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A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease

26 novembre 2013 aggiornato da: JANSSEN Alzheimer Immunotherapy Research & Development, LLC

A Phase 3 Extension, Multicenter, Double-Blind, Long-Term Safety and Tolerability Treatment Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Alzheimer's Disease Who Participated in Study ELN115727-301 or Study ELN115727-302.

The purpose of this study is to assess the long-term safety and tolerability of Bapineuzumab (AAB-001, ELN115727) in subjects with Alzheimer's disease who participated in study ELN115727-301 or study ELN115727-302.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

896

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Austria
    • Styria
      • Graz, Styria, Austria, 8036
        • Landeskrankenhaus- Universitätsklinikum Graz
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary, Foothills Medical Centre
    • British Columbia
      • Kamloops, British Columbia, Canada, V2C 1K7
        • Medical Arts Health Research Group
      • Kelowna, British Columbia, Canada, V1Y 3G8
        • Medical Arts Health Research Group
    • Ontario
      • Kingston, Ontario, Canada, K7L 5G2
        • Queens University Memorial Clinics
      • London, Ontario, Canada, N6C 5J1
        • Parkwood Hospital
      • Ottawa, Ontario, Canada, K1N 5C8
        • Bruyère Continuing Care
      • Toronto, Ontario, Canada, M3B 2S7
        • Neurology Research Inc
      • Toronto, Ontario, Canada, M6M 3Z5
        • Toronto Centre for Memory and Aging
      • Whitby, Ontario, Canada, L1N 5S9
        • Ontario Shores Centre for Mental Health Sciences
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2J2
        • Neuro Rive-Sud Memory Clinic
      • Montréal, Quebec, Canada, H1T 2M4
        • Hôpital Maisonneuve-Rosemont
      • Montréal, Quebec, Canada, H3T 1E2
        • Sir Mortimer B. Davis, Jewish General Hospital
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • Diex Research Sherbrooke Inc.
      • Verdun, Quebec, Canada, H4H 1R3
        • Douglas Mental Health University Institute
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35205
        • University of Alabama Hospital
    • Arizona
      • Goodyear, Arizona, Stati Uniti, 85395
        • Dedicated Clinical Research, Inc.
      • Phoenix, Arizona, Stati Uniti, 85006
        • Banner Alzheimer's Institute
      • Phoenix, Arizona, Stati Uniti, 85050
        • HOPE Research Institute, LLC
      • Sun City, Arizona, Stati Uniti, 85351
        • Banner Research Institute
      • Tucson, Arizona, Stati Uniti, 85724
        • University of Arizona College of Medicine, Health Sciences Center
      • Tucson, Arizona, Stati Uniti, 85741
        • Northwest NeuroSpecialists, PLLC
    • Arkansas
      • Little Rock, Arkansas, Stati Uniti, 72205
        • Clinical Trials, Inc.
    • California
      • Berkeley, California, Stati Uniti, 94705
        • East Bay Physicians Medical Group
      • Carson, California, Stati Uniti, 90746
        • AVI Clinical Research
      • Costa Mesa, California, Stati Uniti, 92626
        • ATP Clinical Research, Inc.
      • Encino, California, Stati Uniti, 91316
        • Pharmacology Research Institute
      • Fresno, California, Stati Uniti, 93720
        • Margolin Brain Institute
      • Fullerton, California, Stati Uniti, 92835
        • Neurology Center of North Orange County
      • La Jolla, California, Stati Uniti, 92037
        • University of California San Diego
      • La Jolla, California, Stati Uniti, 92037
        • Coordinated Clinical Research
      • Laguna Hills, California, Stati Uniti, 92653
        • Senior Clinical Trials, Inc.
      • Long Beach, California, Stati Uniti, 90806
        • Collaborative Neuroscience Network, Inc.
      • Los Alamitos, California, Stati Uniti, 90720
        • Pharmacology Research Institute
      • Los Angeles, California, Stati Uniti, 90095
        • UCLA Department of Neurology
      • Newport Beach, California, Stati Uniti, 92660
        • Pharmacology Research Institute
      • Oceanside, California, Stati Uniti, 92056
        • Neurology Center
      • Orange, California, Stati Uniti, 92868
        • University of California, Irvine Medical Center
      • Pasadena, California, Stati Uniti, 91105
        • Neuro-Therapeutics, Inc.
      • Sacramento, California, Stati Uniti, 95816
        • Sutter Neuroscience Medical Group
      • Sacramento, California, Stati Uniti, 95817
        • University of California at Davis, Alzheimer's Disease Research Center
      • San Diego, California, Stati Uniti, 92123
        • Sharp Mesa Vista Hospital
      • San Diego, California, Stati Uniti, 92123
        • Artemis Institute for Clinical Research
