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

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

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nebivolol

Nebivolol 5 mg daily for 2 weeks, then 5 or 10 mg daily for 2 weeks

Group Type ACTIVE_COMPARATOR

Nebivolol

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Lisinopril

Intervention Type DRUG

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

Intervention Type DRUG

Lisinopril

Nebivolol 5 or 10 mg tablets daily for 4 weeks. Lisinopril 20 or 40 mg daily for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Mississippi Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Zachery Somers

PharmD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Countries

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United States

Other Identifiers

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2009-0222

Identifier Type: -

Identifier Source: org_study_id

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