A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia
An Open-label, Multi-center Study to Document the Efficacy, Safety, and Tolerability of Long-term Administration of RO0503821 in Patients With Chronic Renal Anemia
1 other identifier
interventional
1,228
26 countries
248
Brief Summary
This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia. Eligible patients were those who were receiving stable maintenance therapy with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (ESAs) in Phase II or III clinical studies. They continued to receive methoxy polyethylene glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of administration (sc or iv) as in the qualifying studies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2004
Longer than P75 for phase_3
248 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2004
CompletedFirst Posted
Study publicly available on registry
September 6, 2004
CompletedStudy Start
First participant enrolled
October 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
January 5, 2012
CompletedFebruary 14, 2012
February 1, 2012
5.2 years
September 3, 2004
December 1, 2011
February 10, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation
Blood samples were collected at each study visit, that is, every 4 weeks for the first 12 weeks, every 12 weeks until week 105 of the first study period, every 3 months thereafter, and at the end of study or the last visit if the patient discontinued the study prematurely.
Baseline to the end of the study (Up to 49 Months)
Secondary Outcomes (1)
Percentage of Patients Who Had at Least 1 Adverse Event
From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)
Study Arms (2)
Methoxy Polyethylene Glycol-Epoetin Beta
EXPERIMENTALPatients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
Comparator ESA
ACTIVE COMPARATORPatients received the same comparator ESA \[epoetin alfa, epoetin beta, or darbepoetin alfa\] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
Interventions
Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in 2-mL glass vials containing 1 mL solution or in single-use sterile pre-filled syringes (PFSs) containing 0.3 mL or 0.6 mL injectable solution. The injectable solution was available in vials with the following strengths: 50, 100, 200, 400, and 1000 μg/mL. The injectable solution was available in PFSs with the following strengths: 30, 40, 50, 60, 75, 100, 120, 150, 200, and 250 μg/0.3 mL; and 360 and 400 μg/0.6 mL.
Epoetin alfa was provided with commercial packaging in English with country-specific labels (10,000 IU, 20,000 IU).
Epoetin beta was provided with commercial packaging in English with country-specific labels (50,000 IU, 100,000 IU).
Darbepoetin alfa was provided with commercial packaging in English with country-specific labels (vials and PFSs in various strengths).
Eligibility Criteria
You may qualify if:
- Written informed consent
- Adult patients (≥ 18 years old) with chronic renal anemia
- Maintenance erythropoietic therapy with methoxy polyethylene glycol-epoetin beta or a protocol-specified reference medication (epoetin alfa formulated with human albumin, epoetin beta or darbepoetin alfa) in one of the following studies: BA16528\[NCT00048048\], BA16285\[NCT00048035\], BA16286\[NCT00364832\], BA16736\[NCT00077597\], BA16738\[NCT00081471\], BA16739\[NCT00077610\], BA16740\[NCT00077623\], BA17283\[NCT00077766\] and BA17284\[NCT00081484\]
- Hemoglobin (Hb) concentration between 10.5 and 13.0 g/dL
- Adequate iron status defined as serum ferritin ≥ 100 ng/mL or Transferrin Saturation (TSAT)≥ 20% or percentage of hypochromic red blood cells (RBCs) \< 10%
You may not qualify if:
- Poorly controlled hypertension
- History of epileptic seizure
- Pure red cell aplasia
- Chronic congestive heart failure \[New York Heart Association (NYHA) IV\]
- High likelihood of early withdrawal or interruption of the study
- Active malignant disease (except non-melanoma skin cancer)
- Life expectancy less than 12 months
- Pregnancy or breast-feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (249)
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Birmingham, Alabama, 35211, United States
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Mobile, Alabama, 36608, United States
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Montgomery, Alabama, 36106, United States
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Hot Springs, Arkansas, 71901, United States
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Covina, California, 91723, United States
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Encino, California, 91356, United States
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Irvine, California, 92868, United States
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Los Alamitos, California, 90720, United States
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Los Angeles, California, 90073, United States
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Los Angeles, California, 90095, United States
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Monterey Park, California, 91754, United States
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Mountain View, California, 94040, United States
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Sacramento, California, 95816-5119, United States
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San Diego, California, 92120, United States
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San Diego, California, 92123, United States
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San Francisco, California, 94117, United States
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Stanford, California, 94305, United States
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Colorado Springs, Colorado, 80909, United States
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Denver, Colorado, 80262, United States
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Lakewood, Colorado, 80260, United States
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Stamford, Connecticut, 06902, United States
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Ocala, Florida, 34471, United States
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Pembroke Pines, Florida, 33028, United States
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Atlanta, Georgia, 30342, United States
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Augusta, Georgia, 30309, United States
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Honolulu, Hawaii, 96813, United States
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Maywood, Illinois, 60153, United States
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South Holland, Illinois, 60473, United States
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Louisville, Kentucky, 40202-1718, United States
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Baton Rouge, Louisiana, 70884, United States
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Shreveport, Louisiana, 71101, United States
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Boston, Massachusetts, 02115, United States
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Boston, Massachusetts, 02135, United States
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Springfield, Massachusetts, 01107, United States
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Detroit, Michigan, 48202-2689, United States
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Detroit, Michigan, 48236, United States
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Kalamazoo, Michigan, 49007, United States
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Brooklyn Center, Minnesota, 55430, United States
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Columbus, Mississippi, 39705, United States
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Tupelo, Mississippi, 38801, United States
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St Louis, Missouri, 63110, United States
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Hackensack, New Jersey, 07601, United States