      • San Francisco, California, Stati Uniti, 94143
        • University of California San Francisco
      • San Francisco, California, Stati Uniti, 94109
        • San Francisco Clinical Research Center
      • Santa Monica, California, Stati Uniti, 90404
        • Neurological Research Institute
      • Sherman Oaks, California, Stati Uniti, 91403
        • Schuster Medical Research Institute
      • Walnut Creek, California, Stati Uniti, 94596
        • Diablo Clinical Research, Inc
    • Colorado
      • Boulder, Colorado, Stati Uniti, 80304
        • Alpine Clinical Research Center
      • Denver, Colorado, Stati Uniti, 80218
        • Mile High Research Center
      • Fort Collins, Colorado, Stati Uniti, 80528
        • Advanced Neurosciences Research, Llc
    • Connecticut
      • Danbury, Connecticut, Stati Uniti, 06810
        • Associated Neurologists, PC
      • Fairfield, Connecticut, Stati Uniti, 06824
        • Associated Neurologists of Southern Connecticut, P.C.
      • New Haven, Connecticut, Stati Uniti, 06510
        • Yale University School of Medicine
      • New Haven, Connecticut, Stati Uniti, 06510
        • Institute For Neurodegenerative Disorders
      • Norwalk, Connecticut, Stati Uniti, 06851
        • Research Center for Clinical Studies, Inc.
      • Waterbury, Connecticut, Stati Uniti, 06708
        • Chase Medical Research, LLC
    • Delaware
      • Newark, Delaware, Stati Uniti, 19713
        • Christiana Care Neurology Specialists
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti, 20057
        • Georgetown University Medical Center
    • Florida
      • Atlantis, Florida, Stati Uniti, 33462
        • JEM Research, LLC
      • Bradenton, Florida, Stati Uniti, 34205
        • Bradenton Research Center, Inc.
      • Deerfield Beach, Florida, Stati Uniti, 33064
        • Quantum Laboratories, Inc.
      • Delray Beach, Florida, Stati Uniti, 33445
        • Brain Matters Research
      • Fort Lauderdale, Florida, Stati Uniti, 33308
        • Neurologic Consultants, PA
      • Fort Myers, Florida, Stati Uniti, 33912
        • Neuropsychiatric Research Center of Southwest Florida
      • Fort Myers, Florida, Stati Uniti, 33916
        • Clinical Physiology Associates, Inc
      • Fort Walton Beach, Florida, Stati Uniti, 32547
        • Emerald Coast Mood and Memory, PA.
      • Hallandale Beach, Florida, Stati Uniti, 33009
        • MD Clinical
      • Jacksonville, Florida, Stati Uniti, 32224
        • Mayo Clinic College of Medicine
      • Maitland, Florida, Stati Uniti, 32751
        • Neurology Associates
      • Melbourne, Florida, Stati Uniti, 32901
        • Melbourne Internal Medicine Associates
      • Miami, Florida, Stati Uniti, 33137
        • Miami Jewish Health Systems
      • Miami, Florida, Stati Uniti, 33173
        • Miami Research Associates
      • Miami, Florida, Stati Uniti, 33126
        • Pharmax Research Clinic, LLC
      • Miami, Florida, Stati Uniti, 33156
        • Allied Clinical Trials Inc.
      • Ocala, Florida, Stati Uniti, 34471
        • Renstar Medical Research
      • Orlando, Florida, Stati Uniti, 32806
        • Compass Research, LLC
      • Palm Beach Gardens, Florida, Stati Uniti, 33418
        • Palm Beach Neurological Center, Advanced Research Consultants, Inc.
      • Port Charlotte, Florida, Stati Uniti, 33952
        • Neurostudies, Inc.
      • Saint Petersburg, Florida, Stati Uniti, 33713
        • Suncoast Neuroscience Associates, Inc.
      • Sarasota, Florida, Stati Uniti, 34243
        • The Roskamp Institute, Inc
      • Tampa, Florida, Stati Uniti, 33609
        • Axiom Clinical Research of Florida
      • Tampa, Florida, Stati Uniti, 33613
        • Stedman Clinical Trials, LLC
      • Tampa, Florida, Stati Uniti, 33613
        • Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute
      • Tampa, Florida, Stati Uniti, 33613
        • University of South Florida Suncoast Alzheimer's and Gerontology Center
      • West Palm Beach, Florida, Stati Uniti, 33407
        • Premiere Research Institute
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30342
        • NeuroTrials Research, Inc.
      • Atlanta, Georgia, Stati Uniti, 30322
        • Emory University, School of Medicine
      • Atlanta, Georgia, Stati Uniti, 30327
        • Multiple Sclerosis Center of Atlanta
      • Columbus, Georgia, Stati Uniti, 31909
        • Medical Research and Health Education Foundation, Inc.
      • Columbus, Georgia, Stati Uniti, 31909
        • Medical Research and Health Education Foundation, Inc
      • Decatur, Georgia, Stati Uniti, 30033
        • Dekalb Neurology Associates, LLC
      • Lawrenceville, Georgia, Stati Uniti, 30045
        • Gwinnett Medical Center
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60637
