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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02156310
Registration number
NCT02156310
Ethics application status
Date submitted
29/05/2014
Date registered
5/06/2014
Date last updated
5/06/2014
Titles & IDs
Public title
Mechanisms of Anti-VEGF Induced Hypertension
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Scientific title
Associations Between Antihypertensive Drugs and Patterns of Blood Pressure Changes: a Strategy to Reduce the Burden of Anti-VEGF Induced Hypertension
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Secondary ID [1]
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AAMFUSA001
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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:
Renal Cancer
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Condition category
Condition code
Cancer
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Kidney
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Cardiovascular
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0
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Hypertension
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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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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Changes in systolic blood pressure with different anti-hypertensive drug classes in anti-VEGF induced hypertension
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Assessment method [1]
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Timepoint [1]
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6 months
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Secondary outcome [1]
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Number of patients developing hypertension, i.e. >140/90 mmHg, with anti-VEGF drugs
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Assessment method [1]
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Timepoint [1]
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6 months
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Eligibility
Key inclusion criteria
- Renal Cancer
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Minimum age
No limit
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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
- Other terminal illness
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
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Actual
1/01/2009
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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
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Actual
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Sample size
Target
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Accrual to date
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Final
2000
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Department of Clinical Pharmacology - Adelaide
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Recruitment postcode(s) [1]
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5042 - Adelaide
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Funding & Sponsors
Primary sponsor type
Other
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Name
Arduino Mangoni
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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
Background: High blood pressure is a common complication observed in cancer patients
prescribed anti-VEGF drugs. Increased blood pressure increases the risk of heart attacks and
strokes, thus adversely affecting survival and quality of life in this patient group.
However, little is known about the mechanisms leading to high blood pressure with anti-VEGF
drugs. As a result, the management of anti-VEGF drug-induced hypertension is largely
empirical. A better knowledge of effects of specific blood pressure lowering drugs, i.e.
antihypertensives, on anti-VEGF drug-induced hypertension would optimize therapeutic
management and reduce the risk associated with hypertension and proteinuria in patients with
cancer.
Methods: Datasets of two completed GSK clinical trials using the anti-VEGF drug pazopanib,
i.e. VEG108844 and VEG105192, will be accessed to 1) determine the way blood pressure changes
over time after commencing anti-VEGF treatment; 2) identify whether there are any
relationships between pre-study and baseline blood pressure values, treatment with specific
antihypertensive drugs, and changes in blood pressure after commencing anti-VEGF treatment;
and 3) identify whether specific antihypertensive drugs and drug combinations, prescribed
either before or after commencing anti-VEGF treatment, lead to a better blood pressure
control and prevent proteinuria during anti-VEGF treatment. Specific statistical analyses
will be conducted to assess and identify associations and will account for other patient's
characteristics and repeated observations over time. The investigators plan to conduct this
study over 6 months.
Studies VEG108844 and VEG105192 have been selected as they investigate the same anti-VEGF
drug, pazopanib, in a homogeneous group, i.e. patients with renal cancer. At the same time,
inclusion of a placebo arm as well as a treatment arm with a different anti-VEGF drug,
sunitimib, will allow initial comparisons across different groups.
The results deriving from this study will provide important knowledge on 1) patterns of blood
pressure changes with anti-VEGF drugs and 2) whether specific antihypertensive drugs or drug
classes might be better than others in preventing and managing anti-VEGF induced hypertension
and proteinuria.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02156310
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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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Arduino A Mangoni, MD, PhD
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Address
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Flinders University
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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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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02156310
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