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

University of Mississippi

Status: Withdrawn

Conditions: Hypertension

Treatments: Drug: Lisinopril; Drug: Nebivolol

Study type: Interventional

Funder types: Other

Identifiers

NCT01076140

2009-0222

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Nebivolol

Active Comparator group

Description:

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

Treatment:

Drug: Nebivolol

Lisinopril

Active Comparator group

Description:

20 mg once daily for 2 weeks, then 20 or 40 mg once daily for 2 weeks

Treatment:

Drug: Lisinopril