Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers

This study has been terminated.
(Based on preliminary parent study results)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00490568
First received: June 21, 2007
Last updated: September 28, 2016
Last verified: September 2016
  Purpose
This is a Phase III, multicenter, open-label extension, single-group study in male and female outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed either AVA102670 or AVA102672. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4 weeks of the study followed by 8mg RSG XR as adjunctive therapy to their existing dose of acetylcholinesterase inhibitor. Subject participation will last until one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this study is to evaluate the long-term safety and tolerability of RSG XR in subjects with mild-to-moderate AD who have completed either AVA102670 or AVA102672. The secondary objective of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele status.

Condition Intervention Phase
Alzheimer's Disease
Drug: Rosiglitazone XR
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Extension Study of the Long-term Safety and Efficacy of Rosiglitazone Extended-release (RSG XR) as Adjunctive Therapy to Acetylcholinesterase Inhibitors in Subjects With Mild-to-moderate Alzheimer's Disease (REFLECT-4).

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Incidence and severity of Adverse Events. [ Time Frame: 52 weeks ]

Secondary Outcome Measures:
  • ADAS-cog, CDR-SB, MMSE, DAD and NPI total scores as a function of APOE e4 status. Incidence and severity of SAEs, percentage of subjects with edema, change from baseline in vital signs, weight, non-fasting measures of lipid metabolism. [ Time Frame: 52 weeks ]

Enrollment: 1480
Study Start Date: August 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rosiglitazone XR
Investigational drug
Drug: Rosiglitazone XR
Experimental drug

  Eligibility

Ages Eligible for Study:   51 Years to 91 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Successful completion of AVA102670 or AVA102672 without safety or tolerability issues. Regular caregiver.

Exclusion criteria:

  • Congestive Heart Failure (NYHA 1-4), clinically significant peripheral edema, other neurological conditions that might disqualify participation. SAE, clinically significant laboratory abnormality or significant cardiovascular event during prior study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490568

