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Angiogenesis Inhibitors and Hypertension: Clinical Aspects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00511511
First Posted: August 6, 2007
Last Update Posted: January 5, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Erasmus Medical Center
  Purpose
The aim of the study is to find simple clinical and laboratory parameters to predict the development of hypertension and to elucidate the mechanism of hypertension during treatment with the tyrosine kinase inhibitor Sunitinib.

Condition
Hypertension

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Angiogenesis Inhibitors and Hypertension: Clinical Aspects

Further study details as provided by Erasmus Medical Center:

Biospecimen Retention:   Samples Without DNA
Blood and urine samples

Estimated Enrollment: 80
Study Start Date: August 2007
Study Completion Date: December 2009
Detailed Description:
Inhibition of angiogenesis with antibodies against vascular endothelial growth factor (VEGF) and VEGF receptor antagonists has become an established treatment for cancer. An unanticipated side effect of angiogenesis inhibitors is the development of hypertension. The pathogenesis of this hypertension is unknown. Not all patients will develop hypertension. However, it is not known which patient will and which patient will not develop hypertension.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Men and women, with either renal cell carcinoma or gastro intestinal stromal tumors (GIST) intended to be treated solely with Sunitinib (single-agent treatment) and who are considered fit enough by their treating physician to receive Sunitinib
Criteria

Inclusion Criteria:

  • Men and women, with either renal cell carcinoma or gastro intestinal stromal tumors (GIST) intended to be treated solely with Sunitinib (single-agent treatment) and who are considered fit enough by their treating physician to receive Sunitinib.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00511511


Locations
Netherlands
Erasmus MC
Rotterdam, Netherlands, 3015 CE
Sponsors and Collaborators
Erasmus Medical Center
Investigators
Principal Investigator: A. H. van den Meiracker, MD, PhD Erasmus Medical Center
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00511511     History of Changes
Other Study ID Numbers: MEC-2007-155
EudraCT-number: 2007-002038-13
First Submitted: August 3, 2007
First Posted: August 6, 2007
Last Update Posted: January 5, 2010
Last Verified: July 2009

Keywords provided by Erasmus Medical Center:
hypertension
angiogenesis inhibitors
tyrosine kinase inhibitor
Sunitinib

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents