We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Can Nebivolol Reverse Inappropriate Left Ventricular Mass in Hypertensive Patients? (Inapprop)

This study has been terminated.
(Difficulty in identifying subjects satisfying the inclusion criteria.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01605370
First Posted: May 24, 2012
Last Update Posted: May 19, 2014
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.
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Marek Belohlavek, Mayo Clinic
Results First Submitted: April 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Nebivolol
Drug: Metoprolol succinate

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Hide Limitations and Caveats

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
  Hide More Information

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



Responsible Party: Marek Belohlavek, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01605370     History of Changes
Other Study ID Numbers: 11-007035
First Submitted: May 22, 2012
First Posted: May 24, 2012
Results First Submitted: April 4, 2014
Results First Posted: May 7, 2014
Last Update Posted: May 19, 2014



To Top