Blood Pressure Effects of Nebivolol Versus Lisinopril in New Onset or Worsening Hypertension Induced by Bevacizumab
NCT ID: NCT01076140
Last Updated: 2012-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2010-02-28
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Nebivolol
Nebivolol 5 mg daily for 2 weeks, then 5 or 10 mg daily for 2 weeks
Nebivolol
Nebivolol 5 or 10 mg tablets daily for 4 weeks. Lisinopril 20 or 40 mg daily for 4 weeks
Lisinopril
20 mg once daily for 2 weeks, then 20 or 40 mg once daily for 2 weeks
Lisinopril
Nebivolol 5 or 10 mg tablets daily for 4 weeks. Lisinopril 20 or 40 mg daily for 4 weeks
Interventions
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Nebivolol
Nebivolol 5 or 10 mg tablets daily for 4 weeks. Lisinopril 20 or 40 mg daily for 4 weeks
Lisinopril
Nebivolol 5 or 10 mg tablets daily for 4 weeks. Lisinopril 20 or 40 mg daily for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Mississippi Medical Center
OTHER
Responsible Party
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Zachery Somers
PharmD
Locations
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University of Mississippi Medical Center
Jackson, Mississippi, United States
Countries
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Other Identifiers
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2009-0222
Identifier Type: -
Identifier Source: org_study_id
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