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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00240643




Registration number
NCT00240643
Ethics application status
Date submitted
14/10/2005
Date registered
18/10/2005
Date last updated
16/01/2017

Titles & IDs
Public title
Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke
Scientific title
A Randomized, Double Blind, Double Dummy, Parallel Group, Placebo Controlled Study to Evaluate the Pharmacodynamic and Pharmacokinetic Response and Safety and Tolerability of SB424323 (250mg, 375mg and 500 mg) Administered Twice Daily for 16 Weeks, on Top of Asprin (325mg, qd) in Men and Women With Non Valvular Atrial Fibrillation at a Low or Intermediate Risk for Stroke
Secondary ID [1] 0 0
101724
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibrillation, Atrial 0 0
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Relationship between anti IIa (a biomarker)and the dose of SB424323.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Blood levels of SB424323 during the study. Number of strokes, transient ischemic attacks or systemic embolism during the study. Changes in laboratory tests during the study.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Patients with non valvular atrial fibrillation and any of the following:
* </= 60 years old with no heart disease.
* 60 years old with heart disease but no risk factors.
* >/=60 years old and </=75 years old with no risk factors and no heart disease.
* Must be able to take aspirin.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous heart attack or stroke.
* History of high blood pressure, diabetes or a prior blood clot.
* Liver or kidney disease.
* Need for anti-thrombotic or anti-platelet drugs.
* Need for cardiovascular medicines.

Study design
Purpose of the study
Prevention
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?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2006
Sample size
Target
Accrual to date
Final
640
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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Michigan
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United States of America
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Ohio
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United States of America
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Pennsylvania
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Texas
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Córdova
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Argentina
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Santa Fe
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Argentina
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Ciudad Autónoma de Buenos Aires
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Argentina
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Moron-Provincia de Buenos Aires
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Belgium
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Antwerpen
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Belgium
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Linkebeek
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Brazil
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Rio Grande Do Sul
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Brazil
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São Paulo
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Nova Scotia
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Tallinn
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Tours
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Bayern
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Germany
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Niedersachsen
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Germany
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Sachsen-Anhalt
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Germany
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Sachsen
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Germany
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Schleswig-Holstein
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Germany
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Thueringen
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Germany
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Berlin
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Sopron
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Szolnok
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Kwangju
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Auckland
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Christchurch
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Hamilton
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Takapuna, Auckland
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Elverum
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Oslo
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Skien
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Bucharest
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Bucuresti
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Targu-Mures
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Alicante
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Barcelona
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Cadiz
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Leganes
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Madrid
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Spain
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San Juan De Alicante
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Sweden
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Göteborg
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Stockholm
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Sweden
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Uppsala
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Taiwan
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Taipei
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Bangkok
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Chiangmai
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United Kingdom
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Lanarkshire
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Middlesex
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West Midlands
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Antrim
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Dundee
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Manchester
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York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will allow determination of the pharmacokinetic and pharmacodynamics of SB424323 in a relevant population. The data from this study will be used along with other data to aid in choosing the most appropriate dose for the later phase study.
Trial website
https://clinicaltrials.gov/study/NCT00240643
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
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/study/NCT00240643