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

January 13, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

640

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1428
        • GSK Investigational Site
      • Buenos Aires, Argentina, 1704
        • GSK Investigational Site
      • Ciudad Autónoma de Buenos Aires, Argentina, 1221
        • GSK Investigational Site
      • Ciudad Autónoma de Buenos Aires, Argentina, 1405
        • GSK Investigational Site
      • Moron-Provincia de Buenos Aires, Argentina, 1709
        • GSK Investigational Site
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1180AAX
        • GSK Investigational Site
      • Capital Fefderal, Buenos Aires, Argentina
        • GSK Investigational Site
    • Córdova
      • Cordoba, Córdova, Argentina, 5003
        • GSK Investigational Site
      • Córdoba, Córdova, Argentina, 5000
        • GSK Investigational Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • GSK Investigational Site
  • Belgium
      • Antwerpen, Belgium, 2020
        • GSK Investigational Site
      • Linkebeek, Belgium, 1630
        • GSK Investigational Site
  • Brazil
      • São Paulo, Brazil, 04024-002
        • GSK Investigational Site
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 40110-160
        • GSK Investigational Site
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 5R3
        • GSK Investigational Site
      • Truro, Nova Scotia, Canada, B2N 1L2
        • GSK Investigational Site
    • Ontario
      • Burlington, Ontario, Canada, L7M 4Y1
        • GSK Investigational Site
      • Grimsby, Ontario, Canada, L3M 1P3
        • GSK Investigational Site
      • Hamilton, Ontario, Canada, L8P 3B6
        • GSK Investigational Site
      • Newmarket, Ontario, Canada, L3Y 8C3
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M3J 1N2
        • GSK Investigational Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2G8
        • GSK Investigational Site
      • Longueuil, Quebec, Canada, J4K 1E3
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H2L 4M1
        • GSK Investigational Site
      • St-Lambert, Quebec, Canada, J4P 2H4
        • GSK Investigational Site
      • Trois Rivières, Quebec, Canada, G8T 7A1
        • GSK Investigational Site
  • Denmark
      • Aarhus, Denmark, DK-8000
        • GSK Investigational Site
      • Frederiksberg, Denmark, 2000
        • GSK Investigational Site
  • Estonia
      • Tallinn, Estonia, 13419
        • GSK Investigational Site
      • Tartu, Estonia, 51014
        • GSK Investigational Site
  • France
      • Créteil, France, 94000
        • GSK Investigational Site
      • Mont de Marsan, France, 40000
        • GSK Investigational Site
      • Toulouse, France, 31300
        • GSK Investigational Site
      • Tours, France, 37000
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • GSK Investigational Site
      • Berlin, Germany, 12163
        • GSK Investigational Site
    • Bayern
      • Kuenzing, Bayern, Germany, 94550
        • GSK Investigational Site
    • Niedersachsen
      • Northeim, Niedersachsen, Germany, 37154
        • GSK Investigational Site
      • Weyhe-Leeste, Niedersachsen, Germany, 28844
        • GSK Investigational Site
    • Sachsen
      • Chemnitz, Sachsen, Germany, 09113
        • GSK Investigational Site
      • Ebersbach, Sachsen, Germany, 02730
        • GSK Investigational Site
      • Koenigsbrueck, Sachsen, Germany, 01936
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04177
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04299
        • GSK Investigational Site
      • Leisnig, Sachsen, Germany, 04703
        • GSK Investigational Site
      • Markkleeberg, Sachsen, Germany, 04416
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Wolmirstedt, Sachsen-Anhalt, Germany, 39326
        • GSK Investigational Site
    • Schleswig-Holstein
      • Bad Segeberg, Schleswig-Holstein, Germany, 23795
        • GSK Investigational Site
    • Thueringen
      • Jena, Thueringen, Germany, 07743
        • GSK Investigational Site
  • Greece
      • Athens, Greece, 115 28
        • GSK Investigational Site
      • Athens, Greece, 123 51
        • GSK Investigational Site
  • Hungary
      • Sopron, Hungary, 9400
        • GSK Investigational Site
      • Szolnok, Hungary, 5004
        • GSK Investigational Site
      • Szolnok, Hungary, 5000
        • GSK Investigational Site
      • Székesfehérvár, Hungary, 8000
        • GSK Investigational Site
  • India
      • Bangalore, India, 560034
        • GSK Investigational Site
      • Bangalore, India
        • GSK Investigational Site
      • Hyderabad, India, 500063
        • GSK Investigational Site
      • Mumbai, India, 400008
        • GSK Investigational Site
      • New Delhi, India, 110065
