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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2011

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Nebivolol
    • Nebivolol 5 mg daily for 2 weeks, then 5 or 10 mg daily for 2 weeks
  • Active Comparator: Lisinopril
    • 20 mg once daily for 2 weeks, then 20 or 40 mg once daily for 2 weeks

Clinical Trial Outcome Measures

Primary Measures

  • The primary endpoint of the study will be changes in sitting systolic and diastolic blood pressure at the crossover and final visits.
    • Time Frame: 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 Measures

  • The secondary endpoint of the study will be changes in heart rate at the end of the crossover and final visits.
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Mississippi Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zachery Somers, PharmD – University of Mississippi Medical Center

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.