An Advanced Echocardiographic Evaluation of Nebivolol

This study has been terminated.
(Slow enrollment)
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Jack Rubinstein, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01206439
First received: April 2, 2010
Last updated: October 22, 2015
Last verified: October 2015
Results First Received: August 24, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Intervention: 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
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 5 or 10 mg, Oral, Daily

Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.

nebivolol: nebivolol 5 or 10 mg oral, daily


Participant Flow:   Overall Study
    Nebivolol 5 or 10 mg, Oral, Daily  
STARTED     2  
COMPLETED     1  
NOT COMPLETED     1  
subject did not meet inclusion criteria                 1  



  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 5 or 10 mg, Oral, Daily

Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.

nebivolol: nebivolol 5 or 10 mg oral, daily


Baseline Measures
    Nebivolol 5 or 10 mg, Oral, Daily  
Number of Participants  
[units: participants]
  1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  NA [1]
Gender  
[units: participants]
 
Female     0  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     1  
[1] Only 1 subject was enrolled. Statistics cannot be performed.



  Outcome Measures

1.  Primary:   Change in Systolic and Diastolic Myocardial Function   [ Time Frame: Baseline to day 180 ]

2.  Secondary:   Exercise Tolerance   [ Time Frame: Baseline to day 180. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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: Jack Rubinstein
Organization: University of Cincinnati
phone: 513-558-3062
e-mail: rubinsjk@ucmail.uc.edu


No publications provided


Responsible Party: Jack Rubinstein, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01206439     History of Changes
Other Study ID Numbers: UC- 09-12-31-04
Study First Received: April 2, 2010
Results First Received: August 24, 2015
Last Updated: October 22, 2015
Health Authority: United States: Institutional Review Board