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

Not Applicable

Withdrawn

• Conditions: Hypertension
• Interventions: Drug: Nebivolol; Drug: Lisinopril

• Registration Number: NCT01076140
• Lead Sponsor: University of Mississippi Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-24
• Study First Submitted QC: 2010-02-24
• Study First Posted: 2010-02-25
• Primary Completion: 2011-01
• Study Completion: 2011-08
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-05
• Last Update Posted: 2012-04-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nebivolol	Nebivolol	Nebivolol 5 mg daily for 2 weeks, then 5 or 10 mg daily for 2 weeks
Lisinopril	Lisinopril	20 mg once daily for 2 weeks, then 20 or 40 mg once daily for 2 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States