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Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01415531
First received: August 10, 2011
Last updated: March 18, 2013
Last verified: March 2013
Results First Received: March 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Nebivolol
Drug: Placebo

  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
Patient recruitment occurred over a 4 month period from August 2011 to December 2011 at 76 study sites in the United States.

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
Placebo Dose-matched placebo
Nebivolol Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration

Participant Flow:   Overall Study
    Placebo     Nebivolol  
STARTED     214     427  
COMPLETED     189     390  
NOT COMPLETED     25     37  
Adverse Event                 7                 10  
Lack of Efficacy                 3                 2  
Protocol Violation                 0                 1  
Withdrawal by Subject                 5                 4  
Lost to Follow-up                 6                 14  
Lack of Compliance                 1                 4  
Other Reasons                 3                 2  



  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
Placebo Dose-matched placebo
Nebivolol Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
Total Total of all reporting groups

Baseline Measures
    Placebo     Nebivolol     Total  
Number of Participants  
[units: participants]
  214     427     641  
Age  
[units: years]
Mean ± Standard Deviation
     
18 to 54     46.0  ± 6.9     44.9  ± 6.9     45.3  ± 6.9  
Gender  
[units: participants]
     
Female     95     190     285  
Male     119     237     356  
Region of Enrollment  
[units: participants]
     
United States     214     427     641  



  Outcome Measures
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1.  Primary:   Trough Seated Diastolic Blood Pressure (DBP)   [ Time Frame: Change from Baseline to Week 8 ]

2.  Secondary:   Trough Seated Systolic Blood Pressure (SBP)   [ Time Frame: Change from Baseline to Week 8 ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Tatjana Lukic, MD, MSc
Organization: Forest Research Institute
phone: (201) 427-8649
e-mail: tanya.lukic@frx.com


No publications provided


Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01415531     History of Changes
Other Study ID Numbers: NEB-MD-28
Study First Received: August 10, 2011
Results First Received: March 18, 2013
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration