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

This study has been withdrawn prior to enrollment.
(No participants enrolled)
Sponsor:
Information provided by (Responsible Party):
Zachery Somers, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01076140
First received: February 24, 2010
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Hypertension
Drug: Nebivolol
Drug: Lisinopril

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Blood Pressure Effects of Nebivolol Versus Lisinopril in Patients With New Onset or Exacerbated Hypertension Induced by Bevacizumab: a Crossover Study

Resource links provided by NLM:


Further study details as provided by University of Mississippi Medical Center:

Primary Outcome 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 0
Study Start Date: February 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nebivolol
Nebivolol 5 mg daily for 2 weeks, then 5 or 10 mg daily for 2 weeks
Drug: Nebivolol
Nebivolol 5 or 10 mg tablets daily for 4 weeks. Lisinopril 20 or 40 mg daily for 4 weeks
Active Comparator: Lisinopril
20 mg once daily for 2 weeks, then 20 or 40 mg once daily for 2 weeks
Drug: Lisinopril
Nebivolol 5 or 10 mg tablets daily for 4 weeks. Lisinopril 20 or 40 mg daily for 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076140

Locations
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
  More Information

No publications provided

Responsible Party: Zachery Somers, PharmD, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01076140     History of Changes
Other Study ID Numbers: 2009-0222
Study First Received: February 24, 2010
Last Updated: April 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:
Hypertension as a result of bevacizumab therapy

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lisinopril
Nebivolol
Bevacizumab
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 24, 2014