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

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

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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