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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
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Castellón
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Gerona
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Murcia
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Tarrasa, Barcelona
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Valencia
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Sundsvall
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Lancashire
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Bradford
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Liverpool
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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
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.
Trial website
https://clinicaltrials.gov/study/NCT00490568
Trial related presentations / publications
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.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00490568