MedDataX Logo

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

NCT ID: NCT00490568

Last Updated: 2017-11-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1461 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-08

Study Completion Date

2009-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer's Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rosiglitazone XR

Investigational drug

Group Type EXPERIMENTAL

Rosiglitazone XR

Intervention Type DRUG

Experimental drug

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rosiglitazone XR

Experimental drug

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

51 Years

Maximum Eligible Age

91 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Litchfield Park, Arizona, United States

Site Status

GSK Investigational Site

Phoenix, Arizona, United States

Site Status

GSK Investigational Site

Tucson, Arizona, United States

Site Status

GSK Investigational Site

Little Rock, Arkansas, United States

Site Status

GSK Investigational Site

Fresno, California, United States

Site Status

GSK Investigational Site

Rancho Mirage, California, United States

Site Status

GSK Investigational Site

Sacramento, California, United States

Site Status

GSK Investigational Site

San Diego, California, United States

Site Status

GSK Investigational Site

San Francisco, California, United States

Site Status

GSK Investigational Site

Sherman Oaks, California, United States

Site Status

GSK Investigational Site

New Haven, Connecticut, United States

Site Status

GSK Investigational Site

Norwalk, Connecticut, United States

Site Status

GSK Investigational Site

Deerfield Beach, Florida, United States

Site Status

GSK Investigational Site

Delray Beach, Florida, United States

Site Status

GSK Investigational Site

Hialeah, Florida, United States

Site Status

GSK Investigational Site

Ocala, Florida, United States

Site Status

GSK Investigational Site

St. Petersburg, Florida, United States

Site Status

GSK Investigational Site

West Palm Beach, Florida, United States

Site Status

GSK Investigational Site

Fort Wayne, Indiana, United States

Site Status

GSK Investigational Site

Rockville, Maryland, United States

Site Status

GSK Investigational Site

Springfield, Massachusetts, United States

Site Status

GSK Investigational Site

West Yarmouth, Massachusetts, United States

Site Status

GSK Investigational Site

Saint Paul, Minnesota, United States

Site Status

GSK Investigational Site

Morristown, New Jersey, United States

Site Status

GSK Investigational Site

Stratford, New Jersey, United States

Site Status

GSK Investigational Site

Toms River, New Jersey, United States

Site Status

GSK Investigational Site

Albany, New York, United States

Site Status

GSK Investigational Site

Brooklyn, New York, United States

Site Status

GSK Investigational Site

New York, New York, United States

Site Status

GSK Investigational Site

Syracuse, New York, United States

Site Status

GSK Investigational Site

Raleigh, North Carolina, United States

Site Status

GSK Investigational Site

Winston-Salem, North Carolina, United States

Site Status

GSK Investigational Site

Columbus, Ohio, United States

Site Status

GSK Investigational Site

Toledo, Ohio, United States

Site Status

GSK Investigational Site

Tulsa, Oklahoma, United States

Site Status

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

GSK Investigational Site

Providence, Rhode Island, United States

Site Status

GSK Investigational Site

Austin, Texas, United States

Site Status

GSK Investigational Site

South Ogden, Utah, United States

Site Status

GSK Investigational Site

Bennington, Vermont, United States

Site Status

GSK Investigational Site

Milwaukee, Wisconsin, United States

Site Status

GSK Investigational Site

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site Status

GSK Investigational Site

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site Status

GSK Investigational Site

Ciudad de Buenos Aires, Buenos Aires, Argentina

Site Status

GSK Investigational Site

Córdoba, Córdoba Province, Argentina

Site Status

GSK Investigational Site

