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Trial record 64 of 228 for:    EDN1

Nebivolol and the Endothelin (ET)-1 System (NETS)

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ClinicalTrials.gov Identifier: NCT01395329
Recruitment Status : Completed
First Posted : July 15, 2011
Results First Posted : December 6, 2018
Last Update Posted : January 1, 2019
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Christopher DeSouza, University of Colorado, Boulder

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Other
Conditions Prehypertension
Hypertension
Interventions Drug: Nebivolol
Drug: Metoprolol
Drug: Placebo
Other: Forearm Blood Flow (FBF) response to BQ-123 (100 mol/min)
Other: FBF response to BQ-123 (100 nmol/min)+BQ-788(50 nmol/min)
Other: FBF response to Acetylcholine
Other: FBF response to Sodium Nitroprusside
Other: FBF response to BQ-123+BQ-788+ACh
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nebivolol Metoprolol Placebo
Hide Arm/Group Description Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks
Period Title: Overall Study
Started 14 14 14
Completed 14 14 14
Not Completed 0 0 0
Arm/Group Title Nebivolol Metoprolol Placebo Total
Hide Arm/Group Description Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 14 14 14 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 14 participants 42 participants
<=18 years 0 0 0 0
Between 18 and 65 years 14 14 14 42
>=65 years 0 0 0 0
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 14 participants 42 participants
57  (5.3) 55  (4.1) 56  (5.9) 56  (5.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 14 participants 42 participants
Female 6 5 5 16
Male 8 9 9 26
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 14 participants 14 participants 14 participants 42 participants
14 14 14 42
1.Primary Outcome
Title Systolic Blood Pressure
Hide Description [Not Specified]
Time Frame Systolic blood pressure was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Before Nebivolol After Nebivolol Before Metoprolol After Metoprolol Before Placebo After Placebo
Hide Arm/Group Description:
Before randomization to Nebivolol
Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks
Before randomization to Metoprolol
Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks
Before randomization to placebo
Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks
Overall Number of Participants Analyzed 14 14 14 14 14 14
Mean (Standard Error)
Unit of Measure: mmHg
144  (6.6) 126  (7.8) 140  (6.1) 125  (9.3) 139  (4.9) 134  (8.3)
2.Primary Outcome
Title Diastolic Blood Pressure
Hide Description [Not Specified]
Time Frame Diastolic blood pressure was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Before Nebivolol After Nebivolol Before Metoprolol After Metoprolol Before Placebo After Placebo
Hide Arm/Group Description:
Before randomization to Nebivolol
Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks
Before randomization to Metoprolol
Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks
Before randomization to placebo
Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks
Overall Number of Participants Analyzed 14 14 14 14 14 14
Mean (Standard Error)
Unit of Measure: mmHg
89  (5.2) 77  (5.3) 90  (7.6) 77  (4.8) 86  (7.7) 83  (7.3)
3.Primary Outcome
Title Percent Change in Forearm Blood Flow (FBF) Response to BQ-123 (100 Nmol/Min)
Hide Description Forearm blood flow (FBF) was measured via strain-gauge venous occlusion plethysmography at rest and every 10 minutes thereafter for 60 minutes. The average percent change for before and after either drug or placebo was calculated as the FBF at (each time point-resting value)/resting value and multiplied by 100 to calculate the percent change. The baseline or resting value was measured before the start of each drug infusion.
