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Mechanisms of Anti-VEGF Induced Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arduino Mangoni, Flinders University
ClinicalTrials.gov Identifier:
NCT02156310
First received: May 29, 2014
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition
Renal Cancer

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Associations Between Antihypertensive Drugs and Patterns of Blood Pressure Changes: a Strategy to Reduce the Burden of Anti-VEGF Induced Hypertension

Resource links provided by NLM:


Further study details as provided by Flinders University:

Primary Outcome Measures:
  • Changes in systolic blood pressure with different anti-hypertensive drug classes in anti-VEGF induced hypertension [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients developing hypertension, i.e. >140/90 mmHg, with anti-VEGF drugs [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Number of patients developing proteinuria with anti-VEGF drugs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Survival of renal cancer patients on anti-VEGF drugs [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 2000
Study Start Date: January 2009
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with renal cancer randomised to active treatment, active comparator or placebo in two finished randomised controlled trials

Criteria

Inclusion Criteria:

  • Renal Cancer

Exclusion Criteria:

  • Other terminal illness
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02156310

Locations
Australia, South Australia
Department of Clinical Pharmacology
Adelaide, South Australia, Australia, 5042
Sponsors and Collaborators
Arduino Mangoni
Investigators
Principal Investigator: Arduino A Mangoni, MD, PhD Flinders University
  More Information

No publications provided

Responsible Party: Arduino Mangoni, Professor of Clinical Pharmacology, Flinders University
ClinicalTrials.gov Identifier: NCT02156310     History of Changes
Other Study ID Numbers: AAMFUSA001
Study First Received: May 29, 2014
Last Updated: June 3, 2014
Health Authority: Australia: National Health and Medical Research Council

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

ClinicalTrials.gov processed this record on November 24, 2014