Córdoba, Córdoba Province, Argentina

Site Status

GSK Investigational Site

Córdoba, Córdoba Province, Argentina

Site Status

GSK Investigational Site

Godoy Cruz, Mendoza Province, Argentina

Site Status

GSK Investigational Site

Buenos Aires, , Argentina

Site Status

GSK Investigational Site

Mendoza, , Argentina

Site Status

GSK Investigational Site

Hornsby, New South Wales, Australia

Site Status

GSK Investigational Site

Randwick, New South Wales, Australia

Site Status

GSK Investigational Site

Auchenflower, Queensland, Australia

Site Status

GSK Investigational Site

Chermside, Queensland, Australia

Site Status

GSK Investigational Site

Kippa-Ring, Queensland, Australia

Site Status

GSK Investigational Site

Woodville, South Australia, Australia

Site Status

GSK Investigational Site

Cheltenham, Victoria, Australia

Site Status

GSK Investigational Site

Heidelberg Heights, Victoria, Australia

Site Status

GSK Investigational Site

Kew, Victoria, Australia

Site Status

GSK Investigational Site

Nedlands, Western Australia, Australia

Site Status

GSK Investigational Site

Hall in Tirol, , Austria

Site Status

GSK Investigational Site

Vienna, , Austria

Site Status

GSK Investigational Site

Vienna, , Austria

Site Status

GSK Investigational Site

Vienna, , Austria

Site Status

GSK Investigational Site

Vienna, , Austria

Site Status

GSK Investigational Site

Kortrijk, , Belgium

Site Status

GSK Investigational Site

Leuven, , Belgium

Site Status

GSK Investigational Site

Woluwe-Saint-Lambert, , Belgium

Site Status

GSK Investigational Site

Sofia, , Bulgaria

Site Status

GSK Investigational Site

Sofia, , Bulgaria

Site Status

GSK Investigational Site

Sofia, , Bulgaria

Site Status

GSK Investigational Site

Varna, , Bulgaria

Site Status

GSK Investigational Site

Saint John, New Brunswick, Canada

Site Status

GSK Investigational Site

Kentville, Nova Scotia, Canada

Site Status

GSK Investigational Site

Kingston, Ontario, Canada

Site Status

GSK Investigational Site

Kingston, Ontario, Canada

Site Status

GSK Investigational Site

Ottawa, Ontario, Canada

Site Status

GSK Investigational Site

Ottawa, Ontario, Canada

Site Status

GSK Investigational Site

Peterborough, Ontario, Canada

Site Status

GSK Investigational Site

Toronto, Ontario, Canada

Site Status

GSK Investigational Site

Toronto, Ontario, Canada

Site Status

GSK Investigational Site

Toronto, Ontario, Canada

Site Status

GSK Investigational Site

Whitby, Ontario, Canada

Site Status

GSK Investigational Site

Charlottetown, Prince Edward Island, Canada

Site Status

GSK Investigational Site

Greenfield Park, Quebec, Canada

Site Status

GSK Investigational Site

Montreal, Quebec, Canada

Site Status

GSK Investigational Site

Montreal, Quebec, Canada

Site Status

GSK Investigational Site

Sherbrooke, Quebec, Canada

Site Status

GSK Investigational Site

Sherbrooke, Quebec, Canada

Site Status

GSK Investigational Site

Regina, Saskatchewan, Canada

Site Status

GSK Investigational Site

Québec, , Canada

Site Status

GSK Investigational Site

Viña del Mar, Región de Valparaíso, Chile

Site Status

GSK Investigational Site

Providencia / Santiago, Región Metro de Santiago, Chile

Site Status

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Site Status

GSK Investigational Site

Olomouc, , Czechia

Site Status

GSK Investigational Site

Ostrava, , Czechia

Site Status

GSK Investigational Site

Prague, , Czechia

Site Status

GSK Investigational Site

Prague, , Czechia

Site Status

GSK Investigational Site

Prague, , Czechia

Site Status

GSK Investigational Site

Prague, , Czechia

Site Status

GSK Investigational Site

Prague, , Czechia

Site Status

GSK Investigational Site

Trutnov, , Czechia

Site Status

GSK Investigational Site

Helsinki, , Finland

Site Status

GSK Investigational Site

Kuopio, , Finland

Site Status

GSK Investigational Site

Bourg-en-Bresse, , France

Site Status

GSK Investigational Site

Caen, , France

Site Status

GSK Investigational Site

Dijon, , France

Site Status

GSK Investigational Site

Ivry, , France

Site Status

GSK Investigational Site

La Seyne-sur-Mer, , France

