Study of VELCADE and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
A Randomized, Open-Label, Multicenter Study of VELCADE With Rituximab or Rituximab Alone in Subjects With Relapsed or Refractory, Rituximab Naive or Sensitive Follicular B-cell Non-Hodgkin's Lymphoma
1 other identifier
interventional
676
32 countries
206
Brief Summary
The purpose of this study is to determine if the combination of VELCADE and rituximab improves progression free survival relative to rituximab alone in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (B-NHL) who never received rituximab or who have previously responded to rituximab. This is an international study being conducted in the United States and in many countries around the world. A complete list of study locations is listed below.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2006
Typical duration for phase_3
206 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
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 7, 2006
CompletedFirst Posted
Study publicly available on registry
April 11, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
July 26, 2011
CompletedJune 25, 2012
June 1, 2012
4.3 years
April 7, 2006
June 29, 2011
June 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
Progression free survival is defined as time from randomization to progressive disease or death due to any cause, whichever occurs first.
Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.
Secondary Outcomes (1)
Overall Response Rate
Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.
Study Arms (2)
Bortezomib + Rituximab
EXPERIMENTALRituximab
ACTIVE COMPARATORInterventions
VELCADE for Injection will be administered weekly on Days 1,8,15, and 22 of a 35-day cycle in combination with 4 doses of rituximab once a week on Days 1,8,15, and 22 of Cycle 1 and in combination with a single dose of rituximab on Day 1 of Cycles 2 to 5.
rituximab once a week on Days 1,8,15, and 22 of Cycle 1, and as a single dose on Day 1 of Cycles 2 to 5 (for a total of 8 doses).
Eligibility Criteria
You may qualify if:
- Subjects must satisfy the following criteria to be enrolled in the study:
- Man or woman and age 18 years or older
- Diagnosis of follicular B-NHL of the following subtypes (World Health Organization \[WHO\] classification 1997): follicular lymphoma (FL) (Grades 1 and 2).
- Documented relapse or progression following prior antineoplastic treatment. New lesions or objective evidence of progression of existing lesions must document relapse or progression following the previous therapy.
- If any prior regimen included rituximab, the subject must have responded (complete response \[CR\], unconfirmed complete response \[CRu\], partial response \[PR\]), and the time to progression (TTP) from the first dose of rituximab must have been 6 months or more.
- At least 1 measurable tumor mass (greater than 1.5 cm in the longest dimension and greater than 1.0 cm in the short axis) that has not been previously irradiated, or has grown since previous irradiation
- In the opinion of the investigator the decision to initiate treatment is justified to manage the subject's lymphoma
- No active central nervous system lymphoma
- Eastern Cooperative Oncology Group \[ECOG\] status ≤ 2
- Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at screening.
- Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- In countries where health authorities have approved the pharmacogenomic testing, subjects or their legally acceptable representatives must have signed a separate informed consent that they agree to participate in the genetic part and protein testing part of the study; participation in the genetic and protein testing component is mandatory for pharmacogenomics testing, but optional for serum protein testing and future testing.
You may not qualify if:
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Diagnosed or treated for a malignancy other than NHL within 1 year of randomization, or who were previously diagnosed with a malignancy other than NHL and have any radiographic or biochemical marker evidence of malignancy. Subjects with completely resected basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy are not excluded.
- Clinical evidence of a transformation from indolent NHL to a more aggressive form of NHL.
- History of disallowed therapies:
- Prior treatment with VELCADE
- Antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization
- Nitrosoureas within 6 weeks before randomization
- Radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization
- Stem cell transplant within 6 months before randomization
- Major surgery within 2 weeks before randomization
- Residual toxic effects of previous therapy or surgery of Grade 3 or worse
- Peripheral neuropathy or neuropathic pain of Grade 2 or worse
- Have received an experimental drug or used an experimental medical device within 21 days before the planned start of treatment.
- History of allergic reaction attributable to compounds containing boron or mannitol
- Known anaphylaxis or immunoglobulin E (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab including polysorbate 80 and sodium citrate dihydrate
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (206)
East Alabama Medical Center
Opelika, Alabama, United States
Central Hematology Oncology Medical Group, Inc
Alhambra, California, 91801, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
Providence Saint Joseph Medical Center
Burbank, California, 91505, United States
St. Jude Heritage Medical Group
Fullerton, California, 92835, United States
Wilshire Oncology Medical Group, Inc.
