Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission
QUAZAR AML-001
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission
2 other identifiers
interventional
472
22 countries
210
Brief Summary
This study enrolled 472 participants, aged 55 or older, with a diagnosis of de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML), and who have achieved first complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) following induction with or without consolidation chemotherapy. The study is amended to include an extension phase (EP). The EP allows participants who are currently receiving oral azacitidine and who are demonstrating clinical benefit as assessed by the investigator, to continue receiving oral azacitidine after unblinding by sponsor until the participant meets the criteria for study discontinuation or until oral azacitidine becomes commercially available and reimbursed. In addition, all participants in the placebo arm and participants who had been discontinued from the treatment phase (irrespective of randomization arm) and continuing in the follow-up phase will be followed for survival in the EP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2013
Longer than P75 for phase_3
210 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2012
CompletedFirst Posted
Study publicly available on registry
December 31, 2012
CompletedStudy Start
First participant enrolled
April 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2019
CompletedResults Posted
Study results publicly available
November 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2024
CompletedJuly 8, 2025
June 1, 2025
6.2 years
November 21, 2012
September 29, 2020
June 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Kaplan-Meier (K-M) Estimate for Overall Survival (OS)
Overall survival was defined as time from randomization to death from any cause; participants surviving at the end of the follow-up period, or who withdraw consent, or who were lost to follow up were censored at the date last known alive.
Day 1 (randomization) up to data cut off date of 15 July 2019; median follow-up for OS estimated by the reverse K-M method was 41.2 months for all participants.
Secondary Outcomes (9)
Kaplan-Meier Estimate of Relapse Free Survival (RFS)
From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months
Kaplan-Meier Estimate of Time to Relapse
From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months
Kaplan-Meier Estimates of Time to Discontinuation From Treatment
From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months
Mean Change in the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue Scale V 4.0) Score From Baseline
From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months
- +4 more secondary outcomes
Study Arms (2)
Oral Azacitidine
EXPERIMENTAL300 mg oral azacitidine on days 1 to 14 of each 28-day treatment cycle.
Placebo
PLACEBO COMPARATORIdentically matching placebo tablets on days 1 to 14 of each 28-day treatment cycle.
Interventions
300 mg oral azacitidine on days 1 to 14 of each 28-day treatment cycle.
Identically matching placebo tablets on days 1 to 14 of each 28-day treatment cycle.
Eligibility Criteria
You may qualify if:
- Male or female participants ≥ 55 years of age
- Newly diagnosed, histologically confirmed de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or CMML (Chronic myelomonocytic leukemia)
- First complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) with induction therapy with intensive chemotherapy with or without consolidation therapy within 4 months (+/- 7 days of achieving CR or CRi)
- Eastern Cooperative Oncology Group (ECOG) performance status - 0, 1, 2, 3
- At the Investigator's discretion and with approval of the sponsor, participants meeting all of the following eligibility criteria are eligible to enter the extension phase:
- All participants randomized into the oral azacitidine or placebo arm and are continuing in either the treatment phase or follow-up phase of the CC-486-AML-001 study;
- Participants randomized to oral azacitidine treatment arm and continuing in the treatment phase demonstrating clinical benefit as assessed by the investigator are eligible to receive oral azacitidine in the extension phase (EP);
- Participants randomized into placebo arm of the study will not receive oral azacitidine in the EP, but will be followed for survival in the EP;
- Participants currently in the follow-up phase will continue to be followed for survival in the EP;
- Participants who have signed the informed consent for the EP of the study;
- Participants who do not meet any of the criteria for study discontinuation
You may not qualify if:
- AML with inversion (inv)(16), translocation = t(8;21), t(16;16), t(15;17), or t(9;22) or molecular evidence of such translocations
- Prior bone marrow or stem cell transplantation
- Have achieved CR/CRi following therapy with hypomethylating agents
- Diagnosis of malignant disease within the previous 12 months
- Proven central nervous system (CNS) leukemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (223)
Arizona Oncology Associates, P.C.
