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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
Associations Between Antihypertensive Drugs and Patterns of Blood Pressure Changes: a Strategy to Reduce the Burden of Anti-VEGF Induced Hypertension
Secondary ID [1] 0 0
AAMFUSA001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in systolic blood pressure with different anti-hypertensive drug classes in anti-VEGF induced hypertension
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Number of patients developing hypertension, i.e. >140/90 mmHg, with anti-VEGF drugs
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
- Renal Cancer
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Other terminal illness

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Department of Clinical Pharmacology - Adelaide
Recruitment postcode(s) [1] 0 0
5042 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
Arduino Mangoni
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02156310
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Arduino A Mangoni, MD, PhD
Address 0 0
Flinders University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications