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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00490568




Registration number
NCT00490568
Ethics application status
Date submitted
21/06/2007
Date registered
22/06/2007
Date last updated
13/11/2017

Titles & IDs
Public title
Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers
Scientific title
An Open-label Extension to Study AVA102670 and AVA102672, to Assess the Long-term Safety and Efficacy of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy on Cognition in Subjects With Mild to Moderate Alzheimer's Disease.
Secondary ID [1] 0 0
AVA102675
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rosiglitazone XR

Experimental: Rosiglitazone XR - Investigational drug


Treatment: Drugs: Rosiglitazone XR
Experimental drug
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Any Adverse Events (AEs) and Severity of AEs
Timepoint [1] 0 0
Up to 76 Weeks
Secondary outcome [1] 0 0
Number Participants With Serious Adverse Events (SAEs) and Deaths
Timepoint [1] 0 0
Up to 76 Weeks
Secondary outcome [2] 0 0
Number of Participants With Adverse Event of Oedema
Timepoint [2] 0 0
Up to 76 Weeks
Secondary outcome [3] 0 0
Change From Baseline in Vital Sign Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Timepoint [3] 0 0
Up to 70 Weeks (including follow up)
Secondary outcome [4] 0 0
Change From Baseline in Vital Sign Heart Rate (HR)
Timepoint [4] 0 0
Up to 70 Weeks (including follow up)
Secondary outcome [5] 0 0
Change From Baseline in Vital Sign Body Weight (BW)
Timepoint [5] 0 0
Up to 70 Weeks (including follow up)
Secondary outcome [6] 0 0
Change From Baseline in Non-fasting Measures of Lipid Metabolism Namely Total Cholesterol (TC), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides
Timepoint [6] 0 0
Up to 82 Weeks (including follow up)
Secondary outcome [7] 0 0
Number of Participants With SBP and DBP Values of Potential Clinical Concern (PCC)
Timepoint [7] 0 0
Up to 70 Weeks (including follow up)
Secondary outcome [8] 0 0
Number of Participants With HR Values of PCC ATOT
Timepoint [8] 0 0
Up to 70 Weeks (including follow up)
Secondary outcome [9] 0 0
Number of Participants With BW Values of PCC ATOT
Timepoint [9] 0 0
Up to 70 Weeks (including follow up)
Secondary outcome [10] 0 0
Number of Participants With Hematology Parameters of PCC ATOT
Timepoint [10] 0 0
Up to Week 82 (including follow up)
Secondary outcome [11] 0 0
Number of Participants With Clinical Chemistry Parameters (Including Lipids) of PCC ATOT
Timepoint [11] 0 0
Up to Week 82 (including follow up)
Secondary outcome [12] 0 0
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Total Score as a Function of Apolipoprotein E (APOE) e4 Status.
Timepoint [12] 0 0
Baseline (Week 0) and Week 24, 52
Secondary outcome [13] 0 0
Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score as a Function of APOE e4 Status.
Timepoint [13] 0 0
Baseline (Week 0) and Week 24, 52
Secondary outcome [14] 0 0
Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE e4 Status.
Timepoint [14] 0 0
Baseline (Week 0) and Week 24, 52
Secondary outcome [15] 0 0
Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOE e4 Status.
Timepoint [15] 0 0
Baseline (Week 0) and Week 24, 52
Secondary outcome [16] 0 0
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE e4 Status.
Timepoint [16] 0 0
Baseline (Week 0) and Week 24, 52

Eligibility
Key inclusion criteria
Inclusion criteria:

