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Bevacizumab and Endothelium Dependent Vasodilation


N/A
18 Years
50 Years
Not Enrolling
Male
Hypertension, Cancer, Endothelial Dysfunction

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Trial Information

Bevacizumab and Endothelium Dependent Vasodilation


Inclusion Criteria:



1. Age 18-50 years old

2. Male

3. Results of serum glucose, lipids and creatinine should be within the laboratory's
reference ranges.

4. Subject is able and willing to sign the Informed Consent Form prior to screening
evaluations.

Exclusion Criteria:

1. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.

2. History of or current abuse of drugs, alcohol or solvents.

3. History of malignant disease.

4. First degree relatives with a history of cancer before the age of 50

5. First degree relatives with a history of premature cardiovascular disease before the
age of 50

6. Current use of medication.

7. Clinical evidence of cardiac or pulmonary disease

8. Hypertension ( systole >140mmHG, diastole >90mmHg)

9. Diabetes mellitus

10. Smoking

11. Any clinically relevant abnormality on ECG.

12. A history of thrombosis or first degree family members with a history of recurrent
thrombosis

13. Inability to understand the nature and extent of the trial and the procedures
required.

14. Previous participation in a study with bevacizumab

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Vasomotor response assessed by venous occlusion strain gauge plethysmography

Outcome Description:

Response to infusion of bevacizumab and/or acetylcholin or nitroprusside

Outcome Time Frame:

15 minutes

Safety Issue:

No

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

BVZAch

NCT ID:

NCT01125943

Start Date:

June 2010

Completion Date:

November 2011

Related Keywords:

  • Hypertension
  • Cancer
  • Endothelial Dysfunction
  • Hypertension

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