Details and patient eligibility

About

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).

Enrollment

56 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Healthy volunteers
  • Age 18-75 years - Normal ECG Exclusion Criteria:
  • Abnormal ECG - Intolerance to fluorochinolones

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

56 participants in 2 patient groups, including a placebo group

Arm 1
Active Comparator group
Treatment:
Drug: Avelox (Moxifloxacin, BAY12-8039)
Arm 2
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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