La Verne, California, 91790, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
University of Southern California
Los Angeles, California, 90033, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
North Valley Hematology Oncology
Mission Hills, California, 91345, United States
University of California, Irvine Medical Center
Orange, California, 92868, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030, United States
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, 90277, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454, United States
Norwalk Medical Group
Norwalk, Connecticut, United States
Hematology Oncology PC
Stamford, Connecticut, United States
Integrated Community Oncology Network
Jacksonville, Florida, United States
Innovative Clinical Research of South Florida
Miami, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Emory Univeersity ,Winship Cancer Institute
Atlanta, Georgia, United States
Suburban Hematology-Oncology Associates
Lawrenceville, Georgia, 30045, United States
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, 30060, United States
North Idaho Cancer Center
Coeur d'Alene, Idaho, United States
Investigative Clinical Research of Indiana
Indianapolis, Indiana, United States
Siouxland Hematolgoy-Oncology Associates
Sioux City, Iowa, United States
Kansas City Cancer Center, LLC
Kansas City, Kansas, 66210, United States
Louisville Oncology
Louisville, Kentucky, United States
Hematology & Oncology Specialists
Metairie, Louisiana, United States
Sinai Hospital
Baltimore, Maryland, United States
Hattiesburg Clinic
Hattesburg, Missouri, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27530, United States
Oregon Health & Science University
Portland, Oregon, United States
Lancaster Cancer Center, Ltd.
Lancaster, Pennsylvania, 17601, United States
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
South Carolina Oncology Associates, PA
Columbia, South Carolina, 29210, United States
South Carolina Oncology Associates
Columbia, South Carolina, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
Oncology Consultants
Houston, Texas, 777024, United States
South Texas Oncology and Hematology
San Antonio, Texas, United States
Medical College of Wisconsin Milwaukee
Milwaukee, Wisconsin, United States
Higa San Martin
La Plata - Buenos Aires, Argentina
Hospital Professor Rodolfo Rossi
La Plata - Buenos Aires, Argentina
Centro Oncologico Integracion Regional
Mendoza, Argentina
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Peter MacCallum Cancer Institute
East Melbourne, Victoria, 3002, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Fremantle Hospital
Fremantle, Western Australia, 6160, Australia
ULB Erasme
Anderlecht, 1070, Belgium
AZ Stuivenberg
Antwerp, 2060, Belgium
AZ Sint Jan
Bruges, 8000, Belgium
Institute J. Bordet
Brussels, 1000, Belgium
Clinique Notre Dame
Charleroi, 6000, Belgium
UZ Antwerpen - Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
UZ Gent - Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Virga Jesse Ziekenhuis, Dienst Hematologie
Hasselt, 3500, Belgium
CHR La Citadelle
Liège, 4000, Belgium
CHU Sart Tilman
Liège, 4000, Belgium
Heilig Hart Roeselare
Roeselare, 8800, Belgium
Servico de Oncologia do Hospital Sao Lucas da PUC do rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90610-00, Brazil
Instituto Nacional de Cancer
Rio de Janeiro, 20231-050, Brazil
Hospital Brigadeiro
SĂ£o Paulo, 01404-901, Brazil
Faculdade de Medicina do ABC
SĂ£o Paulo, 09060-650, Brazil
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
University Health Network - Princess Margaret Hospital
Toronto, Ontario, Canada
Juravinski Cancer Centre
Hamilton, Canada
West China Hospital of Sichuan
Chengdu, Sichuan, 610041, China
Cancer Hospital (Institute), CAMS&PUMC
Beijing, 100021, China
Beijing Cancer Hospital
Beijing, 100036, China
Peking University People's Hospital
Beijing, 100044, China
Affiliated Hospital of the Academy of Military Medical Sciences
Beijing, 100071, China
