Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Study to Evaluate Pazopanib as an Adjuvant Treatment for Localized Renal Cell Carcinoma (RCC) (PROTECT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01235962
First received: October 14, 2010
Last updated: August 8, 2016
Last verified: August 2016
  Purpose
This randomized Phase III study is to evaluate whether pazopanib compared with placebo can prevent or delay recurrence of kidney cancer in patients with moderately high or high risk of developing recurrence after undergoing kidney cancer surgery

Condition Intervention Phase
Cancer
Drug: pazopanib
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Pazopanib as Adjuvant Therapy for Subjects With Localized or Locally Advanced RCC Following Nephrectomy

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: approximately 9 years ] [ Designated as safety issue: No ]
  • Disease-free survival rates at yearly time points (e.g. 1 year, 2 years, etc.). [ Time Frame: yearly for 4 or 5 years ] [ Designated as safety issue: No ]
  • Safety (frequency and severity of adverse events and laboratory abnormalities) [ Time Frame: approximately 12 months ] [ Designated as safety issue: Yes ]
  • Health Outcome (change from baseline in patients' self-reports on health outcome and quality of life as measured by two instruments: Cancer Therapy-Kidney Symptom Index-19 and EuroQOL-5D [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]

Enrollment: 1540
Study Start Date: November 2010
Estimated Study Completion Date: April 2019
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pazopanib
Pazopanib oral agent, administered at 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months. Dose can be reduced, interrupted or discontinued due to adverse events or intolerance.
Drug: pazopanib
Pazopanib 600 mg daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.
Other Name: Votrient
Placebo Comparator: placebo
placebo matching pazopanib 200 mg tablets, administered at 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months. Dose can be reduced, interrupted or discontinued due to adverse events or intolerance.
Drug: placebo
placebo matching pazopanib daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent
  • Diagnosis of RCC with clear-cell or predominant clear-cell histology
  • Subjects with non-metastatic disease (M0) fulfilling any of the following combinations of pathologic staging based on American Joint Committee on Cancer (AJCC) TNM staging version 2010 and Fuhrman nuclear grading.

    • pT2, G3 or G4, N0; or,
    • pT3, G any, N0; or,
    • pT4, G any, N0; or,
    • pT any, G any, N1
  • Fulfill all of the following criteria of disease-free status at baseline:

    • Had complete gross surgical resection of all RCC via radical or partial nephrectomy using either open or laparoscopic technique.
    • Baseline imaging of chest, abdomen and pelvis shows no metastasis or residual tumor lesions as confirmed centrally by an independent radiologist.
  • Received no prior adjuvant or neo-adjuvant treatment for RCC
  • Recovered from nephrectomy: any surgery related toxicities should be reduced to ≤ grade 1 per NCI Common Terminology Criteria for Adverse Events (CTCAE) (Version 4)
  • Karnofsky performance scale (KPS) of ≥ 80
  • Adequate organ system function

Exclusion Criteria:

  • History of another malignancy. Exception: Subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible
  • Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:

    • Active peptic ulcer disease
    • Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation
    • History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment
  • Active diarrhea of any grade
  • Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:

    • Malabsorption syndrome
    • Major resection of the stomach or small bowel
  • History of human immunodeficiency virus (HIV) infection
  • History of active hepatitis
  • Presence of uncontrolled infection.
  • History of any one or more of the following cardiovascular conditions within the past 6 months:

    • Cardiac angioplasty or stenting
    • Myocardial infarction
    • Unstable angina
    • Coronary artery bypass graft surgery
    • Symptomatic peripheral vascular disease
  • History of Class III or IV congestive heart failure, as defined by the New York Heart Association Classification of Congestive Heart Failure
  • History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
  • Corrected QT interval (QTc) > 480 milliseconds (msec)
  • Poorly controlled hypertension, defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg.

Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study (see Section 7.6.2 for instruction on blood pressure measurement and obtaining mean blood pressure values).

