Comparison of 2 Beta Blocker Drugs on Peripheral Arterial Disease in Patients With High Blood Pressure (ENCOMPASS)

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01499134
First received: October 24, 2011
Last updated: December 2, 2014
Last verified: December 2014
Results First Received: July 29, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Peripheral Artery Disease
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 1 to 4 capsules daily

nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing).

Metoprolol Succinate

metoprolol 1 to 4 capsules daily

Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing).


Participant Flow:   Overall Study
    Nebivolol     Metoprolol Succinate  
STARTED     9     8  
COMPLETED     9     7  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 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.
Original sample size for pilot study was fixed at 40 subjects. Lagging enrollment necessitated completion at 17 subjects.

Reporting Groups
  Description
Nebivolol

nebivolol 1 to 4 capsules daily

nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing).

Metoprolol Succinate

metoprolol 1 to 4 capsules daily

Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing).

Total Total of all reporting groups

Baseline Measures
    Nebivolol     Metoprolol Succinate     Total  
Number of Participants  
[units: participants]
  9     8     17  
Age  
[units: years]
Mean (Standard Deviation)
  66  (8)     65  (8)     66  (8)  
Gender  
[units: participants]
     
Female     7     2     9  
Male     2     6     8  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     9     8     17  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     5     3     8  
White     4     5     9  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     9     8     17  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Peak Walking Time (PWT)   [ Time Frame: Baseline PWT is measured at the time of enrollment and again at the final study visit at 26 weeks. ]

2.  Secondary:   Ankle-brachial Index (ABI)   [ Time Frame: Baseline ABI is measured at the time of enrollment and again at the final study visit at 26 weeks ]

3.  Secondary:   Claudication Onset Time (COT)   [ Time Frame: Baseline COT is measured at the time of enrollment and again at the final study visit at 26 weeks. ]

4.  Secondary:   Walking Impairment Questionnaire (WIQ) - Change Calf Pain   [ Time Frame: Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks. ]

5.  Secondary:   Walking Impairment Questionnaire (WIQ) - Change in Buttock Pain   [ Time Frame: Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks. ]

6.  Secondary:   Walking Impairment Questionnaire (WIQ) - Change in WIQ Distance Score   [ Time Frame: Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks. ]

7.  Secondary:   Walking Impairment Questionnaire (WIQ) - Change in WIQ Speed Score   [ Time Frame: Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks. ]

8.  Secondary:   Walking Impairment Questionnaire (WIQ) - Change in WIQ Stairs Score   [ Time Frame: Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Danielle Duffy MD
Organization: Thomas Jefferson University
phone: 215 955 5050
e-mail: Danielle.Duffy@jefferson.edu


No publications provided


Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01499134     History of Changes
Other Study ID Numbers: 11C.18
Study First Received: October 24, 2011
Results First Received: July 29, 2014
Last Updated: December 2, 2014
Health Authority: United States: Food and Drug Administration