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This study has been withdrawn prior to enrollment.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

History of Changes

Tracking Information
First Received Date ^ICMJE	February 24, 2010
Last Updated Date	April 5, 2012
Start Date ^ICMJE	February 2010
Estimated Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 24, 2010)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01076140 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 24, 2010)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Blood Pressure Effects of Nebivolol Versus Lisinopril in New Onset or Worsening Hypertension Induced by Bevacizumab
Official Title ^ICMJE	Comparative Blood Pressure Effects of Nebivolol Versus Lisinopril in Patients With New Onset or Exacerbated Hypertension Induced by Bevacizumab: a Crossover Study
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Hypertension
Intervention ^ICMJE	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
Study Arm (s)	Active Comparator: Nebivolol Nebivolol 5 mg daily for 2 weeks, then 5 or 10 mg daily for 2 weeks Intervention: Drug: Nebivolol Active Comparator: Lisinopril 20 mg once daily for 2 weeks, then 20 or 40 mg once daily for 2 weeks Intervention: Drug: Lisinopril
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Enrollment ^ICMJE	0
Estimated Completion Date	August 2011
Estimated Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01076140
Other Study ID Numbers ^ICMJE	2009-0222
Has Data Monitoring Committee	No
Responsible Party	Zachery Somers, University of Mississippi Medical Center
Study Sponsor ^ICMJE	University of Mississippi Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Mississippi Medical Center
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top