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Can Nebivolol Reverse Inappropriate Left Ventricular Mass in Hypertensive Patients?

This study has been terminated.
(Difficulty in identifying subjects satisfying the inclusion criteria.)
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Marek Belohlavek, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01605370
First received: May 22, 2012
Last updated: May 8, 2014
Last verified: May 2014
Results First Received: April 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: 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

Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.

Nebivolol: Nebivolol 2.5 mg once daily

Metoprolol Succinate

Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.

Metoprolol succinate: Metoprolol succinate 50 mg once daily


Participant Flow:   Overall Study
    Nebivolol     Metoprolol Succinate  
STARTED     1     0  
COMPLETED     0     0  
NOT COMPLETED     1     0  
Adverse Event                 1                 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.
The study was terminated early due to the difficulty in identifying subjects satisfying the inclusion criteria. Only 1 subject was enrolled.

Reporting Groups
  Description
Nebivolol

Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.

Nebivolol: Nebivolol 2.5 mg once daily

Metoprolol Succinate

Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.

Metoprolol succinate: Metoprolol succinate 50 mg once daily

Total Total of all reporting groups

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



  Outcome Measures

1.  Primary:   Change in Inappropriate Left Ventricular Mass (LVM)   [ Time Frame: baseline, 6 months ]


  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
The study was terminated early due to the difficulty in identifying subjects satisfying the inclusion criteria. Only 1 subject was enrolled.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Marek Belohlavek, M.D., Ph.D.
Organization: Mayo Clinic
phone: 408-301-6694
e-mail: belohlavek.marek@mayo.edu


No publications provided


Responsible Party: Marek Belohlavek, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01605370     History of Changes
Other Study ID Numbers: 11-007035
Study First Received: May 22, 2012
Results First Received: April 4, 2014
Last Updated: May 8, 2014
Health Authority: United States: Institutional Review Board