Extension Study for 2993-112
23 febbraio 2015 aggiornato da: AstraZeneca
An Open-Label Extension Study of Protocol 2993-112 to Examine the Long-Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of AC2993 Given Two Times a Day to Subjects Treated With Metformin Alone
This multicenter, open-label extension study of Protocol 2993-112 is designed to assess long-term glucose control as measured by HbA1c (glycosylated hemoglobin) and to evaluate long-term safety and tolerability in subjects treated with metformin who receive subcutaneously injected AC2993 (10 mcg) administered twice daily.
Subjects completing Protocol 2993-112 are eligible to enroll.
Panoramica dello studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
225
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
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Alberta
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Calgary, Alberta, Canada, T3B 0M3
- Calgary Metabolic Education and Research Center
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Edmonton, Alberta, Canada, T6G 2B7
- Walter McKenzie Health Sciences Centre
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 1Y6
- St. Paul's Hospital, Research Services
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1R9
- Health Sciences Center
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Ontario
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London, Ontario, Canada, N6A 4V2
- University of Western Ontario
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Quebec
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Montreal, Quebec, Canada, H3A 1A1
- McGill Nutrition and Food Science Center
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Ste. Foy, Quebec, Canada, G1V 4G2
- Centre hospitalier
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Alabama
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Anniston, Alabama, Stati Uniti, 36207
- Pinnacle Research Group
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Birmingham, Alabama, Stati Uniti, 35206
- Parkway Medical Center
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Birmingham, Alabama, Stati Uniti, 35235
- Alabama Clinical Therapeutics
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Eclectic, Alabama, Stati Uniti, 36024
- Eclectic Family Care
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Haleyville, Alabama, Stati Uniti, 35565
- Winston Physician Services
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Hueytown, Alabama, Stati Uniti, 35023
- Simon Williamson Clinic
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Montgomery, Alabama, Stati Uniti, 36106
- Extended Arm Physicians/ Southern Drug
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Tallassee, Alabama, Stati Uniti, 36078
- Southern Drug Research Network
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Arizona
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Chandler, Arizona, Stati Uniti, 85224
- Mesa Center for Clinical Research
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Mesa, Arizona, Stati Uniti, 85201
- Clinic of Physicians and Surgeons, Ltd.
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Mesa, Arizona, Stati Uniti, 85204
- ANA Ventures, LLC
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Phoenix, Arizona, Stati Uniti, 85020
- Physicians at the Peak
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Phoenix, Arizona, Stati Uniti, 85016
- Lovelace Scientific Resources
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Tucson, Arizona, Stati Uniti, 85712
- Advanced Clinical Therapeutics
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Arkansas
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Fayetteville, Arkansas, Stati Uniti, 72701
- First Care Family Doctors
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Little Rock, Arkansas, Stati Uniti, 72205
- CAVHS
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Little Rock, Arkansas, Stati Uniti, 72205
- Physicians Group Research Clinic, LLC
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California
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Anaheim, California, Stati Uniti, 92801
- Advanced Clinical Research Institute
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Atherton, California, Stati Uniti, 94027
- Endocrine Metabolic Medical Center
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Bakersfield, California, Stati Uniti, 93309
- Mitchell Research Group, Inc.
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Burlingame, California, Stati Uniti, 94010
- William Zigrang, M.D.
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Chula Vista, California, Stati Uniti, 91910
- International Clinical Research Network
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Colton, California, Stati Uniti, 92324
- Arrowhead Regional Medical Center
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Concord, California, Stati Uniti, 94520
- East Bay Clinical Trial Center
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Encino, California, Stati Uniti, 91436
- Medical Group of Encino
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Fremont, California, Stati Uniti, 94538
- Mowry Clinical Research
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Fresno, California, Stati Uniti, 93720
- Valley Research
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Fresno, California, Stati Uniti, 93720-2955
- SARC Research Center
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Irvine, California, Stati Uniti, 92618
- Irvine Clinical Research Center
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La Jolla, California, Stati Uniti, 92037
- Whittier Institute for Diabetes
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Long Beach, California, Stati Uniti, 90806
- Harriman Jones Medical Group
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Los Gatos, California, Stati Uniti, 95032
- Richard Cherlin, M.D.
