check_circleStudy Completed
QTc evaluation, Electrocardiography
Bayer Identifier:
13796
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Influence of moxifloxacin on QTc interval in healthy subjects for positive control validation
Trial purpose
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).
Key Participants Requirements
Sex
BothAge
18 - 75 YearsTrial summary
Enrollment Goal
56Trial Dates
November 2009 - June 2010Phase
Phase 1Could I Receive a placebo
YesProducts
Avelox (Moxifloxacin hydrochloride, BAY12-8039)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Medizinische Fakultät Carl Gustav Carus | Dresden, 01307, Germany |
Completed | Universitätsklinikum Giessen und Marburg | Gießen, 35392, Germany |
Completed | Nucleus Network Ltd | Melbourne, 3004, Australia |
Completed | National University Hospital | Singapore, 119228, Singapore |
Completed | National Heart Centre | Singapore, 168752, Singapore |
Terminated | Hammersmith Hospital | London, W12 0HS, United Kingdom |
Primary Outcome
- QTc interval at 3 hoursdate_rangeTime Frame:Day 1 of treatment period 1 and 2enhanced_encryptionyesSafety Issue:
Secondary Outcome
- Safety variablesAdverse events, clinical laboratory, vital signs, ECG findingsdate_rangeTime Frame:Up to last visit of follow upenhanced_encryptionYesSafety Issue:
- Pharmacokinetic parametersCmax, Cmax,norm, tmaxdate_rangeTime Frame:On different time pointsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Crossover AssignmentTrial Arms
2