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The Impact of Nebivolol Versus Metoprolol on Quality of Life

This study has been terminated.
(due to slow enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01441570
First Posted: September 27, 2011
Last Update Posted: April 20, 2017
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.
Collaborators:
Forest Laboratories
Lahey Clinic
Information provided by (Responsible Party):
Steven Gabardi, Brigham and Women's Hospital
Results First Submitted: October 31, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Transplant; Failure, Kidney
Hypertension
Interventions: Drug: Nebivolol
Drug: Metoprolol succinate

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Nebivolol Nebivolol: Subject will take nebivolol daily for 12 weeks.
Metoprolol Succinate Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.

Participant Flow:   Overall Study
    Nebivolol   Metoprolol Succinate
STARTED   6   5 
COMPLETED   6   5 
NOT COMPLETED   0   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
Nebivolol Nebivolol: Subject will take nebivolol daily for 12 weeks.
Metoprolol Succinate Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
Total Total of all reporting groups

Baseline Measures
   Nebivolol   Metoprolol Succinate   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   5   11 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      6 100.0%      5 100.0%      11 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  50.0%      4  80.0%      7  63.6% 
Male      3  50.0%      1  20.0%      4  36.4% 
Region of Enrollment 
[Units: Participants]
     
United States   6   5   11 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Quality of Life   [ Time Frame: 12 weeks; Baseline scores were measured at the Initial Screening/Enrollment Visit (Visit 1 - beginning of week 1); Follow-Up scores were measured at the End of the Study (Visit 2 – End of week 12) ]

2.  Secondary:   Blood Pressure   [ Time Frame: 12 weeks ]


  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
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  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: Dr. Steven Gabardi
Organization: Brigham and Women's Hospital
phone: 617-732-7658
e-mail: sgabardi@partners.org



Responsible Party: Steven Gabardi, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01441570     History of Changes
Other Study ID Numbers: 2011P001638
First Submitted: September 26, 2011
First Posted: September 27, 2011
Results First Submitted: October 31, 2016
Results First Posted: April 20, 2017
Last Update Posted: April 20, 2017