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Modesto, California, Stati Uniti, 95350
- Tushar Modi, M.D.
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Moreno Valley, California, Stati Uniti, 92553
- Dr. Martinez Medical Clinic
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Pasadena, California, Stati Uniti, 91105
- Arroyo Seco Medical Group
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Rancho Mirage, California, Stati Uniti, 92270
- Elke Jost-Vu, M.D.
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Redwood City, California, Stati Uniti, 94062
- Comprehensive Diabetes-Endocrine Medical Associates
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San Diego, California, Stati Uniti, 92103
- nTouch
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San Diego, California, Stati Uniti, 92161
- Veterans Medical Research Foundation
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San Diego, California, Stati Uniti, 92108
- Radiant Research
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San Diego, California, Stati Uniti, 92108
- San Diego Endocrine and Medical Clinic
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San Mateo, California, Stati Uniti, 94401
- Diabetes Research Institute of Mills Peninsula
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Santa Ana, California, Stati Uniti, 92701
- Advanced Clinical Research Institute
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Santa Monica, California, Stati Uniti, 90404
- Pacific Clinical Research
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Signal Hill, California, Stati Uniti, 90755
- West Coast Clinical Trials
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Vista, California, Stati Uniti, 92083
- Protocare Trials at Sharp Mission Park
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Walnut Creek, California, Stati Uniti, 94598
- Diablo Clinical Research
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Colorado
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Denver, Colorado, Stati Uniti, 80262
- University of Colorado-Barbara Davis Center for Childhood Diabetes
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Connecticut
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Waterbury, Connecticut, Stati Uniti, 06708
- Pheonix International Medicine Associates
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Delaware
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Newark, Delaware, Stati Uniti, 19713
- Health Core at Health Care Center Christiana
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 20037
- George Washington University
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Washington, District of Columbia, Stati Uniti, 20003-4393
- MedStar Clinical Research
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Florida
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Clearwater, Florida, Stati Uniti, 33765
- Clinical Research of West Florida, Inc.
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Clearwater, Florida, Stati Uniti, 33756
- Morton Plant Mease Health Care
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Daytona Beach, Florida, Stati Uniti, 32114
- Atlantic Institute of Clinical Research
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Daytona Beach, Florida, Stati Uniti, 32114
- Halifax Clinical Research Institute
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Ft. Myers, Florida, Stati Uniti, 33901
- Internal Medical Associates
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Gainesville, Florida, Stati Uniti, 32605
- Clin Sci International
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Gainesville, Florida, Stati Uniti, 32610-0226
- University of FL
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Hollywood, Florida, Stati Uniti, 33023
- South Florida Clinical Research Center
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Jacksonville, Florida, Stati Uniti, 32250
- Health Trials 3000
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Jupiter, Florida, Stati Uniti, 33458
- Jupiter Research Institute
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Maitland, Florida, Stati Uniti, 32751
- ICSL Clinical Studies
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Miami, Florida, Stati Uniti, 33176
- Baptist Diabetes Associates
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New Port Richey, Florida, Stati Uniti, 34652
- Suncoast Clinical Research
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Orlando, Florida, Stati Uniti, 32801
- VRG Research
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Palm Harbor, Florida, Stati Uniti, 34684
- Highland Lakes Medical Center
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Tallahassee, Florida, Stati Uniti, 32308
- Tallahassee Endocrine Associates
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Tampa, Florida, Stati Uniti, 33614
- Tampa Medical Group
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Tampa, Florida, Stati Uniti, 33612
- Biostator / USF Diabetes Center
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Vero Beach, Florida, Stati Uniti, 32967
- Diabetes and Endocrine Associates of the Treasure Co
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West Palm Beach, Florida, Stati Uniti, 33407
- Radiant Research
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West Palm Beach, Florida, Stati Uniti, 33401
- Metabolic Research Institute, Inc.