Time Frame Forearm blood flow was measured at 0-60 minutes before the 12 week drug or placebo intervention and 0-60 minutes after the 12 week drug or placebo intervention.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Before Nebivolol After Nebivolol Before Metoprolol After Metoprolol Before Placebo After Placebo
Hide Arm/Group Description:
Before randomization to Nebivolol
Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks
Before randomization to Metoprolol
Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks
Before randomization to placebo
Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks
Overall Number of Participants Analyzed 14 14 14 14 14 14
Mean (Standard Error)
Unit of Measure: percent change from baseline
BQ-123 10 min 10.2  (2.6) -1.0  (1.7) 10.0  (3.7) 11.1  (2.8) 13.1  (4.6) 15.7  (3.0)
BQ-123 20 min 17.4  (3.3) 6.0  (3.3) 18.0  (4.7) 18.7  (3.2) 20.4  (3.1) 14.7  (3.9)
BQ-123 30 min 22.3  (5.1) -1.1  (3.3) 23.0  (4.6) 21.1  (4.8) 26.8  (5.1) 23.3  (4.5)
BQ-123 40 min 25.6  (6.3) 3.8  (3.2) 28.4  (4.9) 28.9  (3.8) 23.9  (4.3) 25.7  (3.9)
BQ-123 50 min 25.8  (4.6) 6.1  (3.6) 31.4  (5.9) 27.7  (4.8) 29.0  (5.6) 26.5  (4.5)
BQ-123 60 min 27.0  (6.4) 1.1  (4.5) 34.4  (5.7) 30.6  (5.5) 33.8  (5.3) 30.4  (3.7)
4.Primary Outcome
Title Percent Change in FBF Response to BQ-123 (100 Nmol/Min) + BQ-788 (50 Nmol/Min)
Hide Description Forearm blood flow (FBF) was measured via strain-gauge venous occlusion plethysmography at rest and every 10 minutes thereafter for 60 minutes. The average percent change for before and after either drug or placebo was calculated as the FBF at (each time point-resting value)/resting value and multiplied by 100 to calculate the percent change. The baseline or resting value was measured before the start of each drug infusion.
Time Frame Forearm blood flow was measured 0-120 minutes before the 12 week drug or placebo intervention and 0-120 minutes after the 12 week drug or placebo intervention.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Before Nebivolol After Nebivolol Before Metoprolol After Metoprolol Before Placebo After Placebo
Hide Arm/Group Description:
Before randomization to Nebivolol
Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks
Before randomization to Metoprolol
Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks
Before randomization to placebo
Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks
Overall Number of Participants Analyzed 14 14 14 14 14 14
Mean (Standard Error)
Unit of Measure: Percent change from baseline
BQ-123 10 min 10.2  (2.6) -1.0  (1.7) 10.0  (3.7) 11.1  (2.8) 13.1  (4.6) 15.7  (3.0)
BQ-123 20 min 17.4  (3.3) 6.0  (3.3) 18.0  (4.7) 18.7  (3.2) 20.4  (3.1) 14.7  (3.9)
BQ-123 30 min 22.3  (5.1) -1.1  (3.3) 23.0  (4.6) 21.1  (4.8) 26.8  (5.1) 23.3  (4.5)
BQ-123 40 min 25.6  (6.3) 3.8  (3.2) 28.4  (4.9) 28.9  (3.8) 23.9  (4.3) 25.7  (3.9)
BQ-123 50 min 25.8  (4.6) 6.1  (3.6) 31.4  (5.9) 27.7  (4.8) 29.0  (5.6) 26.5  (4.5)
BQ-123 60 min 27.0  (6.4) 1.1  (4.5) 34.4  (5.7) 30.6  (5.5) 33.8  (5.3) 30.4  (3.7)
BQ-123+BQ-788 70 min 44.0  (6.9) 9.2  (3.7) 33.2  (6.9) 37.8  (5.7) 37.5  (8.3) 38.0  (7.5)
BQ-123+BQ-788 80 min 41.3  (7.0) 16.1  (8.2) 44.7  (7.3) 32.2  (7.3) 42.6  (9.5) 45.0  (7.9)
BQ-123+BQ-788 90 min 39.5  (7.1) 21.8  (9.2) 49.8  (9.5) 47.4  (6.9) 46.4  (8.9) 47.1  (7.4)
BQ-123+BQ-788 100 min 47.4  (7.8) 22.3  (8.5) 47.5  (7.4) 42.0  (7.6) 57.1  (9.5) 53.4  (8.5)
BQ-123+BQ-788 110 min 47.6  (8.5) 18.9  (7.0) 57.8  (10.4) 48.1  (7.6) 57.8  (7.8) 52.8  (9.3)
BQ-123+BQ-788 120 min 57.6  (9.0) 20.4  (7.6) 64.6  (9.8) 55.4  (7.1) 57.9  (9.5) 49.5  (10.3)
5.Primary Outcome
Title FBF Response to Acetylcholine (ACh)
Hide Description FBF was measured via strain-gauge occlusion plethysmography at rest and in response to ACh (4.0, 8.0 and 16.0 ug/100 mL tissue/min) for 5 minutes at each dose. Flows during the last minute of rest and each drug dose were measured and the mean value reported.