Phoenix, Arizona, 85016, United States
Providence St Joseph Medical Center Cancer Center
Burbank, California, 91505, United States
City Of Hope
Duarte, California, 91010-301, United States
University of California San Francisco Fresno Campus
Fresno, California, 93701, United States
University of Southern California Norris Cancer Center
Los Angeles, California, 90033, United States
Local Institution - 006
Los Angeles, California, 90095-6956, United States
Local Institution - 050
Orange, California, 92868, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
Stanford Cancer Center
Stanford, California, 94305, United States
Innovative Clinical Research Institute
Whittier, California, 90603, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218-1210, United States
Local Institution - 010
Southington, Connecticut, 06489, United States
George Washington University Cancer Center
Washington D.C., District of Columbia, 20037, United States
Local Institution - 046
Gainesville, Florida, 32610, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
Local Institution - 044
Orlando, Florida, 32806, United States
Northwestern University Medical Center
Chicago, Illinois, 60611, United States
Loyola University Chicago
Maywood, Illinois, 60153, United States
Cancer Care and Hematology Specialists of Chicagoland, P.C. - Niles, IL
Niles, Illinois, 60714, United States
Local Institution - 013
Indianapolis, Indiana, 46202-528, United States
Franciscan St. Francis Health
Indianapolis, Indiana, 46237, United States
Local Institution - 003
Westwood, Kansas, 66205, United States
Local Institution - 049
Louisville, Kentucky, 40202, United States
Local Institution - 058
Louisville, Kentucky, 40207, United States
Local Institution - 047
New Orleans, Louisiana, 70112, United States
Ochsner Medical Center - Jefferson Highway
New Orleans, Louisiana, 70121-2483, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Local Institution - 015
Worcester, Massachusetts, 01655, United States
Local Institution - 037
Rochester, Minnesota, 55905, United States
Local Institution - 023
Kansas City, Missouri, 64128, United States
Washington University School Of Medicine
St Louis, Missouri, 63110, United States
Local Institution - 057
Omaha, Nebraska, 68198-7680, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
Winthrop University Hospital
Mineola, New York, 11501-3893, United States
Local Institution - 009
New York, New York, 10029, United States
Columbia University Irving Medical Center
New York, New York, 10032, United States
Local Institution - 002
New York, New York, 10065, United States
Local Institution - 004
Rochester, New York, 14642, United States
Local Institution - 014
Valhalla, New York, 10595, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Local Institution - 025
Winston-Salem, North Carolina, 27157, United States
Local Institution - 016
Cleveland, Ohio, 44106, United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
Kaiser Permanente Northwest Oncology Hematology
Portland, Oregon, 97227, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17604, United States
UPMC Cancer Pavillion
Pittsburgh, Pennsylvania, 15232, United States
Greenville Hospital System
Greenville, South Carolina, 29605, United States
Local Institution - 011
Nashville, Tennessee, 37203, United States
Local Institution - 007
Nashville, Tennessee, 37232-5505, United States
Local Institution - 041
Dallas, Texas, 75390-9068, United States
Local Institution - 034
Fort Sam Houston, Texas, 78234, United States
Local Institution - 001
Houston, Texas, 77030, United States
Cancer Care Centers of South Texas - Loop
San Antonio, Texas, 78217, United States
Local Institution - 039
San Antonio, Texas, 78229, United States
Local Institution - 035
Richmond, Virginia, 23298-0037, United States
Swedish Cancer Inst
Seattle, Washington, 98104, United States
Yakima Valley Memorial Hospital/ North Star Lodge
Yakima, Washington, 98902, United States
Froedtert Hospital BMT Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3522, United States
Local Institution - 510
Wollongong, New South Wales, 2500, Australia
Local Institution - 509
South Brisbane, Queensland, 4101, Australia
Local Institution - 508
Adelaide, South Australia, SA 5000, Australia
Local Institution - 511