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Georgia
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Atlanta, Georgia, Stati Uniti, 30342
- Clinical Research Atlanta
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Atlanta, Georgia, Stati Uniti, 30328
- ICSL-Clinical Studies
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Columbus, Georgia, Stati Uniti, 31901
- Columbus Metabolic Foundation
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Decatur, Georgia, Stati Uniti, 30033
- nTouch Research Corporation
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Hawaii
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Honolulu, Hawaii, Stati Uniti, 96813
- East-West Medical Research Institute
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Honolulu, Hawaii, Stati Uniti, 96814
- Radiant Research
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Idaho
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Meridian, Idaho, Stati Uniti, 83642
- St. Luke's Family Health
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Illinois
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Belvidere, Illinois, Stati Uniti, 61008
- University Primary Care Center at Belvidere
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Chicago, Illinois, Stati Uniti, 60612
- Cook County Hospital
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Chicago, Illinois, Stati Uniti, 60610
- Illinois Center for Clinical Trials
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Chicago, Illinois, Stati Uniti, 60602
- Northwestern Memorail Physicians Group
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Libertyville, Illinois, Stati Uniti, 60048
- Lake Forest Internal Medicine
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Libertyville, Illinois, Stati Uniti, 60048
- Winchester Research Group
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Springfield, Illinois, Stati Uniti, 62703
- Springfield Clinic
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Springfield, Illinois, Stati Uniti, 62704
- Springfield Diabetes and Endocrinology
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Indiana
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Fort Wayne, Indiana, Stati Uniti, 46804
- Medical Group of Fort Wayne
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Indianapolis, Indiana, Stati Uniti, 46202
- Indiana University Outpatient Clinical Research
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Indianapolis, Indiana, Stati Uniti, 46222
- American Health Network
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Indianapolis, Indiana, Stati Uniti, 46260
- Center for Metabolic and Hormonal Disorders
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South Bend, Indiana, Stati Uniti, 46601
- nTouch Research Corporation
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Iowa
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Des Moines, Iowa, Stati Uniti, 50314
- Ramona Holiday Diabetes Center
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Iowa City, Iowa, Stati Uniti, 52242-1009
- Diabetes Clinical Research and Programs
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Kansas
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Kansas City, Kansas, Stati Uniti, 66160
- Lipid, Atherosclerosis & Metabolic Clinic
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40509
- Central Kentucky Research Associates
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Lexington, Kentucky, Stati Uniti, 40503
- Kentucky Diabetes Center
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Lexington, Kentucky, Stati Uniti, 40536-9841
- University of Kentucky Metabolic Research Group
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Louisville, Kentucky, Stati Uniti, 40223
- MedResearch, Inc.
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Louisiana
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Metairie, Louisiana, Stati Uniti, 70001
- Drug Research Services
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New Orleans, Louisiana, Stati Uniti, 70119
- New Orleans Center for Clinical Research
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New Orleans, Louisiana, Stati Uniti, 70121
- Ochsner Clinic
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New Orleans, Louisiana, Stati Uniti, 70112
- New Orleans Institute of Clinical Investigation
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Maine
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Bangor, Maine, Stati Uniti, 04401
- Diabetes, Endocrine and Nutrition Center
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Maryland
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Baltimore, Maryland, Stati Uniti, 21229
- St. Agnes Health Care
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Baltimore, Maryland, Stati Uniti, 21201
- VA Medical Center
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Lanham, Maryland, Stati Uniti, 20706
- Doctors Research Associates of Maryland
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109
- University of Michigan-Endocrinology and Metabolism
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Bloomfield Hills, Michigan, Stati Uniti, 48302
- Grunberger Diabetes Medical Center
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Detroit, Michigan, Stati Uniti, 48202
- Henry Ford Health System
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Grand Rapids, Michigan, Stati Uniti, 49506
- Grand Rapids Associated Interns
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Kalamazoo, Michigan, Stati Uniti, 49009
- Westside Family Medical Center
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Minnesota
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic, Division of Endocrinology and Metabolism
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Mississippi
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Jackson, Mississippi, Stati Uniti, 39216
- University of Mississippi Medical Center
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Missouri
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Chesterfield, Missouri, Stati Uniti, 63017
- Diabetes and Endocrinology Specialists
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Excelsior Springs, Missouri, Stati Uniti, 64024
- Medical Arts Research Collaborative
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Kansas City, Missouri, Stati Uniti, 64111
- St Lukes Lipid and Diabetes Research Center
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Rolla, Missouri, Stati Uniti, 65401
- Mid Missouri Research Specialists, Inc.