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Paterson, New Jersey, 07503, United States
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Albuquerque, New Mexico, 87131, United States
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Brooklyn, New York, 11203, United States
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Flushing, New York, 11355, United States
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Great Neck, New York, 11021, United States
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Mineola, New York, 11501, United States
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New York, New York, 10021, United States
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New York, New York, 10128, United States
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Orchard Park, New York, 14127, United States
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The Bronx, New York, 10467, United States
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Chapel Hill, North Carolina, 27599-7155, United States
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Mount Airy, North Carolina, 27030, United States
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Raleigh, North Carolina, 27609, United States
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Cincinnati, Ohio, 45267-0585, United States
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Cleveland, Ohio, 44109, United States
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Toledo, Ohio, 43606, United States
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Oregon City, Oregon, 97045, United States
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Portland, Oregon, 97201-2940, United States
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Portland, Oregon, 97210, United States
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Allentown, Pennsylvania, 18103, United States
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Erie, Pennsylvania, 16502, United States
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Lewistown, Pennsylvania, 17044, United States
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Philadelphia, Pennsylvania, 19106, United States
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Philadelphia, Pennsylvania, 19140, United States
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Philadelphia, Pennsylvania, 19141, United States
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Pittsburgh, Pennsylvania, 15224, United States
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Columbia, South Carolina, 29209, United States
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Orangeburg, South Carolina, 29118, United States
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Chattanooga, Tennessee, 37404, United States
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Nashville, Tennessee, 37205, United States
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Nashville, Tennessee, 37232, United States
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Austin, Texas, 78758, United States
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Dallas, Texas, 75216, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77054, United States
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Houston, Texas, 77099, United States
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Burlington, Vermont, 05401, United States
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Fairfax, Virginia, 22031, United States
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Norfolk, Virginia, 23507-1901, United States
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Salem, Virginia, 24153, United States
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Morgantown, West Virginia, 26506, United States
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Clayton, 3186, Australia
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Gosford, 2250, Australia
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Liverpool, 1871, Australia
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Parkville, 3050, Australia
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Perth, 6847, Australia
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Sydney, NSW 2148, Australia
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Woolloongabba, 4102, Australia
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Graz, 8036, Austria
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Aalst, 9300, Belgium
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Brussels, 1200, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Hasselt, 3500, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Liberec, 460 63, Czechia
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Ostrava, 708 52, Czechia
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Pilsen, 304 60, Czechia
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Aalborg, 9100, Denmark
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Odense, 5000, Denmark
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Roskilde, 4000, Denmark
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HUS, 00029, Finland
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Tampere, 33521, Finland
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Bayonne, 64115, France
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Bois-Guillaume, 76233, France
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Bordeaux, 33076, France
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Boulogne, 62321, France
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Cabestany, 66330, France
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Caen, 14033, France
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Chambéry, 73001, France
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Colmar, 68024, France
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Hyères, 83400, France
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La Tronche, 38700, France
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Limoges, 87042, France
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Lyon, 69437, France
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Montpellier, 34295, France
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Nantes, 44093, France
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Nîmes, 30029, France
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Paris, 75908, France
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Perpignan, 66046, France
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Poitiers, 86021, France
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Saint-Germain-en-Laye, 78100, France
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Saint-Ouen, 93400, France
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Salouël, 80480, France
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Tarbes, 65013, France
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Thionville, 57126, France
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Toulouse, 31059, France
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Tours, 37044, France
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Bad Hersfeld, 36251, Germany
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Berlin, 12045, Germany
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Dortmund, 44263, Germany
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Erlangen, 91054, Germany
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München, 80804, Germany
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Nuremberg, 90431, Germany
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Stuttgart, 70191, Germany
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Villingen-Schwenningen, 78054, Germany
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Wiesbaden, 65191, Germany
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Wiesloch, 69168, Germany
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Wuppertal, 42103, Germany