        • University of Chicago Medical Center
      • Elk Grove Village, Illinois, Stati Uniti, 60007
        • Alexian Brothers Neuroscience Institute
      • Peoria, Illinois, Stati Uniti, 61602
        • Methodist Medical Center of Illinois
      • Springfield, Illinois, Stati Uniti, 62794
        • Southern Illinois University School of Medicine
    • Indiana
      • Elkhart, Indiana, Stati Uniti, 46514
        • Elkhart Clinic, LLC
      • Indianapolis, Indiana, Stati Uniti, 46202
        • Indiana University School of Medicine
    • Kansas
      • Kansas City, Kansas, Stati Uniti, 66160
        • The University of Kansas Medical Center
      • Lenexa, Kansas, Stati Uniti, 66214
        • MidAmerica Neuroscience Institute
    • Kentucky
      • Lexington, Kentucky, Stati Uniti, 40536
        • University of Kentucky
      • Lexington, Kentucky, Stati Uniti, 40513
        • Associates in Neurology, PSC
      • Paducah, Kentucky, Stati Uniti, 42003
        • Four Rivers Clinical Research, Inc.
    • Louisiana
      • Lake Charles, Louisiana, Stati Uniti, 70629
        • Lake Charles Clinical Trials
      • Shreveport, Louisiana, Stati Uniti, 71104
        • J. Gary Booker, MD, APMC
    • Maine
      • Scarborough, Maine, Stati Uniti, 04074
        • Maine Medical Partners Neurology
    • Maryland
      • Rockville, Maryland, Stati Uniti, 20850
        • CBH Health, LLC
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02118
        • Boston University School of Medicine
      • Boston, Massachusetts, Stati Uniti, 02115
        • Brigham and Women's Hospital, Dept. of Neurology
      • Haverhill, Massachusetts, Stati Uniti, 01830
        • ActivMed Practices and Research, Inc.
      • Newton, Massachusetts, Stati Uniti, 02459
        • Neurocare, Inc.
      • Pittsfield, Massachusetts, Stati Uniti, 01201
        • Neuroscience Research of the Berkshires
      • Plymouth, Massachusetts, Stati Uniti, 02360
        • Donald S. Marks, MD, PC
      • Springfield, Massachusetts, Stati Uniti, 01104
        • Springfield Neurology Associates, LLC
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48105
        • University of Michigan Medical Center
      • Detroit, Michigan, Stati Uniti, 48202
        • Henry Ford Hospital
      • East Lansing, Michigan, Stati Uniti, 48824
        • Michigan State University
      • Kalamazoo, Michigan, Stati Uniti, 49048
        • Borgess Medical Center/Borgess Research Institute
    • Minnesota
      • Rochester, Minnesota, Stati Uniti, 55905
        • Mayo Clinic
    • Mississippi
      • Hattiesburg, Mississippi, Stati Uniti, 39401
        • Hattiesburg Clinic
    • Missouri
      • Kansas City, Missouri, Stati Uniti, 64114
        • Center For Pharmaceutical Research
      • Saint Louis, Missouri, Stati Uniti, 63104
        • Saint Louis University School of Medicine
      • Saint Lous, Missouri, Stati Uniti, 63108
        • Washington University School of Medicine
    • Montana
      • Billings, Montana, Stati Uniti, 59101
        • Deaconess Billings Clinical Research Center
      • Great Falls, Montana, Stati Uniti, 59405
        • Advanced Neurology Specialists
    • Nebraska
      • Omaha, Nebraska, Stati Uniti, 68198
        • University of Nebraska Medical Center
    • New Jersey
      • Eatontown, New Jersey, Stati Uniti, 07724
        • Memory Enhancement Center of America, Inc.
      • Manchester, New Jersey, Stati Uniti, 08759
        • Alzheimer's Research Corporation
      • Princeton, New Jersey, Stati Uniti, 08540
        • Global Medical Institutes, LLC
      • Toms River, New Jersey, Stati Uniti, 08755
        • Shore Neurology, PA
    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti, 87109
        • Albuquerque Neuroscience, Inc.
    • New York
      • Albany, New York, Stati Uniti, 12205
        • Upstate Clinical Research, LLC
      • Albany, New York, Stati Uniti, 12208
        • Neurological Associates of Albany, PC
      • Albany, New York, Stati Uniti, 12208
        • Neuroscience Research Center at Albany Medical Center
      • Elmsford, New York, Stati Uniti, 10523
        • Advanced BioBehavioral Sciences
      • Latham, New York, Stati Uniti, 12110
        • Empire Neurology, PC
      • Liverpool, New York, Stati Uniti, 13088
        • Neurological Care of Central New York
      • New Hyde Park, New York, Stati Uniti, 11040
        • Parker Jewish Institute for Health Care and Rehabilitation
      • New York, New York, Stati Uniti, 10032
        • Columbia University Medical Center
      • New York, New York, Stati Uniti, 10016
        • New York University School of Medicine/Psychiarty
      • Orangeburg, New York, Stati Uniti, 10962
        • Nathan S. Kline Institute for Psychiatric Research
