Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke

NCT ID: NCT00240643

Last Updated: 2017-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

640 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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A randomized, double blind, double dummy, parallel group, placebo controlled study to evaluate the pharmacodynamic and pharmacokinetic response and safety and tolerability of SB424323 (250 mg, 375 mg and 500 mg) administered twice daily for 16 weeks, on top of aspirin (325 mg, qd) in men and women with non valvular atrial fibrillation at a low or intermediate risk for stroke

Conditions

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Fibrillation, Atrial Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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SB424323

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK Clinical Disclosure

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Mobile, Alabama, United States

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Troy, Michigan, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Camp Hill, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Houston, Texas, United States

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Walla Walla, Washington, United States

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Milwaukee, Wisconsin, United States

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Buenos Aires, Buenos Aires, Argentina

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Capital Federal, Buenos Aires, Argentina

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Capital Fefderal, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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Córdoba, Córdoba Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Moron-Provincia de Buenos Aires, , Argentina

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Antwerp, , Belgium

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Linkebeek, , Belgium

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, São Paulo, Brazil

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Halifax, Nova Scotia, Canada

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Truro, Nova Scotia, Canada

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Burlington, Ontario, Canada

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Grimsby, Ontario, Canada

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Hamilton, Ontario, Canada

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Newmarket, Ontario, Canada

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Toronto, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Longueuil, Quebec, Canada

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Montreal, Quebec, Canada

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Saint-Lambert, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Aarhus, , Denmark

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Frederiksberg, , Denmark

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Tallinn, , Estonia

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Tartu, , Estonia

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Créteil, , France

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Mont-de-Marsan, , France

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Toulouse, , France

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Tours, , France

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Künzing, Bavaria, Germany

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Northeim, Lower Saxony, Germany

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Weyhe-Leeste, Lower Saxony, Germany

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Chemnitz, Saxony, Germany

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Ebersbach, Saxony, Germany

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Königsbrück, Saxony, Germany

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Leipzig, Saxony, Germany

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Leipzig, Saxony, Germany

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Leisnig, Saxony, Germany

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Markkleeberg, Saxony, Germany

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Wolmirstedt, Saxony-Anhalt, Germany

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Bad Segeberg, Schleswig-Holstein, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Jena, Thuringia, Germany

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Athens, , Greece

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Athens, , Greece

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Sopron, , Hungary

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Székesfehérvár, , Hungary

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Szolnok, , Hungary

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Szolnok, , Hungary

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Bangalore, , India

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Bangalore, , India

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Hyderabad, , India

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Mumbai, , India

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New Delhi, , India

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Catanzaro, Calabria, Italy

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Caserta, Campania, Italy

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Rome, Lazio, Italy

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Città Della Pieve (PG), Umbria, Italy

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Riga, , Latvia

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Riga, , Latvia

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México, , Mexico

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Delft, , Netherlands

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The Hague, , Netherlands

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Utrecht, , Netherlands

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Auckland, , New Zealand

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Christchurch, , New Zealand

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Hamilton, , New Zealand

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Takapuna, Auckland, , New Zealand

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Elverum, , Norway

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Oslo, , Norway

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Skien, , Norway

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Bucharest, , Romania

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Bucharest, , Romania

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Târgu Mureş, , Romania

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Kwangju, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Alicante, , Spain

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Alicante, , Spain

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Barcelona, , Spain

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Cadiz, , Spain

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Leganés, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Sant Joan d'Alacant, , Spain

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Gothenburg, , Sweden

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Stockholm, , Sweden

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Uppsala, , Sweden

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Taipei, , Taiwan

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Bangkok, , Thailand

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Chiang Mai, , Thailand

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Glasgow, Lanarkshire, United Kingdom

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Harrow, Middlesex, United Kingdom

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Northwood, Middlesex, United Kingdom

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Birmingham, West Midlands, United Kingdom

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Antrim, , United Kingdom

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Dundee, , United Kingdom

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Manchester, , United Kingdom

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York, , United Kingdom

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Countries

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United States Argentina Belgium Brazil Canada Denmark Estonia France Germany Greece Hungary India Italy Latvia Mexico Netherlands New Zealand Norway Romania South Korea Spain Sweden Taiwan Thailand United Kingdom

Other Identifiers

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101724

Identifier Type: -

Identifier Source: org_study_id

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