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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01964235
Registration number
NCT01964235
Ethics application status
Date submitted
14/10/2013
Date registered
17/10/2013
Date last updated
1/09/2016
Titles & IDs
Public title
Study of Efficacy and Safety INC280 in Patients With Advanced Hepatocellular Carcinoma
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Scientific title
A Randomized Phase II, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of INC280 in Adult Patients With Advanced Hepatocellular Carcinoma After Progression or Intolerance to Sorafenib Treatment
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Secondary ID [1]
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CINC280X2203
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Hepatocellular Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Liver
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - INC280
Treatment: Drugs - Placebo
Experimental: INC280 plus best supportive care - Approximately 46 patients will be treated with INC280 600 mg twice a day plus best supportive care.
Placebo comparator: Placebo plus best supportive care - Approximately 23 patients will be treated with matching placebo twice a day plus best supportive care.
Treatment: Drugs: INC280
INC280 will be administered orally and continuously on a twice a day dosing schedule.
Treatment: Drugs: Placebo
Placebo will be administered orally and continuously on a twice a day dosing schedule.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to progression using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
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Assessment method [1]
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Time to progression is the time from the date of baseline evaluation to the date of the first documented radiological confirmation of disease progression.
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Timepoint [1]
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baseline, 6 weeks up to 6 months
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Secondary outcome [1]
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Best Overall Response
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Assessment method [1]
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Best overall response is defined as the best response recorded from the date of randomization until the date of last tumor assessment per RECIST version 1.1.
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Timepoint [1]
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date of treatment, every 6 weeks up to 6 months
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Secondary outcome [2]
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Overall Response Rate
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Assessment method [2]
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Overall Response Rate is defined as the proportion of patients with a best overall response of complete response or partial response at any time on study per RECIST version 1.1.
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Timepoint [2]
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baseline, every 6 weeks up to 6 months
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Secondary outcome [3]
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Disease Control Rate
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Assessment method [3]
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Disease control rate is defined as the proportion of patients with a best overall response of complete response, partial response or stable disease at any time on study per RECIST version 1.1.
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Timepoint [3]
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baseline, every 6 weeks up to 6 months
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Secondary outcome [4]
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Progression Free Survival
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Assessment method [4]
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Progression free survival is defined as the time from date of randomization to the date of the first radiologically documented progression or death due to any cause. If a patient has not experienced radiologically documented progression or death, progression free survival is censored at the date of last adequate tumor assessment.
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Timepoint [4]
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randomization, every 6 weeks up to 6 months
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Secondary outcome [5]
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Overall Survival
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Assessment method [5]
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Overall survival is defined as the time from date of randomization to the date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last contact.
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Timepoint [5]
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randomization until death, average 10 months
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Secondary outcome [6]
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Safety: adverse events, serious adverse events
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Assessment method [6]
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Frequency, duration and severity of adverse events.
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Timepoint [6]
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From baseline until 30 days post study treatment
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Secondary outcome [7]
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Safety: hematology and chemistry values, vital signs, electrocardiograms
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Assessment method [7]
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Change from baseline values.
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Timepoint [7]
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From baseline until end of treatment, average 6 months from baseline
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Secondary outcome [8]
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Tolerability of study drug
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Assessment method [8]
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Tolerability will be assessed by summarizing the number of dose interruptions, dose reductions and dose intensity.
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Timepoint [8]
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From date of randomization until end of treatment, average 6 months from baseline
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Eligibility
Key inclusion criteria
* Confirmed c-MET pathway dysregulation.- Hepatocellular carcinoma stage B or C according to the Barcelona Clinic Liver cancer staging classification. - Current cirrhotic status of Child-Pugh class A with no encephalopathy. - Documented disease progression during or after discontinuation of sorafenib treatment or intolerance to sorafenib treatment. - Measurable disease as determined by RECIST v1.1. - ECOG performance status = 1
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Previous local antineoplastic therapy or investigational drug completed less than 5 half-lives of the agent prior to randomization and have not recovered from clinically significant toxicity from such treatment to grade =1 by the NCI-CTCAE. - Received any targeted therapy other than sorafenib.
* Active bleeding within 28 days prior to screening visit including variceal bleeding (esophageal varices should be treated according to standard practice and procedure completed 28 days prior to screening visit). - Clinically significant venous or arterial thrombotic disease within past 6 months.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Withdrawn
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/12/2016
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2019
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Kogarah
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Recruitment hospital [2]
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Novartis Investigative Site - Heidelberg
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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3084 - Heidelberg
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Massachusetts
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Country [2]
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United States of America
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State/province [2]
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Missouri
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Country [3]
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France
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State/province [3]
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Clichy
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Country [4]
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France
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State/province [4]
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LILLE Cedex
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Country [5]
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France
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State/province [5]
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Montpellier Cedex 5
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Country [6]
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France
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State/province [6]
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Nice Cedex 3
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Country [7]
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Germany
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State/province [7]
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Essen
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Country [8]
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Germany
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State/province [8]
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Würzburg
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Country [9]
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Hong Kong
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State/province [9]
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Hong Kong SAR
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Country [10]
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Hong Kong
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State/province [10]
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Hong Kong
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Country [11]
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Spain
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State/province [11]
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Andalucia
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Country [12]
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Switzerland
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State/province [12]
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Bern
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Country [13]
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Switzerland
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State/province [13]
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Genève
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is establish whether INC280 is safe and has beneficial effects in patients with advanced hepatocellular carcinoma known to have dysregulation of c-MET pathway and whose disease progressed while on, or after, treatment with sorafenib or who are intolerant to sorafenib. Patients will be randomized in a 2:1 ratio to receive INC280 at 600mg BID plus best supportive care (BSC) or placebo plus BSC, until disease progression or intolerable to study treatment. Patients treated with placebo plus BSC will have the opportunity to receive INC280 treatment upon documented further disease progression (RECIST 1.1) per investigator's discretion after unblinding. Patient will be stratified to geographical region (Asia vs Rest of World ) and tumor burden (present macroscopic vascular invasion and/or extra-hepatic spread vs not present).
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Trial website
https://clinicaltrials.gov/study/NCT01964235
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01964235
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