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

NCT01076140 | Withdrawn

• 1 other identifier: 2009-0222
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Hypertension as a result of bevacizumab therapy

Outcome Measures

Primary Outcomes (1)

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

  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.

  8 weeks

Secondary Outcomes (1)

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

  8 weeks

Study Arms (2)

Nebivolol

ACTIVE COMPARATOR

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

Drug: Nebivolol

Lisinopril

ACTIVE COMPARATOR

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

Drug: Lisinopril

Interventions

Nebivolol DRUG

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

Nebivolol

Lisinopril DRUG

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

Lisinopril

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Nebivolol; Lisinopril

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PharmD

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 25, 2010
• Study Start: February 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 6, 2012

Record last verified: 2012-04

Locations

US (1)