HypertensionNCT01076140
Blood Pressure Effects of Nebivolol Versus Lisinopril in New Onset or Worsening Hypertension Induced by Bevacizumab
A study testing Nebivolol and Lisinopril in people with Hypertension, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to directly compare the blood pressure (hypertension) reduction effects of lisinopril and nebivolol in patients who develop new onset or worsening hypertension while treated with bevacizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Nebivolol and Lisinopril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Aug 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients currently treated at the University of Mississippi Medical Center Oncology Clinic
- Patient is being treated with bevacizumab either alone or in combination with other agents for cancer
- Patient blood pressure is >140 mmHg (systolic) or > 90 mmHg (diastolic), either treated or untreated with medications for hypertension
- Patients may be currently on medications for hypertension (other than Beta blocker, ACEI, or ARB); these will be continued at the same dose throughout the study
- Patients should be > 18 years of age
- Patients receiving bevacizumab therapy approximately every 2 weeks
Who cannot join
- History of ACEI or ARB induced angioedema or idiopathic/hereditary angioedema
- Patient currently treated with a Beta blocker, ACEI, or ARB or have a history of intolerance to a medication in any of these classes
- Hyperkalemia, defined as a potassium value of >5 mEq/L
- Pregnancy or breastfeeding
- Severe renal impairment (eGFR <30 mL/min)
- Moderate hepatic impairment as identified by physician
Show all 13Show fewer
- Currently taking CYP2D6 inducers (rifampin, carbamazepine or dexamethasone) or inhibitors (bupropion, fluoxetine, paroxetine, duloxetine, etc.)
- History of clinically significant EKG abnormality which would contraindicate beta blocker use
- Recent stroke (<6 months)
- Recent myocardial infarction (<6 months)
- Congestive heart failure
- Severe asthma or COPD
- Diagnosed obstructive sleep apnea
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: Comparative Blood Pressure Effects of Nebivolol Versus Lisinopril in Patients With New Onset or Exacerbated Hypertension Induced by Bevacizumab: a Crossover Study
The purpose of this study is to directly compare the blood pressure (hypertension) reduction effects of lisinopril and nebivolol in patients who develop new onset or worsening hypertension while treated with bevacizumab.
- Conditions
- Hypertension
- Being tested
- Nebivolol, Lisinopril
- Keywords
- Hypertension as a result of bevacizumab therapy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NebivololDrug
Nebivolol 5 or 10 mg tablets daily for 4 weeks. Lisinopril 20 or 40 mg daily for 4 weeks
LisinoprilDrug
Nebivolol 5 or 10 mg tablets daily for 4 weeks. Lisinopril 20 or 40 mg daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Nebivolol | Active comparator | Nebivolol 5 mg daily for 2 weeks, then 5 or 10 mg daily for 2 weeks Receives: Drug: Nebivolol |
| Lisinopril | Active comparator | 20 mg once daily for 2 weeks, then 20 or 40 mg once daily for 2 weeks Receives: Drug: Lisinopril |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study will be changes in sitting systolic and diastolic blood pressure at the crossover and final visits.
Patients will be treated with both nebivolol or lisinopril for a period of 4 weeks, and then crossover to the opposite medication for an additional 4 weeks.
Measured: 8 weeks
Secondary outcomes (1)
The secondary endpoint of the study will be changes in heart rate at the end of the crossover and final visits.
Patients will be treated with both nebivolol or lisinopril for a period of 4 weeks, and then crossover to the opposite medication for an additional 4 weeks.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2011 (estimated)
- Study completionAug 2011 (estimated)
Why it stopped: No participants enrolled
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zachery Somers, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076140
- Sponsor's protocol ID
- 2009-0222
- Status last verified
- Apr 2012
- First submitted
- 24 Feb 2010
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Blood Pressure Effects of Nebivolol Versus Lisinopril in Patients With New Onset or Exacerbated Hypertension Induced by Bevacizumab: a Crossover Study
- ClinicalTrials.gov ID
- NCT01076140
- Acronym / sponsor ID
- 2009-0222
- Conditions
- Hypertension
- Keywords
- Hypertension as a result of bevacizumab therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 25 Feb 2010 (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.
The purpose of this study is to directly compare the blood pressure (hypertension) reduction effects of lisinopril and nebivolol in patients who develop new onset or worsening hypertension while treated with bevacizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebivolol | Active comparator | Drug: NebivololNebivolol 5 mg daily for 2 weeks, then 5 or 10 mg daily for 2 weeks |
| Lisinopril | Active comparator | Drug: Lisinopril20 mg once daily for 2 weeks, then 20 or 40 mg once daily for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients currently treated at the University of Mississippi Medical Center Oncology Clinic
- Patient is being treated with bevacizumab either alone or in combination with other agents for cancer
- Patient blood pressure is >140 mmHg (systolic) or > 90 mmHg (diastolic), either treated or untreated with medications for hypertension
- Patients may be currently on medications for hypertension (other than Beta blocker, ACEI, or ARB); these will be continued at the same dose throughout the study
- Patients should be > 18 years of age
Key exclusion criteria (13 listed)
- History of ACEI or ARB induced angioedema or idiopathic/hereditary angioedema
- Patient currently treated with a Beta blocker, ACEI, or ARB or have a history of intolerance to a medication in any of these classes
- Hyperkalemia, defined as a potassium value of >5 mEq/L
- Pregnancy or breastfeeding
- Severe renal impairment (eGFR <30 mL/min)
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 |
|---|---|---|
| NebivololNebivolol 5 or 10 mg tablets daily for 4 weeks. Lisinopril 20 or 40 mg daily for 4 weeks | Drug | Nebivolol |
| LisinoprilNebivolol 5 or 10 mg tablets daily for 4 weeks. Lisinopril 20 or 40 mg daily for 4 weeks | Drug | Lisinopril |
Primary outcome
The primary endpoint of the study will be changes in sitting systolic and diastolic blood pressure at the crossover and final visits.
Time frame: 8 weeks
Patients will be treated with both nebivolol or lisinopril for a period of 4 weeks, and then crossover to the opposite medication for an additional 4 weeks.
1 secondary outcome
The secondary endpoint of the study will be changes in heart rate at the end of the crossover and final visits.
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nebivolol and Lisinopril in people with Hypertension, run by University of Mississippi Medical Center 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 13 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: withdrawn, as of the sponsor's last update on 6 Apr 2012. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
The primary endpoint of the study will be changes in sitting systolic and diastolic blood pressure at the crossover and final visits. (time frame: 8 weeks). 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 6 Apr 2012.