RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00379769

Purpose

This study is a phase 3b, multicentre, randomised, open label, parallel group study. A 4-week run-in period will be followed by a median of 6 years of treatment with study medication in addition to continuation of background glucose lowering therapy. Patients inadequately controlled on background metformin will be randomised to receive, in addition to metformin, either rosiglitazone or a sulfonylurea(glibenclamide, gliclazide or glimepiride) in a ratio of 1:1. Patients inadequately controlled on background SU will be randomised to receive, in addition to SU, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of patients receiving background metformin and SU at entry will be entered into the study.

Condition	Intervention	Phase
Type II Diabetes	Drug: Rosiglitazone in addition to background metformin Drug: Rosiglitazone in addition to background sulfonylurea Drug: Metformin in addition to background sulfonylurea Drug: Sulfonylurea in addition to background metformin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety Study
Official Title:	A Long Term, Open Label, Randomised Study in Patients With Type 2 Diabetes, Comparing the Combination of Rosiglitazone and Either Metformin or Sulfonylurea With Metformin Plus Sulfonylurea on Cardiovascular Endpoints and Glycaemia

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Rosiglitazone Rosiglitazone Maleate Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of Participants With Cardiovascular Events and All-cause Deaths [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]
Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]
Number of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by Stratum [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]
Number of Participants With CV/Microvascular Events [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]
Number of Participants With Glycaemic Failure Events [ Time Frame: Baseline through to end of randomised dual therapy ] [ Designated as safety issue: No ]
Number of Participants With Addition of Third Oral Agent/Switch to Insulin [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]
The Number of Participants Starting Insulin at Any Time During the Study [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]
Model Adjusted Change From Baseline in HbA1c at Month 60 [ Time Frame: Baseline and Month 60 of randomised dual therapy treatment period ] [ Designated as safety issue: No ]
Model Adjusted Change From Baseline in Fasting Plasma Glucose at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment period ] [ Designated as safety issue: No ]
Model Adjusted Mean Change From Baseline in Insulin and Pro-insulin at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment period ] [ Designated as safety issue: No ]
Number of HbA1c and Fasting Plasma Glucose (FPG) Responders at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment period ] [ Designated as safety issue: No ]
Model Adjusted Ratio to Baseline (Expressed as a Percentage) Homeostasis Model Assessment (HOMA) Beta Cell Function and Insulin Sensitivity at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment phase ] [ Designated as safety issue: No ]
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Triglycerides, and Free Fatty Acids at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment phase ] [ Designated as safety issue: No ]
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholersterol:High-density Lipoprotein (HDL) Cholesterol and Low-density Lipoprotein (LDL) Cholesterol:HDL Cholesterol Ratios at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment period ] [ Designated as safety issue: No ]
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Apolipoprotein B (Apo-B) at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment period ] [ Designated as safety issue: No ]
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Urinary Albumin Creatinine Ratio at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment phase ] [ Designated as safety issue: No ]
Model Adjusted Change From Baseline in Body Weight at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment phase ] [ Designated as safety issue: No ]
Model Adjusted Change From Baseline in Alanine Aminotransferase at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment phase ] [ Designated as safety issue: No ]
Model Adjusted Change From Baseline in Waist Circumference at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment phase ] [ Designated as safety issue: No ]
Model Adjusted Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment phase ] [ Designated as safety issue: No ]
Model Adjusted Change From Baseline in C- Reactive Protein (CRP) at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment phase ] [ Designated as safety issue: No ]
Model Adjusted Change From Baseline in Fibrinogen at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment phase ] [ Designated as safety issue: No ]
Model Adjusted Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) Antigen at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment phase ] [ Designated as safety issue: No ]

Enrollment:	4447
Study Start Date:	April 2001
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
add-on medication: Active Comparator A 4-week run-in period will be followed by a median of 6 years of treatment with study medication in addition to continuation of background glucose lowering therapy. Patients inadequately controlled on background metformin will be randomised to receive, in addition to metformin, either rosiglitazone or an SU (glibenclamide, gliclazide or glimepiride) in a ratio of 1:1. Patients inadequately controlled on background Su will be randomised to receive, in addition to Su, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of patients receiving background metformin and SU at entry will be entered into the study.	Drug: Rosiglitazone in addition to background metformin Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent. Drug: Rosiglitazone in addition to background sulfonylurea Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent. Drug: Metformin in addition to background sulfonylurea Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent. Drug: Sulfonylurea in addition to background metformin Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.