  • Evidence of active bleeding or bleeding diathesis
  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
  • Unable or unwilling to discontinue use of prohibited medications for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study treatment and for the duration of the study.
  • Concurrent therapy given to treat cancer including treatment with an investigational agent or concurrent participation in another clinical trial involving anti-cancer investigational drug.
  • Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment.
  • Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or excipients that in the opinion of the investigator contraindicates their participation.
  • Prior or current use of systemic anti-VEGF inhibitors, cytokines (e.g. interferon, interleukin 2).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235962

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Locations
United States, Arkansas
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Jonesboro, Arkansas, United States, 72401
United States, California
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Antioch, California, United States, 94531
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Beverly Hills, California, United States, 90211
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Fresno, California, United States, 93720
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La Jolla, California, United States, 92093
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Los Angeles, California, United States, 90033
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Los Angeles, California, United States, 90048-0750
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Los Angeles, California, United States, 90095
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Oakland, California, United States, 94611
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Roseville, California, United States, 95661
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Sacramento, California, United States, 95825
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San Francisco, California, United States, 94115
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San Jose, California, United States, 95119-1110
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Santa Clara, California, United States, 95051
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South San Francisco, California, United States, 94080
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Stanford, California, United States, 94305
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Vallejo, California, United States, 94589
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Walnut Creek, California, United States, 94596
United States, Colorado
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Ft. Collins, Colorado, United States, 80528
United States, District of Columbia
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Washington, District of Columbia, United States, 20007
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Fort Myers, Florida, United States, 33916
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Tampa, Florida, United States, 33612
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Athens, Georgia, United States, 30607
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Macon, Georgia, United States, 31201
United States, Illinois
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Chicago, Illinois, United States, 60637
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Indianapolis, Indiana, United States, 46202
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Iowa City, Iowa, United States, 52242
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Baltimore, Maryland, United States, 21287
United States, Massachusetts
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Boston, Massachusetts, United States, 02114
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Boston, Massachusetts, United States, 02115
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Boston, Massachusetts, United States, 02215
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Burlington, Massachusetts, United States, 01805
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Detroit, Michigan, United States, 48201
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Rochester, Minnesota, United States, 55905
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St. Louis Park, Minnesota, United States, 55426
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St. Louis, Missouri, United States, 63110
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Lincoln, Nebraska, United States, 68510
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Omaha, Nebraska, United States, 68114
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Omaha, Nebraska, United States, 68118
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Las Vegas, Nevada, United States, 89169
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Hackensack, New Jersey, United States, 07601
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Albany, New York, United States, 12206
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Buffalo, New York, United States, 14263
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Durham, North Carolina, United States, 27710
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Providence, Rhode Island, United States, 02903
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Charleston, South Carolina, United States, 29425
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Nashville, Tennessee, United States, 37232-5536
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Bedford, Texas, United States, 76022
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Virginia Beach, Virginia, United States, 23462
United States, Washington
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Seattle, Washington, United States, 98109
Argentina
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Berazategui, Buenos Aires, Argentina, B1880BBF
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Capital Federal, Buenos Aires, Argentina, C1426ANZ
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1050AAK
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1280AEB
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1405BCH
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Quilmes, Buenos Aires, Argentina, 1878
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Cipolletti, RÃ-o Negro, Argentina, R8324EMB
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Cardova, Argentina, X5006HBF
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San Miguel de Tucumán, Argentina, T4000IAK
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Santa Fe, Argentina, 3000
Austria
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Graz, Austria, 8036
