Bevacizumab and Vasoconstriction

NCT ID: NCT00929058

Last Updated: 2010-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Rationale: The introduction of angiogenesis inhibitors has remarkably improved treatment of patients with several types of cancer. One of the most common side effects of angiogenesis inhibitors is hypertension. In patients treated with bevacizumab hypertension had an overall incidence up to 32%. The etiology of hypertension caused by treatment with angiogenesis inhibitors is unclear.

Objective: To study if arterial bevacizumab infusion causes acute vasoconstriction using plethysmography in healthy volunteers.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bevacizumab

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

Intra-arterial infusion during 6 minutes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bevacizumab

Intra-arterial infusion during 6 minutes

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male 18-50 years old
* normal results of glucose, lipids and creatinine
* informed consent

Exclusion Criteria

* History of abuse of drugs or alcohol
* History of malignant disease
* First degree relatives with a history of cancer before the age of 50
* First degree relatives with a history of premature cardiovascular disease
* Current use of medication
* Clinical evidence of cardiac of pulmonary disease
* Hypertension ( systolic\>140mmHg, diastolic \>90mmHg)
* Diabetes mellitus
* smoking
* a history of thombosis or a family history of recurrent thrombosis
* abnormality on ECG
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

UMCN

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gerard Rongen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UMCN

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BVZ1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effects of Tetrahydrobiopterin on Blood Pressure
NCT00208780 COMPLETED EARLY_PHASE1
Angiotensin-(1-7) Cardiovascular Effects in Aging
NCT05301192 RECRUITING EARLY_PHASE1