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

NCT00490568 | Terminated Phase 3 Results

• 1 other identifier: AVA102675
• Study Type: interventional
• Target: 1,461
• Locations: 27 countries
• Sites: 260

Brief Summary

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.

Conditions

Alzheimer's Disease

Keywords

cognition; Alzheimer's disease; Rosiglitazone extended-release (XR); safety; adjunctive therapy; BRL-049653; tolerability; open-label extension

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Any Adverse Events (AEs) and Severity of AEs

  An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The severity of the AE'S was categorized as mild, moderate and severe. Number of participants reporting AEs during the on treatment phase of the study.

  Up to 76 Weeks

Secondary Outcomes (16)

• Number Participants With Serious Adverse Events (SAEs) and Deaths

  Up to 76 Weeks

• Number of Participants With Adverse Event of Oedema

  Up to 76 Weeks

• Change From Baseline in Vital Sign Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

  Up to 70 Weeks (including follow up)

• Change From Baseline in Vital Sign Heart Rate (HR)

  Up to 70 Weeks (including follow up)

• Change From Baseline in Vital Sign Body Weight (BW)

  Up to 70 Weeks (including follow up)

Study Arms (1)

Rosiglitazone XR

EXPERIMENTAL

Investigational drug

Drug: Rosiglitazone XR

Interventions

Rosiglitazone XR DRUG

Experimental drug

Rosiglitazone XR

Eligibility Criteria

• Age: 51 Years - 91 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (272)

GSK Investigational Site

Litchfield Park, Arizona, 85340, United States

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GSK Investigational Site

Phoenix, Arizona, 85013, United States

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GSK Investigational Site

Tucson, Arizona, 85741, United States

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GSK Investigational Site

Little Rock, Arkansas, 72205, United States

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GSK Investigational Site

Fresno, California, 93720, United States

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GSK Investigational Site

Rancho Mirage, California, 92270, United States

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GSK Investigational Site

Sacramento, California, 95816, United States

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GSK Investigational Site

San Diego, California, 92103, United States

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GSK Investigational Site

San Francisco, California, 94109, United States

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GSK Investigational Site

Sherman Oaks, California, 91403, United States

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GSK Investigational Site

New Haven, Connecticut, 06510, United States

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GSK Investigational Site

Norwalk, Connecticut, 06851, United States

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GSK Investigational Site

Deerfield Beach, Florida, 33064, United States

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GSK Investigational Site

Delray Beach, Florida, 33445, United States

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GSK Investigational Site

Hialeah, Florida, 33016, United States

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GSK Investigational Site

Ocala, Florida, 34471, United States

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GSK Investigational Site

St. Petersburg, Florida, 33702, United States

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GSK Investigational Site

West Palm Beach, Florida, 33407, United States

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GSK Investigational Site

Fort Wayne, Indiana, 46805, United States

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Rockville, Maryland, 20852, United States

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Springfield, Massachusetts, 01104, United States

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West Yarmouth, Massachusetts, 02673, United States

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Saint Paul, Minnesota, 55101, United States

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GSK Investigational Site

Morristown, New Jersey, 07960, United States

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GSK Investigational Site

Stratford, New Jersey, 08084, United States

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GSK Investigational Site

Toms River, New Jersey, 08755, United States

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GSK Investigational Site

Albany, New York, 12205, United States

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GSK Investigational Site

Brooklyn, New York, 11235, United States

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GSK Investigational Site

New York, New York, 10016, United States

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GSK Investigational Site

Syracuse, New York, 13210, United States

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Raleigh, North Carolina, 27607, United States

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GSK Investigational Site

Winston-Salem, North Carolina, 27103, United States

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Columbus, Ohio, 43210, United States

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Toledo, Ohio, 43623, United States

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Tulsa, Oklahoma, 74104, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Providence, Rhode Island, 02906, United States

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Austin, Texas, 78757, United States

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South Ogden, Utah, 84403, United States

