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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01014247




Registration number
NCT01014247
Ethics application status
Date submitted
12/11/2009
Date registered
16/11/2009
Date last updated
3/06/2013

Titles & IDs
Public title
Influence of Moxifloxacin on QTc Interval in Healthy Subjects for Positive Control Validation
Scientific title
A Randomized, Double-blind, 2-way Crossover, Placebo-controlled Study to Investigate the Influence of a Single-dose of Moxifloxacin on the QTc Interval in Healthy Male and Female Subjects for Positive Control Validation in Selected Centers of the PATENT-1 Trial
Secondary ID [1] 0 0
2009-012363-34
Secondary ID [2] 0 0
13796
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
QTc Evaluation 0 0
Electrocardiography 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Avelox (Moxifloxacin, BAY12-8039)
Treatment: Drugs - Placebo

Active Comparator: Arm 1 -

Placebo Comparator: Arm 2 -


Treatment: Drugs: Avelox (Moxifloxacin, BAY12-8039)
Single dose of 400 mg

Treatment: Drugs: Placebo
Single dose of matching tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
QTc interval at 3 hours
Timepoint [1] 0 0
Day 1 of treatment period 1 and 2
Secondary outcome [1] 0 0
Safety variables
Timepoint [1] 0 0
Up to last visit of follow up
Secondary outcome [2] 0 0
Pharmacokinetic parameters
Timepoint [2] 0 0
On different time points

Eligibility
Key inclusion criteria
- Healthy volunteers

- Age 18-75 years - Normal ECG
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Abnormal ECG - Intolerance to fluorochinolones

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2010
Sample size
Target
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Hessen
Country [2] 0 0
Germany
State/province [2] 0 0
Sachsen
Country [3] 0 0
Singapore
State/province [3] 0 0
Singapore
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01014247
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01014247