Bedford Park, South Australia, 5042, Australia
Local Institution - 504
Woodville South, South Australia, 5011, Australia
Local Institution - 503
Heidelberg, 3084, Australia
Local Institution - 502
Hobart, 7000, Australia
Local Institution - 507
Liverpool, 2170, Australia
Local Institution - 500
Melbourne, 3004, Australia
Local Institution - 505
Perth, 6000, Australia
Local Institution - 512
Perth, 6000, Australia
Local Institution - 506
St Leonards, 2065, Australia
Local Institution - 501
Woolloongabba, 4102, Australia
Local Institution - 271
Graz, 73013, Austria
Local Institution - 270
Salzburg, 5020, Austria
Local Institution - 274
Vienna, 1130, Austria
Local Institution - 272
Vienna, 1140, Austria
Local Institution - 273
Vienna, 1190, Austria
Local Institution - 300
Bruges, 8000, Belgium
Local Institution - 301
Charleroi, 6000, Belgium
Local Institution - 302
Mons, 7000, Belgium
Local Institution - 233
Curitiba, Paraná, 81520-060, Brazil
Local Institution - 231
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Local Institution - 232
Rio de Janeiro, 20230-130, Brazil
Local Institution - 234
São Paulo, 01308-050, Brazil
Local Institution - 230
São Paulo, 05651-901, Brazil
Local Institution - 605
Edmonton, Alberta, T6G 2B7, Canada
Local Institution - 600
Winnipeg, Manitoba, R3E OV9, Canada
Local Institution - 601
Saint John, New Brunswick, E2L 4L2, Canada
Local Institution - 603
St. John's, Newfoundland and Labrador, A1B3V6, Canada
Local Institution - 604
Halifax, Nova Scotia, B3H 2Y9, Canada
Local Institution - 607
Toronto, Ontario, M5G 2M9, Canada
Local Institution - 608
Montreal, Quebec, H2W 1S6, Canada
Local Institution - 602
Montreal, Quebec, H4J 1C5, Canada
Local Institution - 320
Brno, South Moravian, 625 00, Czechia
Local Institution - 321
Prague, 128 08, Czechia
Local Institution - 322
Prague, 128 20, Czechia
Local Institution - 361
Helsinki, 290, Finland
Local Institution - 362
Tampere, 33521, Finland
Local Institution - 360
Turku, 20521, Finland
Local Institution - 456
Amiens, 80054, France
Local Institution - 465
Argenteuil, 95100, France
Local Institution - 457
Bobigny, 93009, France
Local Institution - 462
Boulognes Sur Mer, 62200, France
Local Institution - 460
Clamart, 92141, France
Local Institution - 452
Créteil, 94010, France
Local Institution - 458
Le Chesnay, 78157, France
Local Institution - 453
Lille, 59037, France
Local Institution - 461
Limoges, 87042, France
Local Institution - 450
Lyon, 69437, France
Local Institution - 463
Paris, 75015, France
Local Institution - 454
Paris, 75475, France
Local Institution - 800
Paris, 75475, France
Local Institution - 464
Pontoise, 95301, France
Local Institution - 455
Rouen, 76038, France
Local Institution - 459
Saint-Cloud, 92210, France
Local Institution - 451
Villejuif, 94805, France
Local Institution - 400
Dresden, Saxony, 01307, Germany
Local Institution - 413
Berlin, 12203, Germany
Local Institution - 410
Bonn, 53127, Germany
Local Institution - 406
Düsseldorf, 40225, Germany
Local Institution - 415
Erlangen, 91054, Germany
Local Institution - 404
Frankfurt am Main, 65929, Germany
Local Institution - 412
Goch, 47574, Germany
Local Institution - 405
Hanover, 30625, Germany
Local Institution - 408
Heilbronn, 74078, Germany
Local Institution - 414
Jena, 07740, Germany
Local Institution - 403
Keil, 24105, Germany
Local Institution - 402
Mannheim, 68167, Germany
Local Institution - 409
München, 80804, Germany
Local Institution - 411
München, 81675, Germany
Local Institution - 407
Oldenburg, 26133, Germany
Local Institution - 416
Schweiler, 52249, Germany
Local Institution - 401
Ulm, 89081, Germany
Local Institution - 950
Dublin, 24, Ireland
Local Institution - 951
Galway, ST46QG, Ireland
Local Institution - 381
Beersheba, 84101, Israel
Local Institution - 380
Haifa, 35254, Israel
Local Institution - 383
Jerusalem, 91120, Israel
Local Institution - 382
Petah Tikva, 49100, Israel
Local Institution - 701
Alessandria, 15121, Italy
Local Institution - 721
Bari, 70124, Italy
Local Institution - 720
Bologna, 40138, Italy
Local Institution - 710
Cagliari, O9126, Italy
Local Institution - 702
Cremona, 26100, Italy
Local Institution - 708
Florence, 50129, Italy
Local Institution - 712
Genova, 16132, Italy