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Bennington, Vermont, 05201, United States

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Milwaukee, Wisconsin, 53226, United States

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Ciudad Autónoma de Buenos Aires, Buenos Aires, C1192AAW, Argentina

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Ciudad Autónoma de Buenos Aires, Buenos Aires, C1419HDN, Argentina

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Ciudad de Buenos Aires, Buenos Aires, C1431FWO, Argentina

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GSK Investigational Site

Córdoba, Córdoba Province, 5000, Argentina

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GSK Investigational Site

Córdoba, Córdoba Province, X5004AOA, Argentina

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Córdoba, Córdoba Province, x5009bin, Argentina

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Godoy Cruz, Mendoza Province, M5504FMI, Argentina

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Buenos Aires, C1425CDC, Argentina

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GSK Investigational Site

Mendoza, CPM5500HIF, Argentina

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Hornsby, New South Wales, 2077, Australia

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Randwick, New South Wales, 2031, Australia

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GSK Investigational Site

Auchenflower, Queensland, 4066, Australia

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GSK Investigational Site

Chermside, Queensland, 4032, Australia

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GSK Investigational Site

Kippa-Ring, Queensland, 4021, Australia

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GSK Investigational Site

Woodville, South Australia, 5011, Australia

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GSK Investigational Site

Cheltenham, Victoria, 3192, Australia

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GSK Investigational Site

Heidelberg Heights, Victoria, 3084, Australia

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GSK Investigational Site

Kew, Victoria, 3101, Australia

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GSK Investigational Site

Nedlands, Western Australia, 6009, Australia

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GSK Investigational Site

Hall in Tirol, A-6060, Austria

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GSK Investigational Site

Vienna, 1010, Austria

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Vienna, 1030, Austria

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Vienna, A-1130, Austria

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Vienna, A-1220, Austria

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Kortrijk, 8500, Belgium

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Leuven, 3000, Belgium

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Woluwe-Saint-Lambert, 1200, Belgium

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Sofia, 1113, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1527, Bulgaria

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Varna, 9010, Bulgaria

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Saint John, New Brunswick, E2L 3L6, Canada

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Kentville, Nova Scotia, B4N 4K9, Canada

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Kingston, Ontario, K7L 4X3, Canada

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Kingston, Ontario, K7L 5G2, Canada

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Ottawa, Ontario, K1G 4G3, Canada

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Ottawa, Ontario, K1N 5C8, Canada

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Peterborough, Ontario, K9H 2P4, Canada

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Toronto, Ontario, M3B 2S7, Canada

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Toronto, Ontario, M5T 2S8, Canada

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Toronto, Ontario, M6M 3Z5, Canada

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Whitby, Ontario, L1N 5S9, Canada

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Charlottetown, Prince Edward Island, C1A 5Y8, Canada

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Greenfield Park, Quebec, J4V 2J2, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Montreal, Quebec, H4H 1R3, Canada

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Sherbrooke, Quebec, J1H 1Z1, Canada

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Sherbrooke, Quebec, J1J 3H5, Canada