Cancer Center, Sun Yat-Sen University
Guangzhou, 510060, China
Peking University Third Hospital
Haidian District Beijing, 100083, China
RuiJin Hospital
Shanghai, 200025, China
Cancer Hospital - FuDan University
Shanghai, 200032, China
Bank of Cyprus Oncology Centre
Nicosia, 2006, Cyprus
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Fakultni nemocnice Hradec Kralove
Hradec KrĂ¡lovĂ©, 500 05, Czechia
Fakultni nemocnice Olomouc
Olomouc, 775 20, Czechia
Vseobecna Fakultni Nemocnice
Prague, 2, Czechia
Paijat - Hameen Keskussairaala
Lahti, 15850, Finland
Satakunnan Keskussairaala
Pori, 28500, Finland
Institut Bergonie
Bordeaux, 33076, France
Clinique Victor Hugo
Le Mans, 72015, France
Hopital Claude Huriez
Lille, 59037, France
Centre LĂ©on BĂ©rard
Lyon, 69373, France
Hopital Hotel Dieu
Nantes, 44098, France
Service des Maladies due sang - Hopital haut Leveque
Pessac, 33604, France
Centre Hospitalier Lyon Sud
Pierre-BĂ©nite, 69495, France
Onkologische Schwerpunktpraxis
Herrsching am Ammersee, 82211, Germany
Universitatsklinikum Munster - Klinik fur Innere Medizin
MĂ¼nster, Germany
Praxis fĂ¼r Hämetologie und Oncologie
WĂ¼rzburg, 97070, Germany
Laiko General Hospital of Athens - 1st Internist Clinic - Hematology Department
Athens, 11527, Greece
University General Hospital Attikon - 2nd Department of Internal Medicine - Propedeutic & Research Institute
Athens, 12462, Greece
University Hospital of Patras - Department of Internal Medicine - Hematology Division
Rio Patras, 26500, Greece
Debreceni Egyetem, Orvos- es Egeszsegtudomanyl Centrum, iii. Belgyogyaszati Klinika
Debrecen, H-4004, Hungary
Petz Aladar County Hospital
Győr, 9024, Hungary
SZEgedi Tudomanyegyetem, II Belgyaszati Klinika
Szeged, H-6720, Hungary
Institution Manipal Hospital
Bangalore, India
Postgraduate Institute of Medical Education and Research
Chandigarh, 160 012, India
Apollo Speciality Hospital
Chennai, 6000035, India
Nizam's Institute of Medical Sciences
Hyderabaad, 500 082, India
SMS Medical College Hospital
Jaipur, 302 004, India
Apollo Hospitals, Hyderabad Apollo Hospital Complex
Jubilee Hills, India
Shirdi Saibaba Cancer Hospital
Karnataka, 576 104, India
Department of Medical Oncology - Regional Cancer Centre
Kerala, India
Regional Cancer Centre
Kerala, India
Tata Memorial Centre
Mumbai, 400 012, India
Soroka Medical Center
Beersheba, Israel
Rambam Medical Center
Haifa, Israel
Hadassah Medical Center
Jerusalem, Israel
Rabin Medical Center
Petah Tikva, Israel
Sorraski Tel Aviv Medical Center
Tel Aviv, Israel
Sheba Medical Center
Tel Litwinsky, Israel
Azienda Ospedaliero Universitaria di Bologna
Bologna, 40138, Italy
Universita degli Studi di Perugia
Perugia, 06122, Italy
Azienda Ospedallera Universitaria Policlinico Tor Vergata
Roma, 00133, Italy
Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
Torino, 10126, Italy
Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran
Delagacion Tlalpan, 14000, Mexico
Instituto Nacional De Cancerologia Incan
Delagacion Tlalpan, 14080, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez UANL
Monterrey, Nuevo Leon, 64460, Mexico
Canterbury Health Laboratories
Christchurch, New Zealand
Klinika Hematologii Instytut Chorob Wewnetrznych
Gdansk, 80-952, Poland
Klinika Hematologii CMUJ
Krakow, 31-501, Poland
Klinika Hematologii - Uniwersytetu Medycznego
Lodz, 93-510, Poland
Klinika Hematologii i Transplantologii Szpiku AM
Lublin, 20-081, Poland
Wojskowy Instytut Medyczny - Klinika Hematologii
Warsaw, 00-909, Poland
Instytut Hematologii i Transfuzjologii
Warsaw, 00-957, Poland
Klinika Hematologii AM
Warsaw, 02-097, Poland
Klinika Nowotworow Ukladu Chlonnego
Warsaw, 02-781, Poland
Katedra i Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku
Wroclaw, 50-367, Poland
Servico de Hematologia - Hospital de Dia - Hospital Da Universidade de Coimbra
Coimbra, 3000-075, Portugal
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. - Departmento de Hematologia
Lisbon, 1099-023, Portugal
Hospital de Dia de Hematologia - Hospital de Santa Maria E.P.E.