Local Institution - 716
Lecce, 73100, Italy
Local Institution - 706
Milan, 20122, Italy
Local Institution - 726
Milan, 20162, Italy
Local Institution - 704
Monza, 20900, Italy
Local Institution - 717
Naples, 80131, Italy
Local Institution - 725
Naples, 80131, Italy
Local Institution - 705
Orbassano (TO), 10043, Italy
Local Institution - 703
Palermo, 90146, Italy
Local Institution - 719
Palermo, 90146, Italy
Local Institution - 724
Pesaro, 31122, Italy
Local Institution - 700
Reggio Calabria, 89100, Italy
Local Institution - 709
Roma, 00161, Italy
Local Institution - 714
Roma, 00168, Italy
Local Institution - 723
Roma, 00189, Italy
Local Institution - 722
Rome, 133, Italy
Local Institution - 715
Torino, 10126, Italy
Local Institution - 718
Torino, 10126, Italy
Local Institution - 711
Udine, 33100, Italy
Local Institution - 707
Varese, 21100, Italy
Local Institution - 750
Klaipėda, 5809, Lithuania
Local Institution - 252
Huixquilucan de Degollado, 52763, Mexico
Local Institution - 251
México, 14080, Mexico
Local Institution - 250
Monterrey, 64460, Mexico
Local Institution - 824
Bydgoszcz, 85-168, Poland
Local Institution - 820
Gdansk, 80-211, Poland
Local Institution - 822
Lodz, 93-510, Poland
Local Institution - 821
Warsaw, 02-776, Poland
Local Institution - 823
Wroclaw, 50-367, Poland
Local Institution - 841
Coimbra, 4200-072, Portugal
Local Institution - 840
Lisbon, 1099-023, Portugal
Local Institution - 843
Lisbon, 1150-314, Portugal
Local Institution - 842
Porto, 4200-072, Portugal
Local Institution - 844
Porto, 4200, Portugal
Local Institution - 971
Moscow, 125101, Russia
Local Institution - 970
Nizhny Novgorod, 603005, Russia
Local Institution - 972
Saint Petersburg, 196022, Russia
Local Institution - 973
Saint Petersburg, 197341, Russia
Local Institution - 535
Busan, 49241, South Korea
Local Institution - 533
Daegu, 700-721, South Korea
Local Institution - 536
Seoul, 120-752, South Korea
Local Institution - 530
Seoul, 135-710, South Korea
Local Institution - 531
Seoul, 137-701, South Korea
Local Institution - 532
Seoul, 138-736, South Korea
Local Institution - 872
Palma de Mallorca, Balearic Islands, 07198, Spain
Local Institution - 867
A Coruña, 15006, Spain
Local Institution - 869
Badalona (Barcelona), 8916, Spain
Local Institution - 871
Barcelona, 08025, Spain
Local Institution - 870
Barcelona, 08035, Spain
Local Institution - 873
Cáceres, 10003, Spain
Local Institution - 863
Córdoba, 14004, Spain
Local Institution - 868
Madrid, 28006, Spain
Local Institution - 866
Madrid, 28007, Spain
Local Institution - 865
Madrid, 28040, Spain
Local Institution - 864
Oviedo, 33006, Spain
Local Institution - 861
Salamanca, 37007, Spain
Local Institution - 862
Seville, 41013, Spain
Local Institution - 860
Valencia, 46026, Spain
Local Institution - 599
Beitou District, Taipei City, 11217, Taiwan
Local Institution - 595
Niaosong District Kaohsiung City, 83301, Taiwan
Local Institution - 596
Taichung, Northern Dist., 404, Taiwan
Local Institution - 597
Tainan, Taiana, 704, Taiwan
Local Institution - 598
Taipei, Zhongzheng Dist., 10002, Taiwan
Local Institution - 653
Ankara, 06100, Turkey (Türkiye)
Local Institution - 650
Ankara, 06200, Turkey (Türkiye)
Local Institution - 651
Istanbul, 34662, Turkey (Türkiye)
Local Institution - 652
Samsun, 55139, Turkey (Türkiye)
Local Institution - 904
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Local Institution - 907
Boston, PE21 9QS, United Kingdom
Local Institution - 903
Brighton East Sussex, BN2 5BE, United Kingdom
Local Institution - 902
Canterbury Kent, CT1 3NG, United Kingdom
Local Institution - 905
London, NW1 2PG, United Kingdom
Local Institution - 901
London, SE5 9RS, United Kingdom
Local Institution - 908
London, W12 0HS, United Kingdom
Local Institution - 909
Maidstone, ME16 9QQ, United Kingdom
Local Institution - 900
Manchester, M20 4BX, United Kingdom
Local Institution - 906
Romford, Essex, RM7 0AG, United Kingdom
Related Publications (8)
Roboz GJ, Montesinos P, Selleslag D, Wei A, Jang JH, Falantes J, Voso MT, Sayar H, Porkka K, Marlton P, Almeida A, Mohan S, Ravandi F, Garcia-Manero G, Skikne B, Kantarjian H. Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia. Future Oncol. 2016 Feb;12(3):293-302. doi: 10.2217/fon.15.326. Epub 2016 Jan 19.