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GSK Investigational Site

Regina, Saskatchewan, S4T 1A5, Canada

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Québec, G1R 3X5, Canada

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GSK Investigational Site

Viña del Mar, Región de Valparaíso, 252-0997, Chile

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GSK Investigational Site

Providencia / Santiago, Región Metro de Santiago, 7500710, Chile

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GSK Investigational Site

Santiago, Región Metro de Santiago, 7560356, Chile

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GSK Investigational Site

Olomouc, 775 20, Czechia

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GSK Investigational Site

Ostrava, 702 00, Czechia

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Prague, 10000, Czechia

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GSK Investigational Site

Prague, 120 00, Czechia

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Prague, 150 18, Czechia

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GSK Investigational Site

Prague, 170 00, Czechia

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Prague, 180 00, Czechia

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GSK Investigational Site

Trutnov, 541 01, Czechia

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GSK Investigational Site

Helsinki, 00120, Finland

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GSK Investigational Site

Kuopio, 70211, Finland

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GSK Investigational Site

Bourg-en-Bresse, 01012, France

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GSK Investigational Site

Caen, 14033, France

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GSK Investigational Site

Dijon, 21000, France

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GSK Investigational Site

Ivry, 94206, France

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GSK Investigational Site

La Seyne-sur-Mer, 83500, France

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GSK Investigational Site

Lille, 59000, France

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GSK Investigational Site

Limoges, 87042, France

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GSK Investigational Site

Luynes, 37230, France

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GSK Investigational Site

Lyon, 69006, France

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GSK Investigational Site

Marseille, 13008, France

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GSK Investigational Site

Marseille, 13009, France

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GSK Investigational Site

Metz, 57038, France

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GSK Investigational Site

Nantes, 44000, France

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GSK Investigational Site

Nantes, 44093, France

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GSK Investigational Site

Nantes, 44200, France

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GSK Investigational Site

Nantes, 44300, France

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GSK Investigational Site

Nice, 06002, France

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GSK Investigational Site

Paris, 75013, France

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GSK Investigational Site

Pau, 64000, France

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Rodez, 12000, France

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GSK Investigational Site

Saint-Etienne, 42100, France

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GSK Investigational Site

Saint-Ouen-la-Rouërie, 35460, France

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GSK Investigational Site

Sautron, 44880, France

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GSK Investigational Site

Tinténiac, 35190, France

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GSK Investigational Site

Toulon, 83000, France

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GSK Investigational Site

Toulouse, 31300, France

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GSK Investigational Site

Tours, 37100, France

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GSK Investigational Site

Vichy, 03200, France

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GSK Investigational Site

Aalen, Baden-Wurttemberg, 73430, Germany

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GSK Investigational Site

Ellwangen, Baden-Wurttemberg, 73479, Germany

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GSK Investigational Site

Ludwigsburg, Baden-Wurttemberg, 71634, Germany

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GSK Investigational Site

Ostfildern, Baden-Wurttemberg, 73760, Germany

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GSK Investigational Site

Stuttgart, Baden-Wurttemberg, 70176, Germany

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GSK Investigational Site

Tübingen, Baden-Wurttemberg, 72076, Germany

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GSK Investigational Site

Ulm, Baden-Wurttemberg, 89075, Germany

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GSK Investigational Site

Alzenau in Unterfranken, Bavaria, 63755, Germany

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GSK Investigational Site

Munich, Bavaria, 80331, Germany

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GSK Investigational Site

Munich, Bavaria, 80333, Germany

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GSK Investigational Site

Munich, Bavaria, 81667, Germany

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GSK Investigational Site

Munich, Bavaria, 81675, Germany

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GSK Investigational Site

Nuremberg, Bavaria, 90402, Germany

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GSK Investigational Site

Regensburg, Bavaria, 93053, Germany

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GSK Investigational Site

Unterhaching, Bavaria, 82008, Germany

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GSK Investigational Site

Bad Saarow, Brandenburg, 15526, Germany

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GSK Investigational Site

Bad Homburg, Hesse, 61348, Germany

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GSK Investigational Site

Erbach im Odenwald, Hesse, 64711, Germany

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GSK Investigational Site

Achim, Lower Saxony, 28832, Germany

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GSK Investigational Site

Bockhorn, Lower Saxony, 26345, Germany

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GSK Investigational Site

Ganderkesee, Lower Saxony, 27777, Germany

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GSK Investigational Site

Göttingen, Lower Saxony, 37075, Germany

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GSK Investigational Site

Hanover, Lower Saxony, 30559, Germany

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Lüneburg, Lower Saxony, 21335, Germany

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GSK Investigational Site

Westerstede, Lower Saxony, 26655, Germany

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GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, 19053, Germany

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GSK Investigational Site

Bad Honnef, North Rhine-Westphalia, 53604, Germany

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Baesweiler, North Rhine-Westphalia, 52499, Germany