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Locations
United States, Arizona
GSK Investigational Site
Litchfield Park, Arizona, United States, 85340
GSK Investigational Site
Phoenix, Arizona, United States, 85013
GSK Investigational Site
Tucson, Arizona, United States, 85741
United States, Arkansas
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Little Rock, Arkansas, United States, 72205
United States, California
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Fresno, California, United States, 93720
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Rancho Mirage, California, United States, 92270
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Sacramento, California, United States, 95816
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San Diego, California, United States, 92103
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San Francisco, California, United States, 94109
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Sherman Oaks, California, United States, 91403
United States, Connecticut
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New Haven, Connecticut, United States, 06510
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Norwalk, Connecticut, United States, 06851
United States, Florida
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Deerfield Beach, Florida, United States, 33064
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Delray Beach, Florida, United States, 33445
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Hialeah, Florida, United States, 33016
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Ocala, Florida, United States, 34471
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St. Petersburg, Florida, United States, 33702
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West Palm Beach, Florida, United States, 33407
United States, Indiana
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Fort Wayne, Indiana, United States, 46805
United States, Maryland
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Rockville, Maryland, United States, 20852
United States, Massachusetts
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Springfield, Massachusetts, United States, 01104
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West Yarmouth, Massachusetts, United States, 02673
United States, Minnesota
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St. Paul, Minnesota, United States, 55101
United States, New Jersey
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Morristown, New Jersey, United States, 07960
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Stratford, New Jersey, United States, 08084
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Toms River, New Jersey, United States, 08755
United States, New York
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Albany, New York, United States, 12205
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Brooklyn, New York, United States, 11235
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New York, New York, United States, 10016
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Syracuse, New York, United States, 13210
United States, North Carolina
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Raleigh, North Carolina, United States, 27607
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Winston-Salem, North Carolina, United States, 27103
United States, Ohio
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Columbus, Ohio, United States, 43210
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Toledo, Ohio, United States, 43623
United States, Oklahoma
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Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
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Providence, Rhode Island, United States, 02906
United States, Texas
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Austin, Texas, United States, 78757
United States, Utah
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South Ogden, Utah, United States, 84403
United States, Vermont
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Bennington, Vermont, United States, 05201
United States, Wisconsin
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Milwaukee, Wisconsin, United States, 53226
Argentina
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1192AAW
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1419HDN
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Ciudad de Buenos Aires, Buenos Aires, Argentina, C1431FWO
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Cordoba, Córdova, Argentina, 5000
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Córdoba, Córdova, Argentina, X5004AOA
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Córdoba, Córdova, Argentina, x5009bin
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Godoy Cruz, Mendoza, Argentina, M5504FMI
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Ciudad Autonoma de Buenos Aires, Argentina, C1425CDC
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Mendoza, Argentina, CPM5500HIF
Australia, New South Wales
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Hornsby, New South Wales, Australia, 2077
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Randwick, New South Wales, Australia, 2031
Australia, Queensland
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Auchenflower, Queensland, Australia, 4066
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Chermside, Queensland, Australia, 4032
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Kippa Ring, Queensland, Australia, 4021
Australia, South Australia
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Woodville, South Australia, Australia, 5011
Australia, Victoria
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Cheltenham, Victoria, Australia, 3192
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Heidelberg Heights, Victoria, Australia, 3084
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Kew, Victoria, Australia, 3101
Australia, Western Australia
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Nedlands, Western Australia, Australia, 6009
Austria
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Hall in Tirol, Austria, A-6060
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Vienna, Austria, 1010
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Vienna, Austria, 1030
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Vienna, Austria, A-1130
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Vienna, Austria, A-1220
Belgium
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Kortrijk, Belgium, 8500
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Leuven, Belgium, 3000
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Woluwe-Saint-Lambert, Belgium, 1200
Bulgaria
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Sofia, Bulgaria, 1113
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Sofia, Bulgaria, 1431
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Sofia, Bulgaria, 1527
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Varna, Bulgaria, 9010
Canada, New Brunswick
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Saint John, New Brunswick, Canada, E2L 3L6
Canada, Nova Scotia
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Kentville, Nova Scotia, Canada, B4N 4K9
Canada, Ontario
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Kingston, Ontario, Canada, K7L 4X3
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Kingston, Ontario, Canada, K7L 5G2
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Ottawa, Ontario, Canada, K1G 4G3
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Ottawa, Ontario, Canada, K1N 5C8
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Peterborough, Ontario, Canada, K9H 2P4
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Toronto, Ontario, Canada, M3B 2S7