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St. Louis, Missouri, Stati Uniti, 63128
- St. Louis Center for Clinical Research
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St. Louis, Missouri, Stati Uniti, 63141
- Radiant Research
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St. Peters, Missouri, Stati Uniti, 63376
- Midwest Pharmaceutical Research
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Montana
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Butte, Montana, Stati Uniti, 59701
- Mercury Street Medical
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68131
- Creighton Diabetes Center
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89102
- Lovelace Scientific Resources
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Las Vegas, Nevada, Stati Uniti, 89106
- ICSL
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New Hampshire
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Dover, New Hampshire, Stati Uniti, 03820
- Endocrinology and Diabetes Consultants, P.C.
-
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New Jersey
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Jersey City, New Jersey, Stati Uniti, 07306
- HIS Clinical Research
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Moorestown, New Jersey, Stati Uniti, 08057
- Radiant Research
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Mt. Laurel, New Jersey, Stati Uniti, 08054
- Matrix Research Institute
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Passaic, New Jersey, Stati Uniti, 07055
- New Jersey Physicians
-
South Plainfield, New Jersey, Stati Uniti, 07080
- Anderson and Collins Clinical Research, Inc.
-
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87108
- Lovelace Scientific Resources
-
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New York
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Bronx, New York, Stati Uniti, 10467
- Albert Einstein College of Medicine of Yeshiva University
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Brooklyn, New York, Stati Uniti, 11203
- SUNY Downstate
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Brooklyn, New York, Stati Uniti, 11230
- Medical Network Services, P.C.
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Mineola, New York, Stati Uniti, 11501
- Winthrop University Hospital
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New York, New York, Stati Uniti, 10025
- St. Lukes Roosevelt Hospital
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New York, New York, Stati Uniti, 10032
- Naomi Berrie Diabetes Center at Columbia University
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New York, New York, Stati Uniti, 10033
- Heights Medical Care
-
New York, New York, Stati Uniti, 10032
- Irving Diabetes Research Unit at Columbia University
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Rochester, New York, Stati Uniti, 14609
- Rochester Clinical Research
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Yonkers, New York, Stati Uniti, 10710
- DOCS at Beth Israel Medical Center
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North Carolina
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Charlotte, North Carolina, Stati Uniti, 28209
- Metrolina Medical Research
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Charlotte, North Carolina, Stati Uniti, 28211
- Charlotte Clinical Research
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Durham, North Carolina, Stati Uniti, 27713
- UNC Diabetes Care Center
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Hickory, North Carolina, Stati Uniti, 28601
- Unifour Medical Research
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Wilmington, North Carolina, Stati Uniti, 28412
- New Hanover Medical Research Associates
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Winston-Salem, North Carolina, Stati Uniti, 27103
- Piedmont Medical Research
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Ohio
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Cleveland, Ohio, Stati Uniti, 44124
- Rapid Medical Research
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Columbus, Ohio, Stati Uniti, 43212
- Radiant Research
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Columbus, Ohio, Stati Uniti, 43210
- Ohio State University-Division of Endocrinology
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Mentor, Ohio, Stati Uniti, 44060
- University Mednet
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Mogadore, Ohio, Stati Uniti, 44260
- Comprehensive Research Services, Inc.
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Westlake, Ohio, Stati Uniti, 44145
- North Coast Institute of Diabetes and Endocrinology
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Oklahoma
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Clinton, Oklahoma, Stati Uniti, 73601
- Prime Care Clinical Research
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Oklahoma City, Oklahoma, Stati Uniti, 73104
- OU Health Sciences Center
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Oklahoma City, Oklahoma, Stati Uniti, 73103
- COR Clinical Research
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Oklahoma City, Oklahoma, Stati Uniti, 73112
- nTouch Research Corporation
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Tulsa, Oklahoma, Stati Uniti, 74104
- Utica Park Clinic
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Oregon
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Medford, Oregon, Stati Uniti, 97504
- Medford Medical Clinic
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Medford, Oregon, Stati Uniti, 97504
- Americas Doctors
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Portland, Oregon, Stati Uniti, 97232
- Legacy Clinical Research
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Portland, Oregon, Stati Uniti, 97201
- Radiant Research
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Portland, Oregon, Stati Uniti, 97210
- Portland Diabetes and Endocrinology Center
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Portland, Oregon, Stati Uniti, 97214
- Pacific Coast Clinical Coordinators, Inc.
