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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01076140
• Other study ID #: 2009-0222
• Status: Withdrawn
• Phase: N/A
• First received: February 24, 2010
• Last updated: April 5, 2012
• Start date: February 2010
• Est. completion date: August 2011

Study information

• Verified date: April 2012
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The secondary endpoint of the study will be changes in heart rate at the end of 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	Yes