Site Status

GSK Investigational Site

Lille, , France

Site Status

GSK Investigational Site

Limoges, , France

Site Status

GSK Investigational Site

Luynes, , France

Site Status

GSK Investigational Site

Lyon, , France

Site Status

GSK Investigational Site

Marseille, , France

Site Status

GSK Investigational Site

Marseille, , France

Site Status

GSK Investigational Site

Metz, , France

Site Status

GSK Investigational Site

Nantes, , France

Site Status

GSK Investigational Site

Nantes, , France

Site Status

GSK Investigational Site

Nantes, , France

Site Status

GSK Investigational Site

Nantes, , France

Site Status

GSK Investigational Site

Nice, , France

Site Status

GSK Investigational Site

Paris, , France

Site Status

GSK Investigational Site

Pau, , France

Site Status

GSK Investigational Site

Rodez, , France

Site Status

GSK Investigational Site

Saint-Etienne, , France

Site Status

GSK Investigational Site

Saint-Ouen-la-Rouërie, , France

Site Status

GSK Investigational Site

Sautron, , France

Site Status

GSK Investigational Site

Tinténiac, , France

Site Status

GSK Investigational Site

Toulon, , France

Site Status

GSK Investigational Site

Toulouse, , France

Site Status

GSK Investigational Site

Tours, , France

Site Status

GSK Investigational Site

Vichy, , France

Site Status

GSK Investigational Site

Aalen, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Ellwangen, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Ludwigsburg, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Ostfildern, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Tübingen, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Ulm, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Alzenau in Unterfranken, Bavaria, Germany

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

Site Status

GSK Investigational Site

Nuremberg, Bavaria, Germany

Site Status

GSK Investigational Site

Regensburg, Bavaria, Germany

Site Status

GSK Investigational Site

Unterhaching, Bavaria, Germany

Site Status

GSK Investigational Site

Bad Saarow, Brandenburg, Germany

Site Status

GSK Investigational Site

Bad Homburg, Hesse, Germany

Site Status

GSK Investigational Site

Erbach im Odenwald, Hesse, Germany

Site Status

GSK Investigational Site

Achim, Lower Saxony, Germany

Site Status

GSK Investigational Site

Bockhorn, Lower Saxony, Germany

Site Status

GSK Investigational Site

Ganderkesee, Lower Saxony, Germany

Site Status

GSK Investigational Site

Göttingen, Lower Saxony, Germany

Site Status

GSK Investigational Site

Hanover, Lower Saxony, Germany

Site Status

GSK Investigational Site

Lüneburg, Lower Saxony, Germany

Site Status

GSK Investigational Site

Westerstede, Lower Saxony, Germany

Site Status

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, Germany

Site Status

GSK Investigational Site

Bad Honnef, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Baesweiler, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Bergisch Gladbach, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Bochum, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Bochum, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Bochum, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Cologne, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Duisburg, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Düren, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Hattingen, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Jülich, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Krefeld, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Siegen, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Chemnitz, Saxony, Germany

Site Status

GSK Investigational Site

Dresden, Saxony, Germany

Site Status

GSK Investigational Site

Dresden, Saxony, Germany

Site Status

GSK Investigational Site

Leipzig, Saxony, Germany

Site Status

GSK Investigational Site

Leipzig, Saxony, Germany

Site Status

GSK Investigational Site

Gera, Thuringia, Germany

Site Status

GSK Investigational Site

Jena, Thuringia, Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Hamburg, , Germany