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Pennsylvania
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Camp Hill, Pennsylvania, Stati Uniti, 17011
- Physicians for Clinical Research
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Horsham, Pennsylvania, Stati Uniti, 19044-12297
- Argus Research Laboratories
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Philadelphia, Pennsylvania, Stati Uniti, 19141
- Albert Einstein Medical Center
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Philadelphia, Pennsylvania, Stati Uniti, 19107
- Thomas Jefferson University Diabetes Research Center
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Philadelphia, Pennsylvania, Stati Uniti, 19146
- Philadelphia Health Associates
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Sellersville, Pennsylvania, Stati Uniti, 18960
- Elite Medical Research, Inc.
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Tipton, Pennsylvania, Stati Uniti, 16684
- Tipton Medical and Diagnostic Center
-
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Rhode Island
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East Providence, Rhode Island, Stati Uniti, 02914
- Safe Harbor Clinical Research
-
East Providence, Rhode Island, Stati Uniti, 02915
- ICSL-Providence
-
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29407
- Radiant Research
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Chester, South Carolina, Stati Uniti, 29706
- CNS Clinical Trials
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Mt. Pleasant, South Carolina, Stati Uniti, 29464
- Coastal Carolina Research Center
-
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Tennessee
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Alcoa, Tennessee, Stati Uniti, 37701
- Tennessee Valley Clinical Research Associates
-
Jackson, Tennessee, Stati Uniti, 38305
- Integrity Clinical Research
-
Johnson City, Tennessee, Stati Uniti, 37601
- Harmony Clinical Research
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Kingsport, Tennessee, Stati Uniti, 37660
- Holston Medical Group
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Knoxville, Tennessee, Stati Uniti, 37909
- Endocrine Consultants of ET
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Memphis, Tennessee, Stati Uniti, 38119
- The Endocrine Clinic
-
Milan, Tennessee, Stati Uniti, 38358
- Integrity Clinical Research
-
Nashville, Tennessee, Stati Uniti, 37203
- Mid State Endocrine Associates
-
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Texas
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Arlington, Texas, Stati Uniti, 76014
- Israel A. Hartman, M.D.
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Austin, Texas, Stati Uniti, 78705
- Central Texas Clinical Research
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Dallas, Texas, Stati Uniti, 75251
- Rafael Canadas M.D., P.A.
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Dallas, Texas, Stati Uniti, 75230
- Dallas Diabetes and Endocrinology Research Center
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El Paso, Texas, Stati Uniti, 79905
- Texas Tech University Health Sciences-Internal Medicine
-
El Paso, Texas, Stati Uniti, 79912
- Internal Medicine Associates
-
Fort Worth, Texas, Stati Uniti, 76107
- Lanier Education Research Network
-
Irving, Texas, Stati Uniti, 75038
- North Texas Clinical Research
-
Kingsville, Texas, Stati Uniti, 78363
- Dr. Humberto Bruschetta
-
Lake Jackson, Texas, Stati Uniti, 77566
- R/D Clinical Research, Inc.
-
McAllen, Texas, Stati Uniti, 78503
- South Texas Applied Research
-
San Antonio, Texas, Stati Uniti, 78207
- University of Texas Health Sciences Center-Texas Diabetes Institute
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San Antonio, Texas, Stati Uniti, 78229-3894
- Diabetes and Glandular Disease Clinic
-
San Antonio, Texas, Stati Uniti, 78205
- Sun Research Institute
-
San Antonio, Texas, Stati Uniti, 78229
- SAM Clinical Research
-
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Utah
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Salt Lake City, Utah, Stati Uniti, 84124
- Salt Lake Research
-
Salt Lake City, Utah, Stati Uniti, 84108
- Utah Diabetes Center at the University of Utah
-
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Virginia
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Arlington, Virginia, Stati Uniti, 22204
- Medical Associates of Northern Virginia
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Norfolk, Virginia, Stati Uniti, 23507
- Clinical Research Center-Eastern Virginia Medical School
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Richmond, Virginia, Stati Uniti, 23225
- Drs. Wigand, Wasserman, and Associates
-
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Washington
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Kirkland, Washington, Stati Uniti, 98034
- Evergreen Diabetes & Endocrinology
-
Lacey, Washington, Stati Uniti, 98516
- Olympic Medical Services
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Olympia, Washington, Stati Uniti, 98502
- West Olympia Internal Medicine
-
Renton, Washington, Stati Uniti, 98055
- Rainier Clinical Research Center
-
Spokane, Washington, Stati Uniti, 99202
- Rockwood Clinic
-
Spokane, Washington, Stati Uniti, 99201
- Northside Internal Medicine
-
Spokane, Washington, Stati Uniti, 99204
- Julia M. Hutchinson, M.D.