        • GSK Investigational Site
  • Italy
    • Calabria
      • Catanzaro, Calabria, Italy, 88100
        • GSK Investigational Site
    • Campania
      • Caserta, Campania, Italy, 81100
        • GSK Investigational Site
    • Lazio
      • Roma, Lazio, Italy, 00163
        • GSK Investigational Site
    • Umbria
      • Città della Pieve (PG), Umbria, Italy, 06062
        • GSK Investigational Site
  • Korea, Republic of
      • Kwangju, Korea, Republic of
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 120-752
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 110-744
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 152-703
        • GSK Investigational Site
  • Latvia
      • Riga, Latvia, LV 1002
        • GSK Investigational Site
      • Riga, Latvia, LV1001
        • GSK Investigational Site
  • Mexico
      • Mexico, Mexico, 11850
        • GSK Investigational Site
  • Netherlands
      • Delft, Netherlands, 2625 AD
        • GSK Investigational Site
      • Den Haag, Netherlands, 2597 AX
        • GSK Investigational Site
      • Utrecht, Netherlands, 3582 KE
        • GSK Investigational Site
  • New Zealand
      • Auckland, New Zealand
        • GSK Investigational Site
      • Christchurch, New Zealand, 8001
        • GSK Investigational Site
      • Hamilton, New Zealand, 2001
        • GSK Investigational Site
      • Takapuna, Auckland, New Zealand, 1309
        • GSK Investigational Site
  • Norway
      • Elverum, Norway, 2408
        • GSK Investigational Site
      • Oslo, Norway, N-0160
        • GSK Investigational Site
      • Skien, Norway, N-3710
        • GSK Investigational Site
  • Romania
      • Bucharest, Romania, 020125
        • GSK Investigational Site
      • Bucuresti, Romania
        • GSK Investigational Site
      • Targu-Mures, Romania
        • GSK Investigational Site
  • Spain
      • Alicante, Spain, 03114
        • GSK Investigational Site
      • Alicante, Spain, 03010
        • GSK Investigational Site
      • Barcelona, Spain, 08036
        • GSK Investigational Site
      • Cadiz, Spain, 11009
        • GSK Investigational Site
      • Leganes, Spain
        • GSK Investigational Site
      • Madrid, Spain, 28006
        • GSK Investigational Site
      • Madrid, Spain, 28040
        • GSK Investigational Site
      • Madrid, Spain, 28035
        • GSK Investigational Site
      • San Juan De Alicante, Spain, 3550
        • GSK Investigational Site
  • Sweden
      • Göteborg, Sweden, SE-413 45
        • GSK Investigational Site
      • Stockholm, Sweden, SE-111 57
        • GSK Investigational Site
      • Uppsala, Sweden, SE-751 85
        • GSK Investigational Site
  • Taiwan
      • Taipei, Taiwan, 112
        • GSK Investigational Site
  • Thailand
      • Bangkok, Thailand, 10400
        • GSK Investigational Site
      • Chiangmai, Thailand, 50200
        • GSK Investigational Site
  • United Kingdom
      • Antrim, United Kingdom, BT41 2RL
        • GSK Investigational Site
      • Dundee, United Kingdom, DD1 9SY
        • GSK Investigational Site
      • Manchester, United Kingdom, M23 9LT
        • GSK Investigational Site
      • York, United Kingdom, YO31 8HE
        • GSK Investigational Site
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G11 6NT
        • GSK Investigational Site
    • Middlesex
      • Harrow, Middlesex, United Kingdom, HA1 1QL
        • GSK Investigational Site
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • GSK Investigational Site
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B18 7QH
        • GSK Investigational Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • GSK Investigational Site
    • Michigan
      • Troy, Michigan, United States, 48098
        • GSK Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44313
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45224
        • GSK Investigational Site
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19140
        • GSK Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • GSK Investigational Site
    • Washington
      • Walla Walla, Washington, United States, 99362
        • GSK Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Relationship between anti IIa (a biomarker)and the dose of SB424323.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (ACTUAL)

December 1, 2006

Study Completion (ACTUAL)

December 1, 2006

Study Registration Dates

First Submitted

October 14, 2005

First Submitted That Met QC Criteria

October 14, 2005

First Posted (ESTIMATE)

October 18, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 16, 2017

Last Update Submitted That Met QC Criteria

January 13, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101724

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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