PMID: 26785287BACKGROUNDRavandi F, Dohner H, Wei AH, Montesinos P, Pfeilstocker M, Papayannidis C, Lai Y, Wang K, See WL, de Menezes DL, Petrlik E, Prebet T, Roboz GJ. Survival outcomes in patients with acute myeloid leukaemia who received subsequent therapy for relapse in QUAZAR AML-001. Br J Haematol. 2024 Mar;204(3):877-886. doi: 10.1111/bjh.19202. Epub 2023 Nov 12.
PMID: 37952982DERIVEDWei AH, Roboz GJ, Dombret H, Dohner H, Schuh AC, Montesinos P, Selleslag D, Bondarenko SN, Prebet T, Lai Y, Skikne B, Beach CL, Ravandi F. Survival outcomes with oral azacitidine maintenance in patients with acute myeloid leukemia in remission by receipt of initial chemotherapy: subgroup analyses from the phase III QUAZAR AML-001 trial. Haematologica. 2023 Oct 1;108(10):2820-2825. doi: 10.3324/haematol.2022.282296. No abstract available.
PMID: 36951156DERIVEDDohner H, Wei AH, Roboz GJ, Montesinos P, Thol FR, Ravandi F, Dombret H, Porkka K, Sandhu I, Skikne B, See WL, Ugidos M, Risueno A, Chan ET, Thakurta A, Beach CL, Lopes de Menezes D. Prognostic impact of NPM1 and FLT3 mutations in patients with AML in first remission treated with oral azacitidine. Blood. 2022 Oct 13;140(15):1674-1685. doi: 10.1182/blood.2022016293.
PMID: 35960871DERIVEDZhu J, Wu Q, Wang J, Niu T. Cost-effectiveness analysis of azacitidine maintenance therapy in patients with acute myeloid leukemia. Expert Rev Hematol. 2022 Apr;15(4):375-382. doi: 10.1080/17474086.2022.2061456. Epub 2022 May 11.
PMID: 35437111DERIVEDRoboz GJ, Ravandi F, Wei AH, Dombret H, Thol F, Voso MT, Schuh AC, Porkka K, La Torre I, Skikne B, Zhong J, Beach CL, Risueno A, Menezes DL, Ossenkoppele G, Dohner H. Oral azacitidine prolongs survival of patients with AML in remission independently of measurable residual disease status. Blood. 2022 Apr 7;139(14):2145-2155. doi: 10.1182/blood.2021013404.
PMID: 34995344DERIVEDRavandi F, Roboz GJ, Wei AH, Dohner H, Pocock C, Selleslag D, Montesinos P, Sayar H, Musso M, Figuera-Alvarez A, Safah H, Tse W, Sohn SK, Hiwase D, Chevassut T, Pierdomenico F, La Torre I, Skikne B, Bailey R, Zhong J, Beach CL, Dombret H. Management of adverse events in patients with acute myeloid leukemia in remission receiving oral azacitidine: experience from the phase 3 randomized QUAZAR AML-001 trial. J Hematol Oncol. 2021 Aug 28;14(1):133. doi: 10.1186/s13045-021-01142-x.
PMID: 34454540DERIVEDWei AH, Dohner H, Pocock C, Montesinos P, Afanasyev B, Dombret H, Ravandi F, Sayar H, Jang JH, Porkka K, Selleslag D, Sandhu I, Turgut M, Giai V, Ofran Y, Kizil Cakar M, Botelho de Sousa A, Rybka J, Frairia C, Borin L, Beltrami G, Cermak J, Ossenkoppele GJ, La Torre I, Skikne B, Kumar K, Dong Q, Beach CL, Roboz GJ; QUAZAR AML-001 Trial Investigators. Oral Azacitidine Maintenance Therapy for Acute Myeloid Leukemia in First Remission. N Engl J Med. 2020 Dec 24;383(26):2526-2537. doi: 10.1056/NEJMoa2004444.
PMID: 33369355DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2012
First Posted
December 31, 2012
Study Start
April 24, 2013
Primary Completion
July 15, 2019
Study Completion
June 18, 2024
Last Updated
July 8, 2025
Results First Posted
November 6, 2020
Record last verified: 2025-06