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

NCT00240643 | Completed Phase 2

• 1 other identifier: 101724
• Study Type: interventional
• Target: 640
• Locations: 24 countries
• Sites: 114

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.

Conditions

Fibrillation, Atrial; Atrial Fibrillation

Keywords

non valvular atrial fibrillation; stroke; aspirin

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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.

Interventions

SB424323 DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with non valvular atrial fibrillation and any of the following:
• \</= 60 years old with no heart disease.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (116)

GSK Investigational Site

Mobile, Alabama, 36608, United States

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GSK Investigational Site

Troy, Michigan, 48098, United States

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Akron, Ohio, 44313, United States

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Cincinnati, Ohio, 45224, United States

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Camp Hill, Pennsylvania, 17011, United States

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Philadelphia, Pennsylvania, 19140, United States

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Houston, Texas, 77030, United States

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Walla Walla, Washington, 99362, United States

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Milwaukee, Wisconsin, 53215, United States

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Buenos Aires, Buenos Aires, 1704, Argentina

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Capital Federal, Buenos Aires, C1180AAX, Argentina

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Capital Fefderal, Buenos Aires, Argentina

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Córdoba, Córdoba Province, 5000, Argentina

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Córdoba, Córdoba Province, 5003, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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Buenos Aires, 1221, Argentina

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Buenos Aires, 1405, Argentina

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Buenos Aires, 1428, Argentina

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Moron-Provincia de Buenos Aires, 1709, Argentina

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Antwerp, 2020, Belgium

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Linkebeek, 1630, Belgium

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Porto Alegre, Rio Grande do Sul, 40110-160, Brazil

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São Paulo, São Paulo, 04024-002, Brazil

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Halifax, Nova Scotia, B3K 5R3, Canada

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Truro, Nova Scotia, B2N 1L2, Canada

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Burlington, Ontario, L7M 4Y1, Canada

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Grimsby, Ontario, L3M 1P3, Canada

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Hamilton, Ontario, L8P 3B6, Canada

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Newmarket, Ontario, L3Y 8C3, Canada

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Toronto, Ontario, M3J 1N2, Canada

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Greenfield Park, Quebec, J4V 2G8, Canada

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Longueuil, Quebec, J4K 1E3, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Saint-Lambert, Quebec, J4P 2H4, Canada

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Trois-Rivières, Quebec, G8T 7A1, Canada

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GSK Investigational Site

Aarhus, DK-8000, Denmark

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Frederiksberg, 2000, Denmark

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Tallinn, 13419, Estonia

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Tartu, 51014, Estonia

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Créteil, 94000, France

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Mont-de-Marsan, 40000, France

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Toulouse, 31300, France

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Tours, 37000, France

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Künzing, Bavaria, 94550, Germany

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Northeim, Lower Saxony, 37154, Germany

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Weyhe-Leeste, Lower Saxony, 28844, Germany

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Chemnitz, Saxony, 09113, Germany

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Ebersbach, Saxony, 02730, Germany

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Königsbrück, Saxony, 01936, Germany

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Leipzig, Saxony, 04177, Germany

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Leipzig, Saxony, 04299, Germany

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Leisnig, Saxony, 04703, Germany

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Markkleeberg, Saxony, 04416, Germany

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Wolmirstedt, Saxony-Anhalt, 39326, Germany

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Bad Segeberg, Schleswig-Holstein, 23795, Germany

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Berlin, State of Berlin, 10117, Germany

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Berlin, State of Berlin, 12163, Germany

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Jena, Thuringia, 07743, Germany

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Athens, 115 28, Greece

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Athens, 123 51, Greece

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Sopron, 9400, Hungary

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Székesfehérvár, 8000, Hungary

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Szolnok, 5000, Hungary

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Szolnok, 5004, Hungary

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Bangalore, 560034, India

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Bangalore, India

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Hyderabad, 500063, India

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Mumbai, 400008, India

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New Delhi, 110065, India

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Catanzaro, Calabria, 88100, Italy

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Caserta, Campania, 81100, Italy

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Rome, Lazio, 00163, Italy

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Città Della Pieve (PG), Umbria, 06062, Italy

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Riga, LV 1002, Latvia

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Riga, LV1001, Latvia

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México, 11850, Mexico

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Delft, 2625 AD, Netherlands

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The Hague, 2597 AX, Netherlands

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Utrecht, 3582 KE, Netherlands

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Auckland, New Zealand

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Christchurch, 8001, New Zealand

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Hamilton, 2001, New Zealand

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Takapuna, Auckland, 1309, New Zealand

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Elverum, 2408, Norway

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Oslo, N-0160, Norway

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Skien, N-3710, Norway

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Bucharest, 020125, 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, 110-744, South Korea

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Seoul, 120-752, South Korea

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Seoul, 152-703, South Korea

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Alicante, 03010, Spain

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Alicante, 03114, Spain

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Barcelona, 08036, Spain

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GSK Investigational Site

Cadiz, 11009, Spain

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Leganés, Spain

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GSK Investigational Site

Madrid, 28006, Spain

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GSK Investigational Site

Madrid, 28035, Spain

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GSK Investigational Site

Madrid, 28040, Spain

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GSK Investigational Site

Sant Joan d'Alacant, 3550, Spain

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Gothenburg, SE-413 45, Sweden

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Stockholm, SE-111 57, Sweden

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Uppsala, SE-751 85, Sweden

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Taipei, 112, Taiwan

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Bangkok, 10400, Thailand

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Chiang Mai, 50200, Thailand

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Glasgow, Lanarkshire, G11 6NT, United Kingdom

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Harrow, Middlesex, HA1 1QL, United Kingdom

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Northwood, Middlesex, HA6 2RN, United Kingdom

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Birmingham, West Midlands, B18 7QH, United Kingdom

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Antrim, BT41 2RL, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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Manchester, M23 9LT, United Kingdom

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York, YO31 8HE, United Kingdom

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MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 18, 2005
• Study Start: November 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: January 16, 2017

Record last verified: 2017-01

Locations

IN (5); GR (2); CA (12); SE (3); HU (4); BR (2); DE (15); NZ (4); NL (3); RO (3); KR (4); ES (9); TH (2); AR (10); LA (2); US (9); BE (2); NO (3); DK (2); ME (1); TW (1); IT (4); FR (4); GB (8)