-
Wenatchee, Washington, Stati Uniti, 98801
- Wenatchee Valley Clinic
-
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West Virginia
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Charleston, West Virginia, Stati Uniti, 25304
- CAMC Clinical Trials Center
-
Charleston, West Virginia, Stati Uniti, 25301
- Hyperion Clinical Research
-
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Wisconsin
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Madison, Wisconsin, Stati Uniti, 53711
- University of Wisconsin West Clinic
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Milwaukee, Wisconsin, Stati Uniti, 53215
- Midwest Endocrinology Associates
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Milwaukee, Wisconsin, Stati Uniti, 53226
- VRG Research
-
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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
Da 16 anni a 75 anni (Bambino, Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
All of the following criteria are to be fulfilled for inclusion of an individual in the study unless the sponsor grants an exception:
- Has completed the 30-week triple-blind treatment initiation/active treatment periods in Protocol 2993-112, including all procedures required at the study termination visit (Week 30).
- Male or female. Female individuals must be either 1) postmenopausal as documented by serum FSH measurement unless using estrogen for hormone replacement therapy; or 2) of childbearing potential and used appropriate contraceptive methods (surgical sterility or oral, injected, barrier, intrauterine, or implanted contraceptives) for the duration of Protocol 2993-112. This individual must have a current, negative pregnancy test (human chorionic gonadotropin [HCG], beta subunit) regardless of birth control method used. The individual agrees to continue using birth control throughout the study to prevent pregnancy.
- Able to understand and sign a Protocol 2993-112E-specific informed consent form, communicate with the investigator, and understand and comply with the protocol requirements.
Individuals meeting any of the following criteria are to be excluded from the study unless the sponsor grants an exception:
- Has not completed Protocol 2993-112.
- Female individuals who are pregnant, lactating, or planning to become pregnant.
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: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Open-label AC2993
|
4-Week transition of AC2993 5 mcg subcutaneously injected twice daily followed by an open-ended period through study termination (up to 52 weeks) of AC2993 10 mcg subcutaneously injected twice daily
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in HbA1c from Day 1 of Protocol 2993-112 to Week 52 (or termination)
Lasso di tempo: Day 1 of study 2993-112 through extension study termination (up to Week 52)
|
Change in HbA1c from Visit 3 (Day 1) of Protocol 2993-112 to Visit 6E (Week 52) of the extension study and to each intermediate visit in the extension study will be calculated and summarized descriptively.
|
Day 1 of study 2993-112 through extension study termination (up to Week 52)
|
|
Change in body weight from Day 1 of Protocol 2993-112 to Week 52 (or termination)
Lasso di tempo: Day 1 of study 2993-112 through extension study termination (up to Week 52)
|
Change in body weight (KG) from Visit 3 (Day 1) of Protocol 2993-112 to Visit 6E (Week 52) of the extension study and to each intermediate visit in the extension study will be calculated and summarized descriptively.
|
Day 1 of study 2993-112 through extension study termination (up to Week 52)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
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 settembre 2002
Completamento primario (Effettivo)
1 giugno 2004
Completamento dello studio (Effettivo)
1 giugno 2004
Date di iscrizione allo studio
Primo inviato
11 febbraio 2013
Primo inviato che soddisfa i criteri di controllo qualità
11 febbraio 2013
Primo Inserito (Stima)
12 febbraio 2013
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
24 febbraio 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
23 febbraio 2015
Ultimo verificato
1 gennaio 2015
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2993-112E
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 .
Prove cliniche su AC2993
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