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Alexandroupoli, 68100, Greece
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Ioannina, 45500, Greece
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Larissa, 41110, Greece
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Piraeus, 18536, Greece
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Thessaloniki, 54629, Greece
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Budapest, 1076, Hungary
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Budapest, 1134, Hungary
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Debrecen, 4032, Hungary
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Miskolc, 3526, Hungary
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Pécs, 7624, Hungary
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Bergamo, 24128, Italy
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Cagliari, 91034, Italy
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Cremona, 26100, Italy
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Cuneo, 12100, Italy
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Genova, 16132, Italy
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Lecco, 23900, Italy
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Livorno, 57100, Italy
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Lodi, 26900, Italy
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Messina, 98158, Italy
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Mestre, 30174, Italy
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Modena, 41100, Italy
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Pavia, 27100, Italy
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Prato, 50047, Italy
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Reggio Calabria, 89100, Italy
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S Fermo Della Battaglia, 22020, Italy
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Venezia, 30122, Italy
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Cuernavaca, 62448, Mexico
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Mexico City, 14000, Mexico
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Heerlen, 6419 PC, Netherlands
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Trondheim, 7006, Norway
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Panama City, Panama
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Gdansk, 80-211, Poland
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Gdynia, 81-519, Poland
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Kielce, 25-736, Poland
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Krakow, 31-501, Poland
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Lodz, 90-153, Poland
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Poznan, 60-355, Poland
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Rzeszów, 35-055, Poland
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Szczecin, 70-111, Poland
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Warsaw, 02-006, Poland
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Wołomin, 05-200, Poland
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Wroclaw, 50-417, Poland
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Setúbal, 2910-446, Portugal
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Ponce, 00732, Puerto Rico
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Moscow, 123182, Russia
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Moscow, 125101, Russia
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Moscow, 129110, Russia
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Saint Petersburg, 195067, Russia
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Saint Petersburg, 197089, Russia
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Cape Town, 7925, South Africa
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Durban, South Africa
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Soweto, South Africa
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A Coruña, 15006, Spain
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Alcorcón, 28922, Spain
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Alicante, 03010, Spain
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Almería, 04009, Spain
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Badalona, 08915, Spain
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Barcelona, 08003, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Bilbao, 48013, Spain
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Córdoba, 14004, Spain
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L'Hospitalet de Llobregat, 08907, Spain
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Lleida, 25198, Spain
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Madrid, 28006, Spain
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Madrid, 28007, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Madrid, 28222, Spain
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Madrid, 28805, Spain
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Málaga, 29010, Spain
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Oviedo, 33006, Spain
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Palma de Mallorca, 07014, Spain
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Palma de Mallorca, 07198, Spain
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Salamanca, 37008, Spain
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Santander, 39008, Spain
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Santiago de Compostela, 15706, Spain
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Seville, 41013, Spain
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Huddinge, 14186, Sweden
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Karlstad, 65185, Sweden
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Stockholm, 18288, Sweden
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Umeå, 90185, Sweden
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Aarau, 5001, Switzerland
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Lausanne, 1003, Switzerland
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Lausanne, 1011, Switzerland
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Taichung, 407, Taiwan
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Taipei, 100, Taiwan
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Bangkok, Thailand
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Chiang Mai, 50200, Thailand
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Chon Buri, Thailand
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Phitsanulok, 65000, Thailand
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Belfast, BT9 7LJ, United Kingdom
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Cambridge, CB2 2QQ, United Kingdom
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Carshalton, SM5 1AA, United Kingdom
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Dundee, DD1 9SY, United Kingdom
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Exeter, EX2 5DW, United Kingdom
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Glasgow, G4 OSF, United Kingdom
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Leicester, LE5 4PW, United Kingdom
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London, E1 1BB, United Kingdom
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London, SE1 9RT, United Kingdom
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London, SE22 8PT, United Kingdom
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London, SW17 0RE, United Kingdom
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Salford, M6 8HD, United Kingdom
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Swansea, SA6 6NL, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2004
First Posted
September 6, 2004
Study Start
October 1, 2004
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
February 14, 2012
Results First Posted
January 5, 2012
Record last verified: 2012-02