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Toronto, Ontario, Canada, M5T 2S8
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Toronto, Ontario, Canada, M6M 3Z5
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Whitby, Ontario, Canada, L1N 5S9
Canada, Prince Edward Island
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Charlottetown, Prince Edward Island, Canada, C1A 5Y8
Canada, Quebec
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Greenfield Park, Quebec, Canada, J4V 2J2
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Montreal, Quebec, Canada, H1T 2M4
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Montreal, Quebec, Canada, H4H 1R3
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Québec, Quebec, Canada, G1R 3X5
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Sherbrooke, Quebec, Canada, J1H 1Z1
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Sherbrooke, Quebec, Canada, J1J 3H5
Canada, Saskatchewan
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Regina, Saskatchewan, Canada, S4T 1A5
Chile
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Providencia / Santiago, Región Metro De Santiago, Chile, 7500710
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Santiago, Región Metro De Santiago, Chile, 7560356
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Viña del Mar, Valparaíso, Chile, 252-0997
Czech Republic
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Olomouc, Czech Republic, 775 20
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Ostrava, Czech Republic, 702 00
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Praha 10, Czech Republic, 10000
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Praha 2, Czech Republic, 120 00
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Praha 5, Czech Republic, 150 18
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Praha 7, Czech Republic, 170 00
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Praha 8, Czech Republic, 180 00
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Trutnov, Czech Republic, 541 01
Finland
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Helsinki, Finland, 00120
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Kuopio, Finland, 70211
France
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Bourg en Bresse, France, 01012
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Caen, France, 14033
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Dijon, France, 21000
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Ivry, France, 94206
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La Seyne sur Mer, France, 83500
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Lille, France, 59000
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Limoges, France, 87042
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Luynes, France, 37230
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Lyon, France, 69006
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Marseille, France, 13008
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Marseille, France, 13009
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Metz, France, 57038
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Nantes, France, 44000
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Nantes, France, 44093
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Nantes, France, 44200
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Nantes, France, 44300
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Nice, France, 06002
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Paris, France, 75013
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Pau, France, 64000
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Rodez, France, 12000
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Saint Ouen la Rouerie, France, 35460
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Saint-Etienne, France, 42100
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Sautron, France, 44880
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Tinteniac, France, 35190
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Toulon, France, 83000
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Toulouse, France, 31300
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Tours, France, 37100
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Vichy, France, 03200
Germany
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Aalen, Baden-Wuerttemberg, Germany, 73430
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Ellwangen, Baden-Wuerttemberg, Germany, 73479
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Ludwigsburg, Baden-Wuerttemberg, Germany, 71634
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Ostfildern, Baden-Wuerttemberg, Germany, 73760
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Stuttgart, Baden-Wuerttemberg, Germany, 70176
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Tuebingen, Baden-Wuerttemberg, Germany, 72076
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Ulm, Baden-Wuerttemberg, Germany, 89075
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Alzenau, Bayern, Germany, 63755
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Muenchen, Bayern, Germany, 80331
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Muenchen, Bayern, Germany, 80333
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Muenchen, Bayern, Germany, 81667
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Muenchen, Bayern, Germany, 81675
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Nuernberg, Bayern, Germany, 90402
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Regensburg, Bayern, Germany, 93053
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Unterhaching, Bayern, Germany, 82008
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Bad Saarow, Brandenburg, Germany, 15526
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Bad Homburg, Hessen, Germany, 61348
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Erbach, Hessen, Germany, 64711
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19053
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Achim, Niedersachsen, Germany, 28832
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Bockhorn, Niedersachsen, Germany, 26345
GSK Investigational Site
Ganderkesee, Niedersachsen, Germany, 27777
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Goettingen, Niedersachsen, Germany, 37075
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Hannover, Niedersachsen, Germany, 30559
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Lueneburg, Niedersachsen, Germany, 21335
GSK Investigational Site
Westerstede, Niedersachsen, Germany, 26655
GSK Investigational Site
Bad Honnef, Nordrhein-Westfalen, Germany, 53604
GSK Investigational Site
Baesweiler, Nordrhein-Westfalen, Germany, 52499
GSK Investigational Site
Bergisch Gladbach, Nordrhein-Westfalen, Germany, 51465
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44791
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44805
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44869
GSK Investigational Site
Dueren, Nordrhein-Westfalen, Germany, 52349
GSK Investigational Site
Duisburg, Nordrhein-Westfalen, Germany, 47051
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45138
GSK Investigational Site
Hattingen, Nordrhein-Westfalen, Germany, 45525
GSK Investigational Site
Juelich, Nordrhein-Westfalen, Germany, 52428
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50767
GSK Investigational Site
Krefeld, Nordrhein-Westfalen, Germany, 47800
GSK Investigational Site
Siegen, Nordrhein-Westfalen, Germany, 57072
GSK Investigational Site
Chemnitz, Sachsen, Germany, 09111
GSK Investigational Site
Dresden, Sachsen, Germany, 01097
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
