Blood Pressure Effects of Nebivolol Versus Lisinopril in New Onset or Worsening Hypertension Induced by Bevacizumab

Comparative Blood Pressure Effects of Nebivolol Versus Lisinopril in Patients With New Onset or Exacerbated Hypertension Induced by Bevacizumab: a Crossover Study

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01076140

Enrollment

Registered

2010-02-25

Start date

2010-02-28

Completion date

2011-08-31

Last updated

2012-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension as a result of bevacizumab therapy

Brief 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.

Interventions

DRUGNebivolol

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

DRUGLisinopril

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The primary endpoint of the study will be changes in sitting systolic and diastolic blood pressure at the crossover and final visits.	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.

Secondary

Measure	Time frame	Description
The secondary endpoint of the study will be changes in heart rate at the end of the crossover and final visits.	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026