Arms

Assigned Interventions

add-on medication: Active Comparator

A 4-week run-in period will be followed by a median of 6 years of treatment with study medication in addition to continuation of background glucose lowering therapy. Patients inadequately controlled on background metformin will be randomised to receive, in addition to metformin, either rosiglitazone or an SU (glibenclamide, gliclazide or glimepiride) in a ratio of 1:1. Patients inadequately controlled on background Su will be randomised to receive, in addition to Su, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of patients receiving background metformin and SU at entry will be entered into the study.

Drug: Rosiglitazone in addition to background metformin

Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.

Drug: Rosiglitazone in addition to background sulfonylurea

Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.

Drug: Metformin in addition to background sulfonylurea

Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.

Drug: Sulfonylurea in addition to background metformin

Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379769

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Locations

Australia, New South Wales
GSK Investigational Site
Miranda, New South Wales, Australia, 2228
GSK Investigational Site
Wollongong, New South Wales, Australia, 2500
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Randwick, New South Wales, Australia, 2031
Australia, Queensland
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Sherwood, Queensland, Australia, 4075
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Carina Heights, Queensland, Australia, 4152
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Kippa Ring, Queensland, Australia, 4021
Australia, South Australia
GSK Investigational Site
North Adelaide, South Australia, Australia, 5006
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Keswick, South Australia, Australia, 5035
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Port Lincoln, South Australia, Australia, 5606
Australia, Victoria
GSK Investigational Site
Malvern, Victoria, Australia, 3144
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Heidelberg West, Victoria, Australia, 3081
Belgium
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Moerkerke, Belgium, 8340
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Genk, Belgium, 3600
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Gent, Belgium, 9000
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Edegem, Belgium, 2650
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Oostham, Belgium, 3945
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Liege, Belgium, 4000
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Gent, Belgium, 9000
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Sint Gillis-Waas, Belgium, 9170
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Antwerpen, Belgium, 2000
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Brussels, Belgium, 1090
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Vilvoorde, Belgium, 1800
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Arlon, Belgium, 6700
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Roeselare, Belgium, 8800
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Kortrijk, Belgium, 8500
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Willebroek, Belgium, 2830
Bulgaria
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Sofia, Bulgaria, 1606
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Sofia, Bulgaria, 1303
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Sofia, Bulgaria, 1431/1000
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Sofia, Bulgaria, 1301
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Plovdiv, Bulgaria, 4002
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Varna, Bulgaria, 9010
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Sofia, Bulgaria, 1233
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Pleven, Bulgaria, 5800
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Sofia, Bulgaria
Croatia
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Zagreb, Croatia, 10000
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Krapinske Toplice, Croatia, 49217
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Slavonski Brod, Croatia, 35000
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Rijeka, Croatia, 51000
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Varaždin, Croatia, 42000
Czech Republic
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Rakovnik, Czech Republic, 269 01
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Holice V Cechach, Czech Republic, 534 01
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Ceske Budejovice, Czech Republic, 370 87
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Praha 4, Czech Republic, 140 00
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Tabor, Czech Republic, 390 00
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Hradec Kralove, Czech Republic, 500 05