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Innsbruck, Austria, 6020
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Salzburg, Austria, 5020
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Salzburg, Austria, A-5020
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Vienna, Austria, 1130
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Vienna, Austria, A-1090
Belgium
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Hasselt, Belgium, 3500
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Jette, Belgium, 1090
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Liage, Belgium, 4000
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Namur, Belgium, 5000
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Roeselare, Belgium, 8800
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Wilrijk, Belgium, 2610
Brazil
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Belo Horizonte, Minas Gerais, Brazil, 30130-100
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Curitiba, Paranai, Brazil, 81520-060
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Ijui, Rio Grande Do Sul, Brazil, 98700-000
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Porto Alegre, Rio Grande Do Sul, Brazil, 90610000
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Campinas, Sao Paulo, Brazil, 13083-970
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Barretos, São Paulo, Brazil, 14784-400
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Rio de Janeiro, Brazil, 20 551-030
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Rio de Janeiro, Brazil, 20231-050
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Sao Paulo, Brazil, 01246-000
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Canada, Alberta
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Vancouver, British Columbia, Canada, V5Z 1M9
Canada, New Brunswick
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Moncton, New Brunswick, Canada, E1C 6Z8
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Halifax, Nova Scotia, Canada, B3H 1V7
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Hamilton, Ontario, Canada, L8V 5C2
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Ottawa, Ontario, Canada, K1H 8L6
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Toronto, Ontario, Canada, M4N 3M5
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Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
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Montreal, Quebec, Canada, H2L 4M1
Canada
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Quebec, Canada, G1R 2J6
Chile
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Santiago, Región Metro De Santiago, Chile, 7500921
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Via del Mar, ValparaÃ-so, Chile, 254-0364
China, Hubei
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Wuhan, Hubei, China, 430030
China, Zhejiang
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Hangzhou, Zhejiang, China, 310003
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Hangzhou, Zhejiang, China, 310009
China
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Beijing, China, 100021
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Beijing, China, 100034
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Beijing, China, 100191
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Beijing, China, 100853
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Shanghai, China, 200025
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Shanghai, China, 200032
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Shanghai, China, 200040
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Shanghai, China, 200127
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Tianjin, China, 300060
Czech Republic
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Brno, Czech Republic, 656 53
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Brno, Czech Republic, 656 91
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Hradec Kralove, Czech Republic, 500 05
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Novy Jicin, Czech Republic, 741 01
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Olomouc, Czech Republic, 775 20
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Ostrava - Poruba, Czech Republic, 708 52
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Plzen, Czech Republic, 304 60
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Praha 2, Czech Republic, 12808
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Praha 8, Czech Republic, 180 00
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Usti nad Labem, Czech Republic, 40113
Denmark
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Aarhus, Denmark, 8000 Aarhus C
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DK-2730 Herlev, Denmark, 2730
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Odense C, Denmark, 5000
France
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Angers cedex 9, France, 49933
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Besançon cedex, France, 25030
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Bordeaux, France, 33075
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Caen Cedex 05, France, 14076
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Hyeres, France, 83400
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Le Mans, France, 72000
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Marseille cedex 5, France, 13385
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Montpellier Cedex 5, France, 34295
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Paris Cedex 15, France, 75908
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Paris, France, 75014
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Poitiers Cedex, France, 86021
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Reims, France, 51100
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Rennes, France, 35042
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Saint Herblain, France, 44805
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Strasbourg cedex, France, 67085
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Strasbourg Cedex, France, 67091
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Toulouse, France, 31076
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Tours Cedex 9, France, 37044
Germany
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Kirchheim, Baden-Wuerttemberg, Germany, 73230
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Ravensburg, Baden-Wuerttemberg, Germany, 88212
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Sigmaringen, Baden-Wuerttemberg, Germany, 72488
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Stuttgart, Baden-Wuerttemberg, Germany, 70174
