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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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]

AAMFUSA001

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Renal Cancer

Condition category

Condition code

Cancer

Kidney

Cardiovascular

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]

Changes in systolic blood pressure with different anti-hypertensive drug classes in anti-VEGF induced hypertension

Timepoint [1]

6 months

Secondary outcome [1]

Number of patients developing hypertension, i.e. >140/90 mmHg, with anti-VEGF drugs

Timepoint [1]

6 months

Eligibility

Key inclusion criteria

* Renal Cancer

Minimum age

No limit

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

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

1/01/2009

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

2000

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Department of Clinical Pharmacology - Adelaide

Recruitment postcode(s) [1]

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/study/NCT02156310

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Arduino A Mangoni, MD, PhD

Address

Flinders University

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

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/NCT02156310

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02156310