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Pisek, Czech Republic, 397 01
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Praha 2, Czech Republic, 128 42
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Ostrava Poruba, Czech Republic, 708 52
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Jindrichuv Hradec, Czech Republic, 377 38
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Trutnov, Czech Republic, 541 21
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Brno, Czech Republic, 625 00
Denmark
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København Nv, Denmark
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Naestved, Denmark, 4700
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Slagelse, Denmark, 4200
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Aalborg, Denmark, DK-9100
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Kolding, Denmark, DK-6000
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Glostrup, Denmark
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Aarhus, Denmark
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Odense C, Denmark, DK-5000
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Silkeborg, Denmark, 8600
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Copenhagen, Denmark, 2300
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Hilleroed, Denmark, 3400
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Koge, Denmark, 4600
Estonia
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Tallinn, Estonia, 10138
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Rakvere, Estonia, 44316
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Paide, Estonia, 72714
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Saku, Estonia, 75501
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Viljandi, Estonia, 71024
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Tallinn, Estonia, 11911
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Parnu, Estonia, 80018
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Tallinn, Estonia, 13415
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Tallinn, Estonia, 1162
Finland
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Riihimäki, Finland, 11130
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Lappeenranta, Finland, 53100
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Turku, Finland, 20100
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Rovaniemi, Finland
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Kerava, Finland, 04200
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Kuopio, Finland, 70210
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Seinajoki, Finland, 60220
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Lahti, Finland, 15850
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Helsinki, Finland, 00810
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Espoo, Finland, 02600
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Hanko, Finland, 10900
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Helsinki, Finland, 00930
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Tampere, Finland, 33100
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Espoo, Finland, 02710
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Hyvinkaa, Finland, 05800
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Helsinki, Finland, 00150
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Jyväskylä, Finland, 40100
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Turku, Finland, 20700
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Oulun Kaupunki, Finland, 90015
France
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Marseille, France, 13008
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Castelnaudary, France, 11400
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Nevers Cedex, France, 58033
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Valenciennes, France, 59322
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Broglie, France, 27270
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Voves, France, 28150
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Chartres, France, 28000
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La Barre En Ouche, France, 27330
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Thann, France, 68800
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Dessenheim, France, 68600
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Belpech, France, 11420
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Nassandres, France, 27550
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Hanches, France, 28130
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Labarthe-Sur-Leze, France, 31860
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Masevaux, France, 68290
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Kembs, France, 68680
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Epernon, France, 28230