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Bergisch Gladbach, North Rhine-Westphalia, 51465, Germany

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GSK Investigational Site

Bochum, North Rhine-Westphalia, 44791, Germany

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GSK Investigational Site

Bochum, North Rhine-Westphalia, 44805, Germany

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Bochum, North Rhine-Westphalia, 44869, Germany

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Cologne, North Rhine-Westphalia, 50767, Germany

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Duisburg, North Rhine-Westphalia, 47051, Germany

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Düren, North Rhine-Westphalia, 52349, Germany

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Essen, North Rhine-Westphalia, 45138, Germany

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Hattingen, North Rhine-Westphalia, 45525, Germany

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GSK Investigational Site

Jülich, North Rhine-Westphalia, 52428, Germany

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Krefeld, North Rhine-Westphalia, 47800, Germany

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GSK Investigational Site

Siegen, North Rhine-Westphalia, 57072, Germany

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GSK Investigational Site

Chemnitz, Saxony, 09111, Germany

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GSK Investigational Site

Dresden, Saxony, 01097, Germany

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Dresden, Saxony, 01307, Germany

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GSK Investigational Site

Leipzig, Saxony, 04107, Germany

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GSK Investigational Site

Leipzig, Saxony, 04157, Germany

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GSK Investigational Site

Gera, Thuringia, 07551, Germany

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GSK Investigational Site

Jena, Thuringia, 07743, Germany

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Berlin, 12163, Germany

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Berlin, 12167, Germany

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Berlin, 12555, Germany

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Berlin, 13156, Germany

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Berlin, 13357, Germany

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GSK Investigational Site

Berlin, 13439, Germany

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GSK Investigational Site

Hamburg, 21149, Germany

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GSK Investigational Site

Hamburg, 22083, Germany

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GSK Investigational Site

Athens, 115 21, Greece

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GSK Investigational Site

Athens, 151 23, Greece

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GSK Investigational Site

Melíssia, 151 27, Greece

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GSK Investigational Site

Thessaloniki, 57010, Greece

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GSK Investigational Site

Hong Kong, Hong Kong

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GSK Investigational Site

Shatin, Hong Kong

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GSK Investigational Site

Győr, 9024, Hungary

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GSK Investigational Site

Szeged, 6725, Hungary

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GSK Investigational Site

Hyderabad, 500 034, India

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GSK Investigational Site

Nagpur, 440010, India

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GSK Investigational Site

New Delhi, 110002, India

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Pune, 411004, India

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GSK Investigational Site

Varanasi, 221005, India

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Chieti Scalo, Abruzzo, 66013, Italy

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Napoli, Campania, 80131, Italy

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San Felice A Cancello Caserta, Campania, 81027, Italy

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Rome, Lazio, 00148, Italy

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GSK Investigational Site

Rome, Lazio, 00163, Italy

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Rome, Lazio, 00186, Italy

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Brescia, Lombardy, 25125, Italy

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GSK Investigational Site

Milan, Lombardy, 20122, Italy

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GSK Investigational Site

Milan, Lombardy, 20127, Italy

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GSK Investigational Site

Pavia, Lombardy, 27100, Italy

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Rho, Lombardy, 20017, Italy

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Torrette (AN), The Marches, 60020, Italy

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GSK Investigational Site

Arezzo, Tuscany, 52100, Italy

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Florence, Tuscany, 50134, Italy

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GSK Investigational Site

Pisa, Tuscany, 56126, Italy

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Monterrey, Nuevo León, 64660, Mexico

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GSK Investigational Site

Monterrey, Nuevo León, 64710, Mexico

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GSK Investigational Site

México, 14000, Mexico

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's-Hertogenbosch, 5232 JL, Netherlands

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Alkmaar, 1815 JD, Netherlands

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Blaricum, 1261 AN, Netherlands

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Hengelo, 7555 DL, Netherlands