* Successful completion of AVA102670 or AVA102672 without safety or tolerability issues. Regular caregiver.
Minimum age
51 Years
Maximum age
91 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/08/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2009
Sample size
Target
Accrual to date
Final
1461
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Hornsby
Recruitment hospital [2] 0 0
GSK Investigational Site - Randwick
Recruitment hospital [3] 0 0
GSK Investigational Site - Auchenflower
Recruitment hospital [4] 0 0
GSK Investigational Site - Chermside
Recruitment hospital [5] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [6] 0 0
GSK Investigational Site - Woodville
Recruitment hospital [7] 0 0
GSK Investigational Site - Cheltenham
Recruitment hospital [8] 0 0
GSK Investigational Site - Heidelberg Heights
Recruitment hospital [9] 0 0
GSK Investigational Site - Kew
Recruitment hospital [10] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2077 - Hornsby
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
4032 - Chermside
Recruitment postcode(s) [5] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [6] 0 0
5011 - Woodville
Recruitment postcode(s) [7] 0 0
3192 - Cheltenham
Recruitment postcode(s) [8] 0 0
3084 - Heidelberg Heights
Recruitment postcode(s) [9] 0 0
3101 - Kew
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Rhode Island
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
United States of America
State/province [19] 0 0
Vermont
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Córdova
Country [23] 0 0
Argentina
State/province [23] 0 0
Mendoza
Country [24] 0 0
Argentina
State/province [24] 0 0
Ciudad Autonoma de Buenos Aires
Country [25] 0 0
Austria
State/province [25] 0 0
Hall in Tirol
Country [26] 0 0
Austria
State/province [26] 0 0
Vienna
Country [27] 0 0
Belgium
State/province [27] 0 0
Kortrijk
Country [28] 0 0
Belgium
State/province [28] 0 0
Leuven
Country [29] 0 0
Belgium
State/province [29] 0 0
Woluwe-Saint-Lambert
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Sofia
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Varna
Country [32] 0 0
Canada
State/province [32] 0 0
New Brunswick
Country [33] 0 0
Canada
State/province [33] 0 0
Nova Scotia
Country [34] 0 0
Canada
State/province [34] 0 0
Ontario
Country [35] 0 0
Canada
State/province [35] 0 0
Prince Edward Island
Country [36] 0 0
Canada
State/province [36] 0 0
Quebec
Country [37] 0 0
Canada
State/province [37] 0 0
Saskatchewan
Country [38] 0 0
Canada
State/province [38] 0 0
Québec
Country [39] 0 0
Chile
State/province [39] 0 0
Región Metro De Santiago
Country [40] 0 0
Chile
State/province [40] 0 0
Valparaíso
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Czechia
State/province [41] 0 0
Olomouc
Country [42] 0 0
Czechia
State/province [42] 0 0
Ostrava
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Czechia
State/province [43] 0 0
Praha 10
Country [44] 0 0
Czechia
State/province [44] 0 0
Praha 2
Country [45] 0 0
Czechia
State/province [45] 0 0
Praha 5
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Czechia
State/province [46] 0 0
Praha 7
Country [47] 0 0
Czechia
State/province [47] 0 0
Praha 8
Country [48] 0 0
Czechia
State/province [48] 0 0
Trutnov
Country [49] 0 0
Finland
State/province [49] 0 0
Helsinki
Country [50] 0 0
Finland
State/province [50] 0 0
Kuopio
Country [51] 0 0
France
State/province [51] 0 0
Bourg en Bresse
Country [52] 0 0
France
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Caen
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France
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Dijon
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France
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Ivry
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France
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La Seyne sur Mer
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France
State/province [56] 0 0
Lille
Country [57] 0 0
France
State/province [57] 0 0
Limoges
Country [58] 0 0
France
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Luynes
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France
State/province [59] 0 0
Lyon
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France
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Marseille
Country [61] 0 0
France
State/province [61] 0 0
Metz
Country [62] 0 0
France
State/province [62] 0 0
Nantes
Country [63] 0 0
France
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Nice
Country [64] 0 0
France
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Paris
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Pau
Country [66] 0 0
France
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Rodez
Country [67] 0 0
France
State/province [67] 0 0
Saint Ouen la Rouerie
Country [68] 0 0
France
State/province [68] 0 0
Saint-Etienne
Country [69] 0 0
France
State/province [69] 0 0
Sautron
Country [70] 0 0
France
State/province [70] 0 0
Tinteniac
Country [71] 0 0
France
State/province [71] 0 0
Toulon
Country [72] 0 0
France
State/province [72] 0 0
Toulouse
Country [73] 0 0
France
State/province [73] 0 0
Tours
Country [74] 0 0
France