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Azille, France, 11700
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Roux Mesnil Bouteille, France, 76370
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Saint-Eulalie Badens, France, 11800
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Saint Leger Sur Yvelines, France, 78610
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Blotzheim, France
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Marseille, France, 13011
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Dieppe, France, 76200
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Beaumont Sur Leze, France, 31870
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Maubeuge, France, 59600
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Hautot Sur Mer, France, 76550
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Le Grau Du Roi, France, 30240
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Dunkerque, France, 59385
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Toulouse, France, 31500
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Champhol, France, 28300
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Thiberville, France, 27230
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Marseille, France, 13001
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Bondy, France, 93143
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Rugles, France, 27250
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Muret, France, 31600
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Cernay, France, 68700
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Toulouse, France, 31000
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Belfort, France, 90000
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Carbonne, France, 31390
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Danjoutin, France, 90400
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Nogent Le Phaye, France, 28630
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Cuincy, France, 59553
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Lezignan-Corbières, France, 11200
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Marseille, France, 13003
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Pierres, France, 28130
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Trebes, France, 11800
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Le Perray En Yvelines, France, 78610
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Cassis, France, 13260
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Carcassonne, France, 11000
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Arras, France, 62000
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Le Lherm 31600, France, 31600
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Gemenos, France, 13420
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Colmar, France, 68000
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Marseille, France, 13014
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Husseren Wesserling, France, 68470
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Aubagne, France, 13400
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Amilly, France, 28300
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Labarth-Sur-Leze, France, 31860
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Coursan, France, 11110
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Maintenon, France, 28130
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Catelnaudary, France, 11400
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Pierre Benite Cedex, France, 69495
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Marseille, France, 13016
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Toulouse, France, 31400
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Trebbes, France, 01800
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Monfort Sur Risle, France, 27290
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Marseille, France, 13013
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Mulhouse, France, 68100
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Beaumont Le Roger, France, 21170
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Aspach Le Bas 68700, France, 68700
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Carcassonne 11000, France, 11000
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Calmont, France, 31560
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Gemenos, France, 13420
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La Verdière, France, 83560
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Toulouse, France, 31500
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Pinsaguel, France, 31120
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Wittenheim, France, 68270
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Corbeil Essonne, France, 91014
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Orbec, France, 14290