      • Rochester, New York, Stati Uniti, 14620
        • University of Rochester Medical Center, Monroe Community Hospital
    • North Carolina
      • Durham, North Carolina, Stati Uniti, 27710
        • Duke University Medical Center
      • Hickory, North Carolina, Stati Uniti, 28601
        • Clinical Trials of America, Inc
      • Raleigh, North Carolina, Stati Uniti, 27607
        • Raleigh Neurology Associates
    • Ohio
      • Canton, Ohio, Stati Uniti, 44718
        • Neuro-Behavioral Clinical Research, Inc.
      • Columbus, Ohio, Stati Uniti, 43210
        • Ohio State University, Dept. of Neurology
      • Dayton, Ohio, Stati Uniti, 45417
        • Neurology Specialists, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73112
        • Lynn Health Science Institute
      • Oklahoma City, Oklahoma, Stati Uniti, 73112
        • Red River Medical Research Center, LLC
    • Oregon
      • Medford, Oregon, Stati Uniti, 97504
        • Providence Medical Group-Medford Neurology
      • Portland, Oregon, Stati Uniti, 97239
        • Oregon Health and Science University
      • Portland, Oregon, Stati Uniti, 97223
        • Summit Research Group, LLC
      • Portland, Oregon, Stati Uniti, 97225
        • Providence Health Service System, AD Center, Brain Institute
    • Pennsylvania
      • Abington, Pennsylvania, Stati Uniti, 19001
        • Abington Neurological Associates, Ltd.
      • Allentown, Pennsylvania, Stati Uniti, 18103
        • Lehigh Valley Health Network
      • Jenkintown, Pennsylvania, Stati Uniti, 19046
        • The Clinical Trial Center, LLC
      • Philadelphia, Pennsylvania, Stati Uniti, 19102
        • Drexel University College of Medicine
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • Penn Memory Center
      • Philadelphia, Pennsylvania, Stati Uniti, 19107
        • Jefferson Hospital for Neuroscience
      • Pittsburgh, Pennsylvania, Stati Uniti, 15213
        • University of Pittsburgh
      • Pittsburgh, Pennsylvania, Stati Uniti, 15206
        • Clinical Trials Research Services, LLC
    • Rhode Island
      • East Providence, Rhode Island, Stati Uniti, 02914
        • Rhode Island Mood and Memory Research Institute
      • Providence, Rhode Island, Stati Uniti, 02903
        • Rhode Island Hospital
      • Providence, Rhode Island, Stati Uniti, 02906
        • Butler Hospital
    • South Carolina
      • North Charleston, South Carolina, Stati Uniti, 29406
        • Medical University of South Carolina
    • South Dakota
      • Sioux Falls, South Dakota, Stati Uniti, 57105
        • Avera Research Institute
    • Tennessee
      • Cordova, Tennessee, Stati Uniti, 38018
        • Neurology Clinic, P.C.
      • Johnson City, Tennessee, Stati Uniti, 37614
        • East Tennessee State University
      • Knoxville, Tennessee, Stati Uniti, 37920
        • Volunteer Research Group
      • Nashville, Tennessee, Stati Uniti, 37203
        • Psychiatric Consultants, PC
    • Texas
      • Austin, Texas, Stati Uniti, 78757
        • Senior Adults Specialty Research (Sasr)
      • Dallas, Texas, Stati Uniti, 75214
        • Texas Neurology, PA
      • Dallas, Texas, Stati Uniti, 75390
        • University of Texas Southwestern Medical Center, Dept. of Neurology
      • DeSoto, Texas, Stati Uniti, 75115
        • InSite Clinical Research
      • Fort Worth, Texas, Stati Uniti, 76106
        • University of North Texas Health Science Center at Fort Worth
      • Houston, Texas, Stati Uniti, 77030
        • Baylor College of Medicine
      • San Antonio, Texas, Stati Uniti, 78229
        • Innovative Clinical Trials
      • San Antonio, Texas, Stati Uniti, 78231
        • Integra Clinical Research, Llc
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84107
        • Wasatch Clinical Research
      • Salt Lake City, Utah, Stati Uniti, 84108
        • University of Utah, Dept. of Neurology
    • Vermont
      • Bennington, Vermont, Stati Uniti, 05201
        • The Memory Clinic
      • Burlington, Vermont, Stati Uniti, 05401
        • Fletcher Allen Health Care
    • Virginia
      • Alexandria, Virginia, Stati Uniti, 22304
        • Innovative Clinical Research Center
      • Charlottesville, Virginia, Stati Uniti, 22903
        • University of Virginia
      • Richmond, Virginia, Stati Uniti, 23230
        • Alliance Research Group, LLC
    • Washington
      • Seattle, Washington, Stati Uniti, 98108
        • University of Washington Veterans Affairs
      • Seattle, Washington, Stati Uniti, 98144
        • Pacific Medical Centers
    • Wisconsin
      • Milwaukee, Wisconsin, Stati Uniti, 53226
        • Medical College of Wisconsin, Froedtert Memorial Lutheran Hospital
      • Waukesha, Wisconsin, Stati Uniti, 53188
        • Independent Psychiatric Consultants

