HypertensionBVZ1NCT00929058
Bevacizumab and Vasoconstriction
A study testing Bevacizumab in people with Hypertension and Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
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%. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Cancer
- What is being tested?
- Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2009to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male 18-50 years old
- normal results of glucose, lipids and creatinine
- informed consent
Who cannot join
- 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
Show all 11Show fewer
- Hypertension ( systolic>140mmHg, diastolic >90mmHg)
- Diabetes mellitus
- smoking
- a history of thombosis or a family history of recurrent thrombosis
- abnormality on ECG
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6500
About this study
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.
- Conditions
- Hypertension, Cancer
- Being tested
- Bevacizumab
- Medical subject headings
- Hypertension, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Intra-arterial infusion during 6 minutes
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab | Experimental | Not described Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fore-arm vasomotor response to administered bevacizumab, expressed as percentage change in forearm blood flow ratio
Measured: Infusion of bevacizumab during 6 minutes
Secondary outcomes (1)
Correlation between VEGF concentrations in plasma and the vasoconstrictive response to bevacizumab
Measured: Infusion of bevacizumab during 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Gerard Rongen, MD PhD, Principal investigator, UMCN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929058
- Sponsor's protocol ID
- BVZ1
- Acronym
- BVZ1
- Status last verified
- Jun 2009
- First submitted
- 25 Jun 2009
- Last updated
- 18 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bevacizumab and Vasoconstriction
- ClinicalTrials.gov ID
- NCT00929058
- Acronym / sponsor ID
- BVZ1 / BVZ1
- Conditions
- Hypertension, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 26 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | Experimental | Drug: Bevacizumab |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male 18-50 years old
- normal results of glucose, lipids and creatinine
- informed consent
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabIntra-arterial infusion during 6 minutes | Drug | Bevacizumab |
Primary outcome
Fore-arm vasomotor response to administered bevacizumab, expressed as percentage change in forearm blood flow ratio
Time frame: Infusion of bevacizumab during 6 minutes
1 secondary outcome
Correlation between VEGF concentrations in plasma and the vasoconstrictive response to bevacizumab
Time frame: Infusion of bevacizumab during 6 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerard Rongen, MD PhD principal investigator
UMCN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bevacizumab in people with Hypertension and Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fore-arm vasomotor response to administered bevacizumab, expressed as percentage change in forearm blood flow ratio (time frame: Infusion of bevacizumab during 6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2010.