Lisbon, 1649-035, Portugal
Serviço de Onco-hematologia, Instituto PortuguĂªs de Oncologia do Porto Franscisco Gentil, EPE
Porto, 4200-072, Portugal
San Juan VA Medical Center
San Juan, 00921, Puerto Rico
Spitalul clinic de urgenta
Brasov, Romania
Institutul Clinic Fundeni Clinica de Hematologie
Bucharest, Romania
Spitalul Universitar de Urgenta Hematologie
Bucharest, Romania
Spitalul Clinic judetean de urgenta "Sf. Spiridon, Clinica Hematologie
Iași, Romania
Spitalul Clinic judetean de urgenta Mures
TĂ¢rgu MureÅŸ, Romania
Arkhangelsk Region Clinical Hospital
Arghangelsk, 163045, Russia
Altay Regional Oncology Dispensary
Barnaul, 656049, Russia
Belgorod Regional Oncology Center
Belgorod, 308010, Russia
Cheliabinsk Regional Oncology Dispensary
Chelyabinsk, 454087, Russia
1st Republican Clinical Hospital of Udmurtia
Izhevsk, 426039, Russia
Cancer Research Center
Moscow, 115478, Russia
S.P. Botkin Moscow City Clinical Hospital
Moscow, 125101, Russia
Moscow Region Clinical Research Institute
Moscow, 129110, Russia
Semashko Central Clinical Hospital #2
Moscow, 129128, Russia
City Oncology Hospital #62
Moscow, 143423, Russia
Nizhniy Novgorod Region Clinical Hospital
Nizhny Novgorod, 603129, Russia
Novosibirsk State Regional Clinical Hospital
Novosibirsk, 630087, Russia
Novosibirsk State Medical University
Novosibirsk, 630091, Russia
Medical Scientifical Radiology Center
Obninsk, 249020, Russia
Republikan Hospital named after V.A. Baranov
Petrozavodsk, 185019, Russia
St. Petersburg Clinical Research Institute of Hematology and Transfusiology
Saint Petersburg, 191024, Russia
Saint Petersburg Pavlov State Medical University
Saint Petersburg, 197022, Russia
St. Petersburg City Hospital #31
Saint Petersburg, 197110, Russia
Saratov State Medical University
Saratov, 410028, Russia
Tomsk Research Oncology Institute
Tomsk, 634028, Russia
Republican Clinical Hospital of Bashkorkostan
Ufa, 450005, Russia
Ekaterinburg City Clinical Hospital #7
Yekaterinburg, 620137, Russia
FN F.D. Roosevelt - Oddelenie hematologie
Banska Bysterica, 97517, Slovakia
Fakultna nemocnica L. Pasteura - Klinika hematologie a onkohematologie
Košice, 040 11, Slovakia
Vychodoslovensky Onkologicky Ustave, a.s.