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Vogelsheim, France, 68600
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Auchy Les Hesdin, France, 62770
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Seysses, France, 31600
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Paris Cedex 13, France, 75651
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Nogent Le Rotrou, France, 28400
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Bp 1542 Dijon, France, 21034
France, Nord-Pas-de-Calais
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Bully Les Mines, Nord-Pas-de-Calais, France, 62160
Germany
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Stuttgart, Germany, 70197
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Friedrichsthal, Germany, 66299
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Heidelberg, Germany, 69120
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Leipzig, Germany, 04103
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Hamburg, Germany, 20249
Germany, Baden-Wuerttemberg
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Sinsheim, Baden-Wuerttemberg, Germany, 74889
Germany, Bayern
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Kronach, Bayern, Germany, 96317
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Wuerzburg, Bayern, Germany, 97070
Germany, Hessen
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Offenbach, Hessen, Germany, 63071
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Wetzlar, Hessen, Germany, 35578
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Kronberg, Hessen, Germany, 61476
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Ober-Moerlen, Hessen, Germany, 61239
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Frankfurt, Hessen, Germany, 60487
Germany, Niedersachsen
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Bad Lauterberg, Niedersachsen, Germany, 37424
Germany, Nordrhein-Westfalen
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Beckum, Nordrhein-Westfalen, Germany, 59269
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Menden, Nordrhein-Westfalen, Germany, 58706
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Remscheid, Nordrhein-Westfalen, Germany, 42897
Germany, Rheinland-Pfalz
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Kallstadt, Rheinland-Pfalz, Germany, 67169
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Speyer, Rheinland-Pfalz, Germany, 67346
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Lambrecht, Rheinland-Pfalz, Germany, 67466
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Rhaunen, Rheinland-Pfalz, Germany, 55624
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Gau-Algesheim, Rheinland-Pfalz, Germany, 55435
Germany, Sachsen
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Dresden, Sachsen, Germany, 01307
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Chemnitz, Sachsen, Germany, 09130
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Burgstaedt, Sachsen, Germany, 09217
Germany, Thueringen
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Suhl, Thueringen, Germany, 98529
Greece
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Ioannina, Greece, 45001
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Patra, Greece, 26500
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Haidari, Athens, Greece, 12462
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Piraeus-Athens, Greece, 18536
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Athens, Greece, 11527
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Athens, Greece, 11521
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Piraeus-Athens, Greece, 18454
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Athens, Greece, 18537
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Patra, Greece, 26335
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Thessaloniki, Greece, 564 29
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Thessalonikis, Greece, 57010
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Athens, Greece, 115 27
Hungary
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Gyor, Hungary, 9024
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Gyula, Hungary, 5701
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Budapest, Hungary, 1062
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Budapest, Hungary, 1097
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Kurtag99, Hungary
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Budapest, Hungary, 1096
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Budapest, Hungary, 1115
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Veszprem, Hungary, 8200
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Patkaj98, Hungary
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Budapest, Hungary, 1125
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Eger, Hungary
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Nyiregyháza, Hungary, 4400