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Leipzig, Sachsen, Germany, 04107
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Leipzig, Sachsen, Germany, 04157
GSK Investigational Site
Gera, Thueringen, Germany, 07551
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Jena, Thueringen, Germany, 07743
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Berlin, Germany, 12163
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Berlin, Germany, 12167
GSK Investigational Site
Berlin, Germany, 12555
GSK Investigational Site
Berlin, Germany, 13156
GSK Investigational Site
Berlin, Germany, 13357
GSK Investigational Site
Berlin, Germany, 13439
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Hamburg, Germany, 21149
GSK Investigational Site
Hamburg, Germany, 22083
Greece
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Athens, Greece, 115 21
GSK Investigational Site
Athens, Greece, 151 23
GSK Investigational Site
Melissia, Greece, 151 27
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Thessaloniki, Greece, 57010
Hong Kong
GSK Investigational Site
Hong Kong, Hong Kong
GSK Investigational Site
Shatin, Hong Kong
Hungary
GSK Investigational Site
Győr, Hungary, 9024
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Szeged, Hungary, 6725
India
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Hyderabad, India, 500 034
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Nagpur, India, 440010
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New Delhi, India, 110002
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Pune, India, 411004
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Varanasi, India, 221005
Italy
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Chieti Scalo, Abruzzo, Italy, 66013
GSK Investigational Site
Napoli, Campania, Italy, 80131
GSK Investigational Site
San Felice a Cancello Caserta, Campania, Italy, 81027
GSK Investigational Site
Roma, Lazio, Italy, 00148
GSK Investigational Site
Roma, Lazio, Italy, 00163
GSK Investigational Site
Roma, Lazio, Italy, 00186
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Brescia, Lombardia, Italy, 25125
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Milano, Lombardia, Italy, 20122
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Milano, Lombardia, Italy, 20127
GSK Investigational Site
Pavia, Lombardia, Italy, 27100
GSK Investigational Site
Rho, Lombardia, Italy, 20017
GSK Investigational Site
Torrette (AN), Marche, Italy, 60020
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Arezzo, Toscana, Italy, 52100
GSK Investigational Site
Firenze, Toscana, Italy, 50134
GSK Investigational Site
Pisa, Toscana, Italy, 56126
Korea, Republic of
GSK Investigational Site
Seongnam-si,, Korea, Republic of, 463-707
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
GSK Investigational Site
Seoul, Korea, Republic of, 150-713
Mexico
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Monterrey, Nuevo León, Mexico, 64660
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64710
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Mexico, Mexico, 14000
Netherlands
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Alkmaar, Netherlands, 1815 JD
GSK Investigational Site
Blaricum, Netherlands, 1261 AN
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Den Bosch, Netherlands, 5232 JL
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Den Haag, Netherlands, 2545 CH
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Hengelo, Netherlands, 7555 DL
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Hilversum, Netherlands, 1213 XZ
Philippines
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Pasig City, Philippines, 1600
Poland
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Bydgoszcz, Poland, 85-096
GSK Investigational Site
Bydgoszcz, Poland, 85-796
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Katowice, Poland, 40-752
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Mosina, Poland, 62-050
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Poznan, Poland, 61-298
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Sopot, Poland, 81-824
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Warsaw, Poland, 02-097
Portugal
GSK Investigational Site
Coimbra, Portugal, 3000-548
GSK Investigational Site
Lisboa, Portugal, 1649-035
Slovakia
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Bratislava, Slovakia, 811 01
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Bratislava, Slovakia, 811 07
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Bratislava, Slovakia, 825 56
GSK Investigational Site
Kosice, Slovakia, 041 66
Slovenia
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Ljubljana, Slovenia, 1000
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Šempeter, Slovenia, 5290
South Africa
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Loeventstein, South Africa, 7530
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Oakdale, South Africa, 7530
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Richards Bay, South Africa, 3900
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Rosebank, South Africa, 2196
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Somerset West, South Africa, 7130
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Waverley, Bloemfontein, South Africa, 9301
GSK Investigational Site
Willows, X14, Pretoria, South Africa, 0040
Spain
GSK Investigational Site
Barcelona, Spain, 08003
GSK Investigational Site
Barcelona, Spain, 08014
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Barcelona, Spain, 08907
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Burgos, Spain, 09006
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Castellón, Spain, 12004
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Elche (Alicante), Spain, 03202
GSK Investigational Site
Gerona, Spain, 17190
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Madrid, Spain, 28006
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Murcia, Spain, 30120
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Palma de Mallorca, Spain, 07014
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Tarrasa, Barcelona, Spain, 08221
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Valencia, Spain, 46010
Sweden
GSK Investigational Site
Jönköping, Sweden, SE-551 85
GSK Investigational Site
Kalix, Sweden, SE-952 82
GSK Investigational Site
Mölndal, Sweden, SE-431 41
GSK Investigational Site
Sundsvall, Sweden, SE-851 86
GSK Investigational Site
Umeå, Sweden, SE-901 85
United Kingdom
GSK Investigational Site
Blackpool, Lancashire, United Kingdom, FY2 0JH
GSK Investigational Site
Bradford, United Kingdom, BD3 0DQ
GSK Investigational Site
Liverpool, United Kingdom, L9 7LJ
GSK Investigational Site
West of Scotland Science Park, Glasgow, United Kingdom, G20 0XA
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: AVA102675
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: AVA102675
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: AVA102675
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: AVA102675
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: AVA102675
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: AVA102675
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: AVA102675
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00490568     History of Changes
Other Study ID Numbers: AVA102675 
Study First Received: June 21, 2007
Last Updated: September 28, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
cognition
Alzheimer's disease
Rosiglitazone extended-release (XR)
safety
adjunctive therapy
BRL-049653
tolerability
open-label extension

Additional relevant MeSH terms:
Alzheimer Disease
Rosiglitazone
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Hypoglycemic Agents

ClinicalTrials.gov processed this record on December 08, 2016