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GSK Investigational Site

Hilversum, 1213 XZ, Netherlands

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The Hague, 2545 CH, Netherlands

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GSK Investigational Site

Pasig, 1600, Philippines

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Bydgoszcz, 85-096, Poland

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Bydgoszcz, 85-796, Poland

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Katowice, 40-752, Poland

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Mosina, 62-050, Poland

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Poznan, 61-298, Poland

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Sopot, 81-824, Poland

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Warsaw, 02-097, Poland

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Coimbra, 3000-548, Portugal

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Lisbon, 1649-035, Portugal

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Bratislava, 811 01, Slovakia

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Bratislava, 811 07, Slovakia

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Bratislava, 825 56, Slovakia

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Košice, 041 66, Slovakia

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Ljubljana, 1000, Slovenia

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GSK Investigational Site

Šempeter v Savinj. Dolini, 5290, Slovenia

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Loeventstein, 7530, South Africa

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Oakdale, 7530, South Africa

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Richards Bay, 3900, South Africa

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Rosebank, 2196, South Africa

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Somerset West, 7130, South Africa

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Waverley, Bloemfontein, 9301, South Africa

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Willows, X14, Pretoria, 0040, South Africa

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GSK Investigational Site

Seongnam-si, 463-707, South Korea

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GSK Investigational Site

Seoul, 138-736, South Korea

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GSK Investigational Site

Seoul, 150-713, South Korea

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GSK Investigational Site

Barcelona, 08003, Spain

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GSK Investigational Site

Barcelona, 08014, Spain

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GSK Investigational Site

Barcelona, 08036, Spain

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GSK Investigational Site

Barcelona, 08907, Spain

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GSK Investigational Site

Burgos, 09006, Spain

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GSK Investigational Site

Castellon, 12004, Spain

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GSK Investigational Site

Elche (Alicante), 03202, Spain

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GSK Investigational Site

Girona, 17190, Spain

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GSK Investigational Site

Madrid, 28006, Spain

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GSK Investigational Site

Murcia, 30120, Spain

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GSK Investigational Site

Palma de Mallorca, 07014, Spain

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GSK Investigational Site

Tarrasa, Barcelona, 08221, Spain

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GSK Investigational Site

Valencia, 46010, Spain

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GSK Investigational Site

Jönköping, SE-551 85, Sweden

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GSK Investigational Site

Kalix, SE-952 82, Sweden

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GSK Investigational Site

Mölndal, SE-431 41, Sweden

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GSK Investigational Site

Sundsvall, SE-851 86, Sweden

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GSK Investigational Site

Umeå, SE-901 85, Sweden

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GSK Investigational Site

Blackpool, Lancashire, FY2 0JH, United Kingdom

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GSK Investigational Site

Bradford, BD3 0DQ, United Kingdom

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Liverpool, L9 7LJ, United Kingdom

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GSK Investigational Site

West of Scotland Science Park, Glasgow, G20 0XA, United Kingdom

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Related Publications (1)

• Harrington C, Sawchak S, Chiang C, Davies J, Donovan C, Saunders AM, Irizarry M, Jeter B, Zvartau-Hind M, van Dyck CH, Gold M. Rosiglitazone does not improve cognition or global function when used as adjunctive therapy to AChE inhibitors in mild-to-moderate Alzheimer's disease: two phase 3 studies. Curr Alzheimer Res. 2011 Aug;8(5):592-606. doi: 10.2174/156720511796391935.

  PMID: 21592048 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2007
• First Posted: June 22, 2007
• Study Start: August 8, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: November 13, 2017
• Results First Posted: November 13, 2017

Record last verified: 2017-09

Locations

GB (4); KR (3); BU (4); HK (2); AR (9); AU (5); PT (2); ME (3); CA (19); GR (4); PH (1); SL (4); BE (3); US (41); HU (2); IT (15); FI (2); IN (5); SE (5); FR (28); NL (6); ES (13); ZA (7); PL (7); CZ (8); DE (55); CL (3)