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Budapest, Hungary, 1083
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Budapest, Hungary, 1145
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Zalaegerszeg, Hungary, 8900
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Szentes, Hungary, 6600
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Szombathely, Hungary, 9700
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Debrecen, Hungary, 4043
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Siofok, Hungary, 8601
Italy
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Roma, Italy, 00168
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Parma, Italy, 43100
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Bari, Italy, 70124
Italy, Abruzzo
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Teramo, Abruzzo, Italy, 64100
Italy, Calabria
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Reggio Calabria, Calabria, Italy, 89100
Italy, Campania
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Nocera Inferiore (sa), Campania, Italy, 84014
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Salerno, Campania, Italy, 84100
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Napoli, Campania, Italy, 80136
Italy, Emilia-Romagna
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Rimini, Emilia-Romagna, Italy, 47900
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Bologna, Emilia-Romagna, Italy, 40138
Italy, Lazio
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Roma, Lazio, Italy, 00155
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Roma, Lazio, Italy, 00168
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Roma, Lazio, Italy, 00149
Italy, Liguria
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Genova, Liguria, Italy, 16132
Italy, Lombardia
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Milano, Lombardia, Italy, 20162
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Treviglio (bg), Lombardia, Italy, 13115
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Brescia, Lombardia, Italy, 25123
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San Donato (mi), Lombardia, Italy, 20097
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Bergamo, Lombardia, Italy, 24128
Italy, Marche
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Torrette (an), Marche, Italy, 60020
Italy, Molise
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Campobasso, Molise, Italy, 86100
Italy, Piemonte
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Torino, Piemonte, Italy, 10122
Italy, Sardegna
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Sassari, Sardegna, Italy, 07100
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Cagliari, Sardegna, Italy, 09127
Italy, Sicilia
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Palermo, Sicilia, Italy, 90127
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Catania, Sicilia, Italy, 95124
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Caltanissetta, Sicilia, Italy, 93100
Italy, Toscana
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Pisa, Toscana, Italy, 56126
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Firenze, Toscana, Italy, 50139
Latvia
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Riga, Latvia, 1006
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Jekabpils, Latvia, LV 5201
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Riga, Latvia, LV 1057
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Riga, Latvia, LV 1011
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Ogre, Latvia, LV 5001
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Sturii59, Latvia
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Tukums, Latvia, LV 3100
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Limbazi, Latvia, LV 4001
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Riga, Latvia, LV1002
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Lagzdi60, Latvia
Lithuania
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Vilnius, Lithuania, LT 08661
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Kaunas, Lithuania, LT-51270
GSK Investigational Site
Vilnius, Lithuania, LT-04318
GSK Investigational Site
Kaunas, Lithuania, LT-50009
GSK Investigational Site
Kaunas, Lithuania, LT-49476
GSK Investigational Site
Klaipeda, Lithuania, 92304
Netherlands
GSK Investigational Site
Rotterdam, Netherlands, 3082 KC
GSK Investigational Site
Geleen, Netherlands, 6160 BB
GSK Investigational Site
Zoetermeer, Netherlands, 2724 EK
GSK Investigational Site
Nijmegen, Netherlands, 6525 EC
GSK Investigational Site
Groningen, Netherlands, 9711 SG
GSK Investigational Site
St. Willebrord, Netherlands, 4711 EG
GSK Investigational Site
Landgraaf, Netherlands, 6373 JS
GSK Investigational Site
Musselkanaal, Netherlands, 9581 AD
GSK Investigational Site
Hoogvliet, Netherlands, 3192 JN
GSK Investigational Site
Zwijndrecht, Netherlands, 3331 AE
GSK Investigational Site
Rotterdam, Netherlands, 3021 HC
GSK Investigational Site