State/province [74] 0 0
Vichy
Country [75] 0 0
Germany
State/province [75] 0 0
Baden-Wuerttemberg
Country [76] 0 0
Germany
State/province [76] 0 0
Bayern
Country [77] 0 0
Germany
State/province [77] 0 0
Brandenburg
Country [78] 0 0
Germany
State/province [78] 0 0
Hessen
Country [79] 0 0
Germany
State/province [79] 0 0
Mecklenburg-Vorpommern
Country [80] 0 0
Germany
State/province [80] 0 0
Niedersachsen
Country [81] 0 0
Germany
State/province [81] 0 0
Nordrhein-Westfalen
Country [82] 0 0
Germany
State/province [82] 0 0
Sachsen
Country [83] 0 0
Germany
State/province [83] 0 0
Thueringen
Country [84] 0 0
Germany
State/province [84] 0 0
Berlin
Country [85] 0 0
Germany
State/province [85] 0 0
Hamburg
Country [86] 0 0
Greece
State/province [86] 0 0
Athens
Country [87] 0 0
Greece
State/province [87] 0 0
Melissia
Country [88] 0 0
Greece
State/province [88] 0 0
Thessaloniki
Country [89] 0 0
Hong Kong
State/province [89] 0 0
Hong Kong
Country [90] 0 0
Hong Kong
State/province [90] 0 0
Shatin
Country [91] 0 0
Hungary
State/province [91] 0 0
Gyor
Country [92] 0 0
Hungary
State/province [92] 0 0
Szeged
Country [93] 0 0
India
State/province [93] 0 0
Hyderabad
Country [94] 0 0
India
State/province [94] 0 0
Nagpur
Country [95] 0 0
India
State/province [95] 0 0
New Delhi
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India
State/province [96] 0 0
Pune
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India
State/province [97] 0 0
Varanasi
Country [98] 0 0
Italy
State/province [98] 0 0
Abruzzo
Country [99] 0 0
Italy
State/province [99] 0 0
Campania
Country [100] 0 0
Italy
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Lazio
Country [101] 0 0
Italy
State/province [101] 0 0
Lombardia
Country [102] 0 0
Italy
State/province [102] 0 0
Marche
Country [103] 0 0
Italy
State/province [103] 0 0
Toscana
Country [104] 0 0
Korea, Republic of
State/province [104] 0 0
Seongnam-si,
Country [105] 0 0
Korea, Republic of
State/province [105] 0 0
Seoul
Country [106] 0 0
Mexico
State/province [106] 0 0
Nuevo León
Country [107] 0 0
Mexico
State/province [107] 0 0
Mexico
Country [108] 0 0
Netherlands
State/province [108] 0 0
Alkmaar
Country [109] 0 0
Netherlands
State/province [109] 0 0
Blaricum
Country [110] 0 0
Netherlands
State/province [110] 0 0
Den Bosch
Country [111] 0 0
Netherlands
State/province [111] 0 0
Den Haag
Country [112] 0 0
Netherlands
State/province [112] 0 0
Hengelo
Country [113] 0 0
Netherlands
State/province [113] 0 0
Hilversum
Country [114] 0 0
Philippines
State/province [114] 0 0
Pasig City
Country [115] 0 0
Poland
State/province [115] 0 0
Bydgoszcz
Country [116] 0 0
Poland
State/province [116] 0 0
Katowice
Country [117] 0 0
Poland
State/province [117] 0 0
Mosina
Country [118] 0 0
Poland
State/province [118] 0 0
Poznan
Country [119] 0 0
Poland
State/province [119] 0 0
Sopot
Country [120] 0 0
Poland
State/province [120] 0 0
Warsaw
Country [121] 0 0
Portugal
State/province [121] 0 0
Coimbra
Country [122] 0 0
Portugal
State/province [122] 0 0
Lisboa
Country [123] 0 0
Slovakia
State/province [123] 0 0
Bratislava
Country [124] 0 0
Slovakia
State/province [124] 0 0
Kosice
Country [125] 0 0
Slovenia
State/province [125] 0 0
Ljubljana
Country [126] 0 0
Slovenia
State/province [126] 0 0
Šempeter
Country [127] 0 0
South Africa
State/province [127] 0 0
Loeventstein
Country [128] 0 0
South Africa
State/province [128] 0 0
Oakdale
Country [129] 0 0
South Africa
State/province [129] 0 0
Richards Bay
Country [130] 0 0
South Africa
State/province [130] 0 0
Rosebank
Country [131] 0 0
South Africa
State/province [131] 0 0
Somerset West
Country [132] 0 0
South Africa
State/province [132] 0 0
Waverley, Bloemfontein
Country [133] 0 0
South Africa
State/province [133] 0 0
Willows, X14, Pretoria
Country [134] 0 0
Spain
State/province [134] 0 0
Barcelona
Country [135] 0 0
Spain
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Burgos
Country [136] 0 0
Spain
State/province [136] 0 0
Castellón
Country [137] 0 0
Spain
State/province [137] 0 0
Elche (Alicante)
Country [138] 0 0
Spain
State/province [138] 0 0
Gerona
Country [139] 0 0
Spain
State/province [139] 0 0
Madrid
Country [140] 0 0
Spain
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Murcia
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Spain
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Palma de Mallorca
Country [142] 0 0
Spain
State/province [142] 0 0
Tarrasa, Barcelona
Country [143] 0 0
Spain
State/province [143] 0 0
Valencia
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Sweden
State/province [144] 0 0
Jönköping
Country [145] 0 0
Sweden
State/province [145] 0 0
Kalix
Country [146] 0 0
Sweden
State/province [146] 0 0
Mölndal
Country [147] 0 0
Sweden
State/province [147] 0 0
Sundsvall
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Sweden
State/province [148] 0 0
Umeå
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Lancashire
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Bradford
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Liverpool
Country [152] 0 0
United Kingdom
State/province [152] 0 0
West of Scotland Science Park, Glasgow

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00490568