Comparing the Effects of Two Beta Blockers,Metoprolol and Nebivolol,on Ambulatory Blood Pressure and Basal Metabolic Rate

This study has been terminated.
(Difficulty with recruiting willing participants.)
Sponsor:
Information provided by (Responsible Party):
Deborah Minor, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT00849810
First received: February 2, 2009
Last updated: March 18, 2013
Last verified: March 2013
Results First Received: March 18, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Metoprolol
Drug: Nebivolol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From 11/2008-4/2009, 472 patient were prescribed metoprolol succinate. During screening, metoprolol succinate was discontinued in 87 patients and 177 were excluded (obstacles to visits, competency issues). A national shortage of metoprolol succinate caused discontinuation in mant patients. One patient was enrolled and completed the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
N/A

Reporting Groups
  Description
Metoprolol to Nebivolol

Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.

Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg.


Participant Flow:   Overall Study
    Metoprolol to Nebivolol  
STARTED     1  
COMPLETED     1  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Metoprolol to Nebivolol

Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.

Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg.


Baseline Measures
    Metoprolol to Nebivolol  
Number of Participants  
[units: participants]
  1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     0  
Gender  
[units: participants]
 
Female     1  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     1  



  Outcome Measures

1.  Primary:   Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure.   [ Time Frame: 4 weeks (pre- and post-treatment) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Professor of Medicine
Organization: University of Mississippi Medical Center
phone: 601-984-5600
e-mail: DMinor@umc.edu


No publications provided


Responsible Party: Deborah Minor, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00849810     History of Changes
Other Study ID Numbers: 2009-0002
Study First Received: February 2, 2009
Results First Received: March 18, 2013
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board