Oude Pekela, Netherlands, 9665 AR
GSK Investigational Site
Kerkrade, Netherlands, 6461 XP
GSK Investigational Site
Rijswijk, Netherlands, 2281 AK
GSK Investigational Site
Hengelo, Netherlands, 7555 DL
GSK Investigational Site
Ridderkerk, Netherlands, 2985 BV
New Zealand
GSK Investigational Site
Tauranga, New Zealand, 3112
GSK Investigational Site
Takapuna, Auckland, New Zealand, 0620
GSK Investigational Site
Christchurch, New Zealand, 8011
GSK Investigational Site
Otahuhu, Auckland, New Zealand, 2025
GSK Investigational Site
Dunedin, New Zealand, 9016
GSK Investigational Site
Palmerston North, New Zealand, 4410
GSK Investigational Site
Wellington, New Zealand, 6002
GSK Investigational Site
Hastings, New Zealand, Private Bag 9014
Poland
GSK Investigational Site
Wroclaw, Poland, 50-127
GSK Investigational Site
Warszawa, Poland, 01-337
GSK Investigational Site
Lublin, Poland, 02 081
GSK Investigational Site
Olsztyn, Poland, 10 461
GSK Investigational Site
Bydgoszcz, Poland, 85 822
GSK Investigational Site
Krakow, Poland, 31 501
GSK Investigational Site
Warszawa, Poland, 02-042
GSK Investigational Site
Poznan, Poland, 60-834
GSK Investigational Site
Lodz, Poland, 90 030
GSK Investigational Site
Poznan, Poland, 61 696
GSK Investigational Site
Gdansk, Poland, 80 211
GSK Investigational Site
Krakow, Poland, 31 261
GSK Investigational Site
Lublin, Poland, 20-718
GSK Investigational Site
Grudziadz, Poland, 86-300
GSK Investigational Site
Bialystok, Poland, 15-276
GSK Investigational Site
Warszawa, Poland, 02 507
GSK Investigational Site
Warszawa, Poland, 01 887
Romania
GSK Investigational Site
Cluj-Napoca, Romania, 400006
GSK Investigational Site
Timisoara, Romania, 293406
GSK Investigational Site
Bucuresti, Romania, 011234
GSK Investigational Site
Iasi, Romania, 700111
GSK Investigational Site
Craiova, Romania, 2000642
GSK Investigational Site
Bucharest, Romania, 020475
GSK Investigational Site
Bucuresti, Romania, 022448
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 115 280
GSK Investigational Site
Moscow, Russian Federation, 117049
GSK Investigational Site
St Petersburg, Russian Federation, 195257
GSK Investigational Site
Moscow, Russian Federation, 129110
GSK Investigational Site
Moscow, Russian Federation, 125315
GSK Investigational Site
St-Petersburg, Russian Federation, 194291
GSK Investigational Site
Moscow, Russian Federation, 119992
Slovakia
GSK Investigational Site
Prievidza, Slovakia, 97201
GSK Investigational Site
Banska Bystrica, Slovakia, 975 17
GSK Investigational Site
Bratislava, Slovakia, 811 08
GSK Investigational Site
Bratislava, Slovakia, 82102
GSK Investigational Site
Presov, Slovakia, 08001
GSK Investigational Site
Kosice, Slovakia, 040 11
GSK Investigational Site
Trencin, Slovakia, 911 01
GSK Investigational Site
Lucenec, Slovakia, 984 01
GSK Investigational Site
Bratislava, Slovakia, 813 69
GSK Investigational Site
Samorin, Slovakia, 931 01
GSK Investigational Site
Lubochna, Slovakia, 034 91
GSK Investigational Site
Kosice, Slovakia, 041 90
GSK Investigational Site
Kysucke Nove Mesto, Slovakia, 024 01
GSK Investigational Site
Zilina, Slovakia, 010 01
GSK Investigational Site
Sahy, Slovakia, 936 01
GSK Investigational Site
Bratislava, Slovakia, 82108
Spain
GSK Investigational Site
Bilbao, Spain, 48903
GSK Investigational Site
Granada, Spain, 18012
GSK Investigational Site
Vizcaya, Spain, 48910
GSK Investigational Site
Benidorm, Spain, 03500
GSK Investigational Site
Vazquc56, Spain
GSK Investigational Site
Cadiz, Spain, 11009
GSK Investigational Site
Vizcaya, Spain, 48920
GSK Investigational Site
Madrid, Spain, 28040
GSK Investigational Site
Palma de Mallorca, Spain, 7014
GSK Investigational Site
Reus, Spain, 43201
GSK Investigational Site
Madrid, Spain, 28034
GSK Investigational Site
Madrid, Spain, 28040
GSK Investigational Site
Badalona, Spain, 08911
GSK Investigational Site
Caceres, Spain, 10003
GSK Investigational Site
Barcelona, Spain, 08025
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Santander, Spain, 38008
GSK Investigational Site
Alzira, Spain, 46600
Sweden
GSK Investigational Site
Göteborg, Sweden, SE-416 65
GSK Investigational Site
Skene, Sweden, SE-511 62
GSK Investigational Site
Norrköping, Sweden, SE-602 20
GSK Investigational Site
Nacka, Sweden, SE-131 83
GSK Investigational Site
Köping, Sweden, SE-73181
GSK Investigational Site
Uppsala, Sweden, SE-751 25
GSK Investigational Site
Kungälv, Sweden, SE-442 83
GSK Investigational Site
Lund, Sweden, SE-221 85
GSK Investigational Site
Stockholm, Sweden, SE-182 88
GSK Investigational Site
Göteborg, Sweden, SE-413 45
GSK Investigational Site
Kristianstad, Sweden, SE-291 85
GSK Investigational Site
Göteborg, Sweden, SE-417 17
GSK Investigational Site
Eksjö, Sweden, SE-575 81
GSK Investigational Site
Oskarshamn, Sweden, SE-572 28
GSK Investigational Site
Linköpiing, Sweden, SE-582 25
GSK Investigational Site
Uddevalla, Sweden, SE-451 40
GSK Investigational Site
Umeå, Sweden, SE-901 85
GSK Investigational Site
