Treatment Induced HypertensionNCT00607477
Pilot Study of the Treatment of Vascular Endothelial Growth Factor(VEGF)Signaling Pathway Inhibitor-Induced Hypertension
A study testing Minoxidil and Hydralazine in people with Treatment Induced Hypertension, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to describe the length of time and extent of blood pressure response to minoxidil and hydralazine among cancer patients with difficult-to-treat vascular endothelial growth factor (VEGF) inhibitor treatment induced hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Induced Hypertension
- What is being tested?
- Minoxidil and Hydralazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jan 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ongoing treatment for malignancy by at the University of Chicago with any agent with recognized, specific inhibition of VEGF, VEGF-receptors, or downstream signaling molecules with the specific intention of inhibiting signaling of this pathway. These agents include but are not limited to: bevacizumab (Avastin™), sorafenib (Nexavar™), sunitinib (Sutent™), axitinib (AG-013736), and AZD 2171.
- Treatment of hypertension with at least 2 or more anti-hypertensive medications with blood pressure remaining greater than 140/90 mmHg.
- Stable management of other toxicities from the cancer treatments
- Expected to continue current cancer treatments for at least 4 weeks
- 18 years and older
- Ability to understand and the willingness to sign a written informed consent document prior to any study specific procedures.
Who cannot join
- Concurrent use of hematopoietic supportive treatment with erythropoietin or congeners.
- Current uncontrolled toxicities due to the cancer treatments.
- Patients having known contraindications to hydralazine or minoxidil therapy.
- Any readings of systolic blood pressure >200 mmHg or diastolic blood pressure >120 mmHg in the four (4) weeks prior to screening.
- Use of either minoxidil or hydralazine in the six (6) months prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of the Treatment of VEGF-Signaling Pathway Inhibitor-Induced Hypertension With Direct Vasodilators, Minoxidil and Hydralazine
The purpose of this study is to describe the length of time and extent of blood pressure response to minoxidil and hydralazine among cancer patients with difficult-to-treat vascular endothelial growth factor (VEGF) inhibitor treatment induced hypertension.
- Conditions
- Treatment Induced Hypertension
- Being tested
- Minoxidil, Hydralazine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinoxidilDrug
2.5 mg taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
HydralazineDrug
25 mg taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Minoxidil Receives: Drug: Minoxidil |
| 2 | Active comparator | Hydralazine Receives: Drug: Hydralazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of Change in Blood Pressure
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Study has been terminated due to poor accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Treatment Induced HypertensionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Maitland, M.D., Ph.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607477
- Sponsor's protocol ID
- 15386B
- Status last verified
- Jun 2014
- First submitted
- 22 Jan 2008
- Last updated
- 10 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Treatment of VEGF-Signaling Pathway Inhibitor-Induced Hypertension With Direct Vasodilators, Minoxidil and Hydralazine
- ClinicalTrials.gov ID
- NCT00607477
- Acronym / sponsor ID
- 15386B
- Conditions
- Treatment Induced Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study has been terminated due to poor accrual.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 5 Feb 2008 (estimated)
- Results
- Posted 16 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to describe the length of time and extent of blood pressure response to minoxidil and hydralazine among cancer patients with difficult-to-treat vascular endothelial growth factor (VEGF) inhibitor treatment induced hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: MinoxidilMinoxidil |
| 2 | Active comparator | Drug: HydralazineHydralazine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ongoing treatment for malignancy by at the University of Chicago with any agent with recognized, specific inhibition of VEGF, VEGF-receptors, or downstream signaling molecules with the specific intention of inhibiting signaling of this pathway. These agents include but are not limited to: bevacizumab (Avastin™), sorafenib (Nexavar™), sunitinib (Sutent™), axitinib (AG-013736), and AZD 2171.
- Treatment of hypertension with at least 2 or more anti-hypertensive medications with blood pressure remaining greater than 140/90 mmHg.
- Stable management of other toxicities from the cancer treatments
- Expected to continue current cancer treatments for at least 4 weeks
- 18 years and older
Key exclusion criteria (5 listed)
- Concurrent use of hematopoietic supportive treatment with erythropoietin or congeners.
- Current uncontrolled toxicities due to the cancer treatments.
- Patients having known contraindications to hydralazine or minoxidil therapy.
- Any readings of systolic blood pressure >200 mmHg or diastolic blood pressure >120 mmHg in the four (4) weeks prior to screening.
- Use of either minoxidil or hydralazine in the six (6) months prior to screening.
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 |
|---|---|---|
| Minoxidil2.5 mg taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week | Drug | 1 |
| Hydralazine25 mg taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week | Drug | 2 |
Primary outcome
Magnitude of Change in Blood Pressure
Time frame: 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael Maitland, M.D., Ph.D. principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minoxidil and Hydralazine in people with Treatment Induced Hypertension, run by University of Chicago at 1 site in United States.
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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 10 Jun 2014. 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 United States. 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?
Yes. Results are posted in the registry (first posted 16 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Magnitude of Change in Blood Pressure (time frame: 21 days). 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 10 Jun 2014.