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Tuebingen, Baden-Wuerttemberg, Germany, 72076
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Ulm, Baden-Wuerttemberg, Germany, 89075
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Erlangen, Bayern, Germany, 91054
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Fuerth, Bayern, Germany, 90766
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Muenchen, Bayern, Germany, 81675
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Regensburg, Bayern, Germany, 93053
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Weiden, Bayern, Germany, 92637
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Frankfurt, Hessen, Germany, 60590
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Marburg, Hessen, Germany, 35043
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Offenbach, Hessen, Germany, 63069
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Braunschweig, Niedersachsen, Germany, 38126
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Goslar, Niedersachsen, Germany, 38642
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Hannover, Niedersachsen, Germany, 30625
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Aachen, Nordrhein-Westfalen, Germany, 52074
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Bergisch Gladbach, Nordrhein-Westfalen, Germany, 51465
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Bonn, Nordrhein-Westfalen, Germany, 53127
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Duisburg, Nordrhein-Westfalen, Germany, 47179
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Essen, Nordrhein-Westfalen, Germany, 45122
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Moenchengladbach, Nordrhein-Westfalen, Germany, 41063
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Muenster, Nordrhein-Westfalen, Germany, 48149
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Neuss, Nordrhein-Westfalen, Germany, 41464
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Velbert, Nordrhein-Westfalen, Germany, 42551
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Mainz, Rheinland-Pfalz, Germany, 55131
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Homburg, Saarland, Germany, 66421
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Dessau, Sachsen-Anhalt, Germany, 06846
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Eisleben, Sachsen-Anhalt, Germany, 06295
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Halle, Sachsen-Anhalt, Germany, 06120
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Chemnitz, Sachsen, Germany, 09130
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Leipzig, Sachsen, Germany, 04277
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Plauen, Sachsen, Germany, 08523
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Luebeck, Schleswig-Holstein, Germany, 23566
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Jena, Thueringen, Germany, 07768
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Berlin, Germany, 10719
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Berlin, Germany, 10967
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Berlin, Germany, 12200
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Bremen, Germany, 28177
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Hamburg, Germany, 20246
Greece
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Athens, Greece, 115 22
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Heraklion, Crete, Greece, 71100
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Patra, Greece, 26504
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Thessaloniki, Greece
Hungary
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Budapest, Hungary, 1082
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Budapest, Hungary, 1097
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Budapest, Hungary, 1122
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Miskolc, Hungary, 3526
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NyÃ-regyháza, Hungary, 4400
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Szombathely, Hungary, 9700
Ireland
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Co.Cork, Ireland
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Dublin, Ireland, 7
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Dublin, Ireland, 9
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Galway, Ireland
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Tallaght, Dublin, Ireland, 24
Israel
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Haifa, Israel, 31096
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Jerusalem, Israel, 91120
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Petach-Tikva, Israel, 49100
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Rehovot, Israel, 76100
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Tel Aviv, Israel, 64239
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Zrifin, Israel, 70300
Italy
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Napoli, Campania, Italy, 80131
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Bologna, Emilia-Romagna, Italy, 40138
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Meldola (FC), Emilia-Romagna, Italy, 47014
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Modena, Emilia-Romagna, Italy, 41100
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Roma, Lazio, Italy, 00144
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Roma, Lazio, Italy, 00152
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Milano, Lombardia, Italy, 20133
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Pavia, Lombardia, Italy, 27100
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Candiolo (TO), Piemonte, Italy, 10060
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Perugia, Umbria, Italy, 06122
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Terni, Umbria, Italy, 05100
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Negrar, Veneto, Italy, 37024
Japan
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Fukuoka, Japan, 812-8582
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Hokkaido, Japan, 060-8543
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Hokkaido, Japan, 060-8648
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Kanagawa, Japan, 236-0004
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Okayama, Japan, 700-8558
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Osaka, Japan, 589-8511
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Shizuoka, Japan, 431-3192
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Tokyo, Japan, 113-8603
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Tokyo, Japan, 160-8582
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Tokyo, Japan, 162-8666
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Yamagata, Japan, 990-9585
Korea, Republic of