Helsingborg, Sweden, SE-254 37
GSK Investigational Site
Vadstena, Sweden, SE-592 32
GSK Investigational Site
Mora, Sweden, SE-792 85
Ukraine
GSK Investigational Site
Dnepropetrovsk, Ukraine, 49023
GSK Investigational Site
Vinnitsa, Ukraine, 21010
GSK Investigational Site
Kiev, Ukraine, 04114
GSK Investigational Site
Kiev, Ukraine, 02175
GSK Investigational Site
Lvov, Ukraine, 79010
GSK Investigational Site
Kharkiv, Ukraine, 61002
GSK Investigational Site
Kyiv, Ukraine, 01004
United Kingdom
GSK Investigational Site
Woking, United Kingdom, GU21 1TD
GSK Investigational Site
Colney, United Kingdom, NR4 7UY
GSK Investigational Site
Newcastle Upon Tyne, United Kingdom, NE1 4LP
GSK Investigational Site
Wishaw, United Kingdom, ML2 7BQ
GSK Investigational Site
Motherwell, United Kingdom, ML1 2PS
GSK Investigational Site
Rubery, Birmingham, United Kingdom, B45 9JT
GSK Investigational Site
Weston Super Mare, United Kingdom, BS23 4BP
GSK Investigational Site
Old Whittington, Chesterfield, United Kingdom, S41 9JZ
GSK Investigational Site
Glasgow, United Kingdom, G5 OPQ
GSK Investigational Site
Penzance, United Kingdom, TR18 4JH
GSK Investigational Site
Falmouth, United Kingdom, TR11 2LH
GSK Investigational Site
Uddingston, United Kingdom, G71 5SU
GSK Investigational Site
Chesterfield, United Kingdom, S40 1LE
GSK Investigational Site
Leigh on Sea, United Kingdom, SS9 2SQ
GSK Investigational Site
Cumbernauld, United Kingdom, G67 3BE
GSK Investigational Site
Airdrie, United Kingdom, ML6 0JH
GSK Investigational Site
Airdrie, United Kingdom, ML6 0JU
GSK Investigational Site
Dronfield, United Kingdom, S18 1RU
GSK Investigational Site
Glasgow, United Kingdom
GSK Investigational Site
Sheffield, United Kingdom, S5 7TW
GSK Investigational Site
Bath, United Kingdom, BA2 3HT
GSK Investigational Site
Hamilton, United Kingdom, ML3 8AA
GSK Investigational Site
Worle, Weston-Super-Mare, United Kingdom, BS22 6AJ
GSK Investigational Site
Paisley, United Kingdom, PA3 2DY
GSK Investigational Site
Thornhill, Cardiff, United Kingdom, CF14 9BB
GSK Investigational Site
Gateshead, United Kingdom, NE9 6SX
GSK Investigational Site
Coatbridge, United Kingdom, ML5 3AP
GSK Investigational Site
Nottingham, United Kingdom, NG5 1PB
GSK Investigational Site
Sheffield, United Kingdom, S5 7QB
GSK Investigational Site
Chippenham, United Kingdom, SN15 2SB
GSK Investigational Site
Newport, United Kingdom, PO30 5TG
GSK Investigational Site
Garston, Watford, United Kingdom, WD2 6EB
GSK Investigational Site
Airdrie, United Kingdom, ML6 0JH
GSK Investigational Site
Ashford, United Kingdom, TW15 2TU
GSK Investigational Site
East Kilbride, United Kingdom, G75 8RG
GSK Investigational Site
Kirkintilloch, United Kingdom, G66 1JB
GSK Investigational Site
Thornhill, United Kingdom, DG3 5AA
GSK Investigational Site
Dumbarton, United Kingdom, G82 1PW
GSK Investigational Site
Harrow, United Kingdom, HA3 7LT
United Kingdom, Cambridgeshire
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
United Kingdom, Cornwall
GSK Investigational Site
Fowley, Cornwall, United Kingdom, PL23 1DT
United Kingdom, Derbyshire
GSK Investigational Site
Chesterfield, Derbyshire, United Kingdom, S40 4TF
GSK Investigational Site
Chesterfield, Derbyshire, United Kingdom, S44 6DE
United Kingdom, Lanarkshire
GSK Investigational Site
Airdrie, Lanarkshire, United Kingdom, ML6 0JS
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G51 4TF
GSK Investigational Site
Hamilton, Lanarkshire, United Kingdom, ML3 0DR
GSK Investigational Site
Motherwell, Lanarkshire, United Kingdom, ML1 3JX
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom
United Kingdom, Leicestershire
GSK Investigational Site
Leicester, Leicestershire, United Kingdom, LE1 5WW
United Kingdom, Northamptonshire
GSK Investigational Site
Northampton, Northamptonshire, United Kingdom, NN1 5BD
GSK Investigational Site
Northampton, Northamptonshire, United Kingdom, NN5 7AQ
United Kingdom, Renfrewshire
GSK Investigational Site
Paisley, Renfrewshire, United Kingdom, PA1 1UB
GSK Investigational Site
Linwood, Renfrewshire, United Kingdom
United Kingdom, Somerset
GSK Investigational Site
Frome, Somerset, United Kingdom, BA11 1EZ
GSK Investigational Site
Glastonbury, Somerset, United Kingdom, BA6 9LP
United Kingdom, Warwickshire
GSK Investigational Site
Rugby, Warwickshire, United Kingdom, CV22 5PX
GSK Investigational Site
Rugby, Warwickshire, United Kingdom, CV21 3SP
United Kingdom, Wiltshire
GSK Investigational Site
Corsham, Wiltshire, United Kingdom, SN13 9DL
GSK Investigational Site
Trowbridge, Wiltshire, United Kingdom, BA14 9AR
GSK Investigational Site
Westbury, Wiltshire, United Kingdom, BA13 3JD
GSK Investigational Site
Trowbridge, Wiltshire, United Kingdom, BA14 8QA

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	BRL-049653/231
Study First Received:	September 21, 2006
Results First Received:	August 24, 2009
Last Updated:	November 20, 2009
ClinicalTrials.gov Identifier:	NCT00379769 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency