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Comparison of Nebivolol and Metoprolol With Exercise and Angiotensin II in Hypertensive Patients

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ClinicalTrials.gov Identifier: NCT01502787
Recruitment Status : Completed
First Posted : January 2, 2012
Results First Posted : December 31, 2014
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Hypertension
Interventions Drug: Metoprolol succinate
Drug: Nebivolol
Procedure: Forearm blood flow
Procedure: Microneurography
Procedure: Rhythmic handgrip exercise
Procedure: Lower body negative pressure
Drug: Angiotensin II
Enrollment 46
Recruitment Details 25 subjects were screened but failed to meet inclusion criteria and were not included in treatment groups
Pre-assignment Details  
Arm/Group Title Metoprolol First Then Nebivolol Nebivolol First, Then Metoprolol
Hide Arm/Group Description

The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.

Metoprolol succinate: The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.

The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
Period Title: Overall Study
Started 11 10
Completed 11 10
Not Completed 0 0
Arm/Group Title All Participants
Hide Arm/Group Description The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period , there will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants
54  (13.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
7
  33.3%
Male
14
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants
21
1.Primary Outcome
Title Forearm Blood Flow
Hide Description [Not Specified]
Time Frame 12 weeks after each specified medication
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Intervention Metoprolol: 12 Weeks Second Intervention Nebivolol: 24 Weeks
Hide Arm/Group Description:
The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks.
The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: ml/min
96  (1) 105  (13)
2.Secondary Outcome
Title Blood Pressure During Exercise
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Initial Treatment With Metoprolol Initial Treatment With Nebivolol
Hide Arm/Group Description:

The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.

Metoprolol succinate: The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.

The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.

Nebivolol: The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: mmHg
101  (3) 103  (3)
3.Secondary Outcome
Title Blood Pressure During Angiotensin II Infusion
Hide Description [Not Specified]
Time Frame 12 weeks after initiation of metoprolol
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metoprolol Nebivolol
Hide Arm/Group Description:
Angiotensin II: blood pressure was measured at baseline and during intravenous infusion of Angiotensin II at the dose of 1, 2, and 3 ng/kg/min for 15 minutes at each dose.
Angiotensin II: blood pressure was measured at baseline and during intravenous infusion of Angiotensin II at the dose of 1, 2, and 3 ng/kg/min for 15 minutes at each dose.
Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: mmHg
114  (3) 113  (3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metoprolol 21 Subjects Nebivolol 21 Subjects
Hide Arm/Group Description The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
All-Cause Mortality
Metoprolol 21 Subjects Nebivolol 21 Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Metoprolol 21 Subjects Nebivolol 21 Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/21 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metoprolol 21 Subjects Nebivolol 21 Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/21 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wanpen Vongpatanasin
Organization: University of Texas Southwestern Medical Center
Phone: 2146458000
EMail: wanpen.vongpatanasin@utsouthwestern.edu
Publications:
Layout table for additonal information
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01502787    
Other Study ID Numbers: STU 062011-072
First Submitted: November 1, 2011
First Posted: January 2, 2012
Results First Submitted: December 2, 2014
Results First Posted: December 31, 2014
Last Update Posted: July 7, 2020