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Daejeon, Korea, Republic of, 301-721
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Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
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Jeonju, Korea, Republic of, 561-712
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Seongnam-si Gyeonggi-do, Korea, Republic of, 463-707
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Seoul, Korea, Republic of, 110-744
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Seoul, Korea, Republic of, 120-752
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Seoul, Korea, Republic of, 135-710
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Seoul, Korea, Republic of, 136-705
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songpa-gu, Seoul, Korea, Republic of, 138-736
Luxembourg
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Luxembourg, Luxembourg, 1210
Poland
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Gdansk, Poland, 80-219
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Konin, Poland, 62-500
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Krakow, Poland, 31-108
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Krakow, Poland, 31-115
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Lublin, Poland, 20-090
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Warszawa, Poland, 02-776
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Warszawa, Poland, 02-781
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Warszawa, Poland, 04-125
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Wroclaw, Poland, 50-556
Russian Federation
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Arkhangelsk, Russian Federation, 163045
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Barnaul, Russian Federation, 656049
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Chelyabinsk, Russian Federation, 454087
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Ekaterinburg, Russian Federation, 620102
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Kazan, Russian Federation, 420029
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Moscow, Russian Federation, 115478
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Moscow, Russian Federation, 117997
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Obninsk, Russian Federation, 249036
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Omsk, Russian Federation, 644013
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Rostov-na-Donu, Russian Federation
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Ryazan, Russian Federation, 390011
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Saint Petersburg, Russian Federation
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St. Petersburg, Russian Federation, 197758
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Stavropol, Russian Federation, 355047
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Ufa,, Russian Federation, 450054
Slovakia
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Banska Bystrica, Slovakia, 975 17
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Bratislava, Slovakia, 833 05
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Kosice, Slovakia, 041 66
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Martin, Slovakia, 036 59
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Zilina, Slovakia, 012 07
Spain
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Badalona, Spain, 08916
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Barcelona, Spain, 08035
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Carrdoba, Spain, 14004
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Dos Hermanas (Sevilla), Spain, 41700
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Madrid, Spain, 28007
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Madrid, Spain, 28033
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Madrid, Spain, 28041
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Madrid, Spain, 28050
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Malaga, Spain, 29010
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Oviedo, Spain, 33006
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Sevilla, Spain, 41013
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Valencia, Spain, 46009
Turkey
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Ankara, Turkey, 06100
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Ankara, Turkey, 06590
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Istanbul, Turkey, 34390
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Izmir, Turkey, 35100
United Kingdom
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Brighton, United Kingdom, BN2 5BE
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Cornwall, United Kingdom, TR1 3LJ
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Guildford, United Kingdom, GU2 7XX
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London, United Kingdom, NW3 2QG
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London, United Kingdom, SE1 9RT
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Manchester, United Kingdom, M20 4BX
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Preston, United Kingdom, PR2 9HT
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Swansea, United Kingdom, SA2 8QA
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Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01235962     History of Changes
Other Study ID Numbers: 113387 
Study First Received: October 14, 2010
Last Updated: August 8, 2016
Health Authority: Canada: Health Products and Foods Branch, Health Canada
Spain: Agencia Espanola de Medicamentos y Productos Sanitarios
Slovakia: State Institute for Drug Control
Argentina: Ministry of Health - A.N.M.A.T
Belgium: Agence Fédérale des Médicaments et des Produits de la Santé
Brazil: National Health Surveillance Agency
Italy: Agenzia Italiana del Farmaco
Chile:Ministerio de Salud de Chile
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Ireland: Irish Medicines Board
United States: Food and Drug Administration
Austria: Austrian Medicines and Medical Devices Agency (AGES PharmMed)
South Korea: Korea Food and Drug Administration (KFDA)
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
Denmark: Danish Medicines Agency
France: Agence Française de Sécurité Sanitaire des Produits de Santé
Russia: Ministry of Health of the Russian Federation
Japan: Pharmaceuticals and Medical Devices Agency
Israel: Ministry of Health
China: Food and Drug Administration
Europe: European Medicines Agency
Turkey: Ministry of Health
Czech Republic: State Institute for Drug Control

Keywords provided by Novartis:
anti-angiogenic agent
renal cell carcinoma
pazopanib
adjuvant therapy
VEGFR inhibitor

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 23, 2016