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

Atrial Fibrillation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240643
• Other study ID #: 101724
• Status: Completed
• Phase: Phase 2
• First received: October 14, 2005
• Last updated: January 13, 2017
• Start date: November 2005
• Est. completion date: December 2006

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Fibrillation, Atrial

Intervention

Drug:
• SB424323

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Capital Federal	Buenos Aires
Argentina	GSK Investigational Site	Capital Fefderal	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autónoma de Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autónoma de Buenos Aires
Argentina	GSK Investigational Site	Cordoba	Córdova
Argentina	GSK Investigational Site	Córdoba	Córdova
Argentina	GSK Investigational Site	Moron-Provincia de Buenos Aires
Argentina	GSK Investigational Site	Rosario	Santa Fe
Belgium	GSK Investigational Site	Antwerpen
Belgium	GSK Investigational Site	Linkebeek
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	GSK Investigational Site	São Paulo
Canada	GSK Investigational Site	Burlington	Ontario
Canada	GSK Investigational Site	Greenfield Park	Quebec
Canada	GSK Investigational Site	Grimsby	Ontario
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Hamilton	Ontario
Canada	GSK Investigational Site	Longueuil	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Newmarket	Ontario
Canada	GSK Investigational Site	St-Lambert	Quebec
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Trois Rivières	Quebec
Canada	GSK Investigational Site	Truro	Nova Scotia
Denmark	GSK Investigational Site	Aarhus
Denmark	GSK Investigational Site	Frederiksberg
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
France	GSK Investigational Site	Créteil
France	GSK Investigational Site	Mont de Marsan
France	GSK Investigational Site	Toulouse
France	GSK Investigational Site	Tours
Germany	GSK Investigational Site	Bad Segeberg	Schleswig-Holstein
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Chemnitz	Sachsen
Germany	GSK Investigational Site	Ebersbach	Sachsen
Germany	GSK Investigational Site	Jena	Thueringen
Germany	GSK Investigational Site	Koenigsbrueck	Sachsen
Germany	GSK Investigational Site	Kuenzing	Bayern
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leisnig	Sachsen
Germany	GSK Investigational Site	Markkleeberg	Sachsen
Germany	GSK Investigational Site	Northeim	Niedersachsen
Germany	GSK Investigational Site	Weyhe-Leeste	Niedersachsen
Germany	GSK Investigational Site	Wolmirstedt	Sachsen-Anhalt
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Hungary	GSK Investigational Site	Sopron
Hungary	GSK Investigational Site	Székesfehérvár
Hungary	GSK Investigational Site	Szolnok
Hungary	GSK Investigational Site	Szolnok
India	GSK Investigational Site	Bangalore
India	GSK Investigational Site	Bangalore
India	GSK Investigational Site	Hyderabad
India	GSK Investigational Site	Mumbai
India	GSK Investigational Site	New Delhi
Italy	GSK Investigational Site	Caserta	Campania
Italy	GSK Investigational Site	Catanzaro	Calabria
Italy	GSK Investigational Site	Città della Pieve (PG)	Umbria
Italy	GSK Investigational Site	Roma	Lazio
Korea, Republic of	GSK Investigational Site	Kwangju
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Mexico	GSK Investigational Site	Mexico
Netherlands	GSK Investigational Site	Delft
Netherlands	GSK Investigational Site	Den Haag
Netherlands	GSK Investigational Site	Utrecht
New Zealand	GSK Investigational Site	Auckland
New Zealand	GSK Investigational Site	Christchurch
New Zealand	GSK Investigational Site	Hamilton
New Zealand	GSK Investigational Site	Takapuna, Auckland
Norway	GSK Investigational Site	Elverum
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Skien
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Bucuresti
Romania	GSK Investigational Site	Targu-Mures
Spain	GSK Investigational Site	Alicante
Spain	GSK Investigational Site	Alicante
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Cadiz
Spain	GSK Investigational Site	Leganes
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	San Juan De Alicante
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Uppsala
Taiwan	GSK Investigational Site	Taipei
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Chiangmai
United Kingdom	GSK Investigational Site	Antrim
United Kingdom	GSK Investigational Site	Birmingham	West Midlands
United Kingdom	GSK Investigational Site	Dundee
United Kingdom	GSK Investigational Site	Glasgow	Lanarkshire
United Kingdom	GSK Investigational Site	Harrow	Middlesex
United Kingdom	GSK Investigational Site	Manchester
United Kingdom	GSK Investigational Site	Northwood	Middlesex
United Kingdom	GSK Investigational Site	York
United States	GSK Investigational Site	Akron	Ohio
United States	GSK Investigational Site	Camp Hill	Pennsylvania
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Mobile	Alabama
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Troy	Michigan
United States	GSK Investigational Site	Walla Walla	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between anti IIa (a biomarker)and the dose of SB424323.
Secondary	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.