Košice, 041 90, Slovakia
Martinska FN, Klinika hematologie a transfuziologie
Martin, 036 59, Slovakia
GVI Oncology Clinical Trial Unit
Panorama, Cape Town, South Africa
Mary Potter Oncology Centre - Little Company of Mary Hospital
Groenkloof, Pretoria, 0181, South Africa
Chris Hani Baragwanath Hospital
Johannesburg, South Africa
East Cape Oncology Centre - St. Georges Hospital
Port Elizabeth, South Africa
Lung Cancer Center - National Cancer Center
Gyeonggi-do, 411-769, South Korea
Samsung Medical Center - Division of Hematology-Oncology, Department of Medicine
Ilmon-Dong, Kangnam-Ku, Seoul, 135-710, South Korea
Hematology-Oncology Clinic, Center for Specific Organs Cancer - National Cancer Center
Ilsandong-Gu, Goyang-Si, and Gyeonggi-Do, 410-769, South Korea
Samsung Medical Center - Department of Internal Medicine
Ilwon Dong, Kangnam-Ku, Seoul, 135-710, South Korea
Severance Hospital, Yonsei University College of Medicine
Seoul, 120-752, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Hospital Durans I Reynals - Institut Catala d'Oncologia
Barcelona, 08907, Spain
Hospital Germans Trias i Pujol Institut Catala d'Oncologia
Barcelona, 08916, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Onkologiska kliniken Universitetssjukhuset
Lund, Sweden
Centrum for Hematologi Karolinska University Hospital
Stockholm, Sweden
Hematologiska kliniken M54 Karolinska University Hospital
Stockholm, Sweden
King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
Ramathibodi Hospital, Mahidol University
Bangkok, 10400, Thailand
Siriraj Hospital, Mahidol University
Bangkok, 10700, Thailand
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
Chiang Mai, 50200, Thailand
Cherkassy Regional Oncology Dispensary
Cherkassy, 18009, Ukraine
Dnepropetrovsk Regional Clinical Oncology Dispensary
Dnipro, 46055, Ukraine
Institute for Emergency and Urgent Medical Assistance named after V.K. Gusak of AMS of Ukraine
Donetsk, 83045, Ukraine
Khmelnitskiy Regional Hopsital
Khmelnitsky, 29000, Ukraine
Kiev Center of Marrow Transplantaion
Kiev, 03115, Ukraine
Krivoy Rog Oncology Dispensary
Kryvyi Rih, Ukraine
Institute of Blood Pathology and Transfusional Medicine of AMS of Ukraine, Lviv Clinical Hospital #5
Lviv, 79044, Ukraine
Ukrainian Medical Stomatological Academy, Poltava Regional Dispensary
Poltava, 36024, Ukraine
Crimean Republic Clinical Oncology Dispensary
Simferopol, Ukraine
Zhitomir Gerbachevsky Regional Clinical Hospital
Zhytomyr, 10002, Ukraine
Aberdeen Royal Infirmary - Department of Haematology
Aberdeen, United Kingdom
Addenbrooke's Hospital - Department of Haematology
Cambridge, CB2 2QQ, United Kingdom
University Hospital of Wales
Cardiff, CF14 4XN, United Kingdom
Guy's & St. Thomas Hospital
London, SE1 9RT, United Kingdom
Derriford Hospital - Department of Haematology
Plymouth, PL6 8DH, United Kingdom
Taunton & Somerset Hospital
Taunton, TA1 5DA, United Kingdom
Related Publications (2)
Zinzani PL, Khuageva NK, Wang H, Garicochea B, Walewski J, Van Hoof A, Soubeyran P, Caballero D, Buckstein R, Esseltine DL, Theocharous P, Enny C, Zhu E, Elsayed YA, Coiffier B. Bortezomib plus rituximab versus rituximab in patients with high-risk, relapsed, rituximab-naive or rituximab-sensitive follicular lymphoma: subgroup analysis of a randomized phase 3 trial. J Hematol Oncol. 2012 Oct 22;5:67. doi: 10.1186/1756-8722-5-67.
PMID: 23088650DERIVEDCoiffier B, Osmanov EA, Hong X, Scheliga A, Mayer J, Offner F, Rule S, Teixeira A, Walewski J, de Vos S, Crump M, Shpilberg O, Esseltine DL, Zhu E, Enny C, Theocharous P, van de Velde H, Elsayed YA, Zinzani PL; LYM-3001 study investigators. Bortezomib plus rituximab versus rituximab alone in patients with relapsed, rituximab-naive or rituximab-sensitive, follicular lymphoma: a randomised phase 3 trial. Lancet Oncol. 2011 Aug;12(8):773-84. doi: 10.1016/S1470-2045(11)70150-4. Epub 2011 Jul 1.
PMID: 21724462DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Yusri A. Elsayed, M.D., M.H.Sc., Ph.D.
- Organization
- Johnson & Johnson Pharmaceutical Research & Development
Study Officials
- STUDY DIRECTOR
Medical Monitor
Millennium Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2006
First Posted
April 11, 2006
Study Start
March 1, 2006
Primary Completion
June 1, 2010
Study Completion
July 1, 2010
Last Updated
June 25, 2012
Results First Posted
July 26, 2011
Record last verified: 2012-06