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

51 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Diagnosis of probable AD
  • Must have completed study 301 or study 302; and have completed Visit 15 (Week 78)
  • Brain MRI scan to evaluate safety from Study 301 or 302 at Visit 14/Week 71
  • Caregiver able to attend all clinic visits with patient

Exclusion Criteria:

  • Any new medical contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs or ECG examination (eg, atrial fibrillation) that precludes continued or initiation of treatment with bapineuzumab or participation in the study
  • Screening visit brain MRI scan (MRI from Study 301 or 302 Visit 14/Week 71) indicative of any significant abnormality not approved by the medical monitor prior to enrollment
  • Current use of experimental medications for AD (other than bapineuzumab) and all other experimental medications, herbal preparations containing Ginko biloba, and anticoagulants (except the use of aspirin 325mg/day or less, Plavix, and Persantine but not for stroke)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Bapineuzumab 0.5 mg/kg
0.5 mg/kg
Droga: Bapineuzumab

0.5 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.

1.0 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.
Comparatore attivo: Bapineuzumab 1.0 mg/kg
1.0 mg/kg
Droga: Bapineuzumab

0.5 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.

1.0 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Clinically important changes in safety assessment results including vital signs, weight, clinical laboratory tests, electrocardiograms (ECGs), brain magnetic resonance imaging (MRI), physical and neurological examinations, and infusion site assessments.
Lasso di tempo: Varies according to assessment: vital signs and adverse events on ongoing basis; MRI and ECG as required per protocol
Varies according to assessment: vital signs and adverse events on ongoing basis; MRI and ECG as required per protocol

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
To evaluate the efficacy of long term treatment of IV administered bapineuzumab in subjects with AD.
Lasso di tempo: The trial duration is expected to be approximately 4 years. The study will last up to the time of commercial launch of bapineuzumab, or termination of the clinical trials program, whichever comes first
The trial duration is expected to be approximately 4 years. The study will last up to the time of commercial launch of bapineuzumab, or termination of the clinical trials program, whichever comes first

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Collaboratori

Pfizer

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2009

Completamento primario (Effettivo)

1 settembre 2012

Completamento dello studio (Effettivo)

1 settembre 2012

Date di iscrizione allo studio

Primo inviato

7 luglio 2009

Primo inviato che soddisfa i criteri di controllo qualità

9 luglio 2009

Primo Inserito (Stima)

13 luglio 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

20 dicembre 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 novembre 2013

Ultimo verificato

1 novembre 2013

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ELN115727-351

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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