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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01076140
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : February 25, 2010
Last Update Posted : April 6, 2012
Sponsor:
Information provided by (Responsible Party):
Zachery Somers, University of Mississippi Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Nebivolol Drug: Lisinopril Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : February 2010
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : August 2011

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076140


Locations
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United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
More Information
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Responsible Party: Zachery Somers, PharmD, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01076140    
Other Study ID Numbers: 2009-0222
First Posted: February 25, 2010    Key Record Dates
Last Update Posted: April 6, 2012
Last Verified: April 2012
Keywords provided by Zachery Somers, University of Mississippi Medical Center:
Hypertension as a result of bevacizumab therapy
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Lisinopril
Nebivolol
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
 Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents