NCT01014247

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_1

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 16, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 3, 2013

Status Verified

May 1, 2013

Enrollment Period

7 months

First QC Date

November 12, 2009

Last Update Submit

May 31, 2013

Conditions

QTc EvaluationElectrocardiography

Keywords

Moxifloxacin

Outcome Measures

Primary Outcomes (1)

  • QTc interval at 3 hours

    Day 1 of treatment period 1 and 2

Secondary Outcomes (2)

  • Safety variables

    Up to last visit of follow up

  • Pharmacokinetic parameters

    On different time points

Study Arms (2)

Arm 1

ACTIVE COMPARATOR
Drug: Avelox (Moxifloxacin, BAY12-8039)

Arm 2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Avelox (Moxifloxacin, BAY12-8039)DRUG

Single dose of 400 mg

Arm 1
PlaceboDRUG

Single dose of matching tablet

Arm 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers

You may not qualify if:

  • Abnormal ECG - Intolerance to fluorochinolones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Melbourne, Victoria, 3004, Australia

Location

Unknown Facility

Giessen, Hesse, 35392, Germany

Location

Unknown Facility

Dresden, Saxony, 01307, Germany

Location

Unknown Facility

Singapore, 119228, Singapore

Location

Unknown Facility

Singapore, 168752, Singapore

Location

Unknown Facility

London, W12 0HS, United Kingdom

Location

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 12, 2009

First Posted

November 16, 2009

Study Start

November 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

June 3, 2013

Record last verified: 2013-05

Locations

AU(1)DE(2)SG(2)GB(1)