Site Status

GSK Investigational Site

Hamburg, , Germany

Site Status

GSK Investigational Site

Athens, , Greece

Site Status

GSK Investigational Site

Athens, , Greece

Site Status

GSK Investigational Site

Melíssia, , Greece

Site Status

GSK Investigational Site

Thessaloniki, , Greece

Site Status

GSK Investigational Site

Hong Kong, , Hong Kong

Site Status

GSK Investigational Site

Shatin, , Hong Kong

Site Status

GSK Investigational Site

Győr, , Hungary

Site Status

GSK Investigational Site

Szeged, , Hungary

Site Status

GSK Investigational Site

Hyderabad, , India

Site Status

GSK Investigational Site

Nagpur, , India

Site Status

GSK Investigational Site

New Delhi, , India

Site Status

GSK Investigational Site

Pune, , India

Site Status

GSK Investigational Site

Varanasi, , India

Site Status

GSK Investigational Site

Chieti Scalo, Abruzzo, Italy

Site Status

GSK Investigational Site

Napoli, Campania, Italy

Site Status

GSK Investigational Site

San Felice A Cancello Caserta, Campania, Italy

Site Status

GSK Investigational Site

Rome, Lazio, Italy

Site Status

GSK Investigational Site

Rome, Lazio, Italy

Site Status

GSK Investigational Site

Rome, Lazio, Italy

Site Status

GSK Investigational Site

Brescia, Lombardy, Italy

Site Status

GSK Investigational Site

Milan, Lombardy, Italy

Site Status

GSK Investigational Site

Milan, Lombardy, Italy

Site Status

GSK Investigational Site

Pavia, Lombardy, Italy

Site Status

GSK Investigational Site

Rho, Lombardy, Italy

Site Status

GSK Investigational Site

Torrette (AN), The Marches, Italy

Site Status

GSK Investigational Site

Arezzo, Tuscany, Italy

Site Status

GSK Investigational Site

Florence, Tuscany, Italy

Site Status

GSK Investigational Site

Pisa, Tuscany, Italy

Site Status

GSK Investigational Site

Monterrey, Nuevo León, Mexico

Site Status

GSK Investigational Site

Monterrey, Nuevo León, Mexico

Site Status

GSK Investigational Site

México, , Mexico

Site Status

GSK Investigational Site

's-Hertogenbosch, , Netherlands

Site Status

GSK Investigational Site

Alkmaar, , Netherlands

Site Status

GSK Investigational Site

Blaricum, , Netherlands

Site Status

GSK Investigational Site

Hengelo, , Netherlands

Site Status

GSK Investigational Site

Hilversum, , Netherlands

Site Status

GSK Investigational Site

The Hague, , Netherlands

Site Status

GSK Investigational Site

Pasig, , Philippines

Site Status

GSK Investigational Site

Bydgoszcz, , Poland

Site Status

GSK Investigational Site

Bydgoszcz, , Poland

Site Status

GSK Investigational Site

Katowice, , Poland

Site Status

GSK Investigational Site

Mosina, , Poland

Site Status

GSK Investigational Site

Poznan, , Poland

Site Status

GSK Investigational Site

Sopot, , Poland

Site Status

GSK Investigational Site

Warsaw, , Poland

Site Status

GSK Investigational Site

Coimbra, , Portugal

Site Status

GSK Investigational Site

Lisbon, , Portugal

Site Status

GSK Investigational Site

Bratislava, , Slovakia

Site Status

GSK Investigational Site

Bratislava, , Slovakia

Site Status

GSK Investigational Site

Bratislava, , Slovakia

Site Status

GSK Investigational Site

Košice, , Slovakia

Site Status

GSK Investigational Site

Ljubljana, , Slovenia

Site Status

GSK Investigational Site

Šempeter v Savinj. Dolini, , Slovenia

Site Status

GSK Investigational Site

Loeventstein, , South Africa

Site Status

GSK Investigational Site

Oakdale, , South Africa

Site Status

GSK Investigational Site

Richards Bay, , South Africa

Site Status

GSK Investigational Site

Rosebank, , South Africa

Site Status

GSK Investigational Site

Somerset West, , South Africa

Site Status

GSK Investigational Site

Waverley, Bloemfontein, , South Africa

Site Status

GSK Investigational Site

Willows, X14, Pretoria, , South Africa

Site Status

GSK Investigational Site

Seongnam-si, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Burgos, , Spain

Site Status

GSK Investigational Site

Castellon, , Spain

Site Status

GSK Investigational Site

Elche (Alicante), , Spain

Site Status

GSK Investigational Site

Girona, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Murcia, , Spain

Site Status

GSK Investigational Site

Palma de Mallorca, , Spain

Site Status

GSK Investigational Site

Tarrasa, Barcelona, , Spain

Site Status

GSK Investigational Site

Valencia, , Spain

Site Status

GSK Investigational Site

Jönköping, , Sweden

Site Status

GSK Investigational Site

Kalix, , Sweden

Site Status

GSK Investigational Site

Mölndal, , Sweden

Site Status

GSK Investigational Site

Sundsvall, , Sweden

Site Status

GSK Investigational Site

Umeå, , Sweden

Site Status

GSK Investigational Site

Blackpool, Lancashire, United Kingdom

Site Status

GSK Investigational Site

Bradford, , United Kingdom

Site Status

GSK Investigational Site

Liverpool, , United Kingdom

Site Status

GSK Investigational Site

West of Scotland Science Park, Glasgow, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil Japan Malaysia Singapore Switzerland United States Argentina Australia Austria Belgium Bulgaria Canada Chile Czechia Finland France Germany Greece Hong Kong Hungary India Italy Mexico Netherlands Philippines Poland Portugal Slovakia Slovenia South Africa South Korea Spain Sweden United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21592048 (View on PubMed)

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Individual Participant Data Set

View Document

Document Type: Informed Consent Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Dataset Specification

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://www.clinicalstudydatarequest.com

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AVA102675

Identifier Type: -

Identifier Source: org_study_id