Time Frame Forearm blood flow was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Before Nebivolol After Nebivolol Before Metoprolol After Metoprolol Before Placebo After Placebo
Hide Arm/Group Description:
Before randomization to Nebivolol
Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks
Before randomization to Metoprolol
Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks
Before randomization to placebo
Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks
Overall Number of Participants Analyzed 14 14 14 14 14 14
Mean (Standard Error)
Unit of Measure: mL/100 mL tissue/min
Baseline 5.2  (0.3) 4.9  (0.4) 5.3  (0.5) 5.6  (0.5) 4.8  (0.2) 5.1  (0.3)
ACh 4.0 12.1  (0.8) 13.9  (0.9) 12.4  (1.0) 12.0  (1.0) 11.4  (0.6) 13.2  (0.7)
ACh 8.0 12.7  (0.8) 15.0  (0.8) 13.1  (1.1) 13.2  (1.1) 12.0  (0.6) 13.7  (0.6)
ACh 16.0 13.3  (0.8) 16.4  (0.6) 13.8  (1.1) 14.1  (1.1) 12.7  (0.8) 13.9  (0.7)
6.Primary Outcome
Title FBF Response to Sodium Nitroprusside
Hide Description FBF was measured via strain-gauge occlusion plethysmography at rest and in response to sodium nitroprusside (1.0, 2.0 and 4.0 ug/100 mL tissue/min) for 5 minutes at each dose. Flows during the last minute of rest and each drug dose were measured and the mean value reported.
Time Frame Forearm blood flow was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Before Nebivolol After Nebivolol Before Metoprolol After Metoprolol Before Placebo After Placebo
Hide Arm/Group Description:
Before randomization to Nebivolol
Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks
Before randomization to Metoprolol
Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks
Before randomization to placebo
Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks
Overall Number of Participants Analyzed 14 14 14 14 14 14
Mean (Standard Error)
Unit of Measure: mL/100 mL tissue/min
Baseline 5.2  (0.4) 4.7  (0.3) 4.9  (0.3) 5.7  (0.5) 5.2  (0.3) 5.2  (0.3)
Sodium Nitroprusside 1.0 13.5  (1.2) 13.7  (1.0) 14.1  (1.3) 14.3  (1.2) 12.8  (0.7) 13.7  (0.8)
Sodium Nitroprusside 2.0 15.3  (1.3) 15.2  (1.0) 14.9  (1.3) 15.1  (1.1) 14.4  (0.8) 15.3  (0.8)
Sodium Nitroprusside 4.0 15.9  (1.2) 16.4  (1.1) 15.8  (1.3) 16.0  (1.0) 15.8  (0.8) 16.1  (0.9)
7.Primary Outcome
Title FBF Response to ACh in the Absence or Presence of Nonselective Endothelin A/B Blockade (BQ-123+BQ-788)
Hide Description FBF was measured via strain-gauge occlusion plethysmography at rest and in response to BQ-123+BQ-788 +ACh (4.0, 8.0 and 16.0 ug/100 mL tissue/min) for 5 minutes at each dose. Flows during the last minute of rest and each drug dose were measured and the mean value reported.
Time Frame Forearm blood flow was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Before Nebivolol After Nebivolol Before Metoprolol After Metoprolol Before Placebo After Placebo
Hide Arm/Group Description:
Before randomization to Nebivolol
Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks
Before randomization to Metoprolol
Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks
Before randomization to placebo
Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks
Overall Number of Participants Analyzed 14 14 14 14 14 14
Mean (Standard Error)
Unit of Measure: mL/100 mL tissue/min
Baseline 5.0  (0.3) 4.7  (0.3) 5.5  (0.4) 6.0  (0.5) 4.9  (0.2) 5.1  (0.3)
ACh 4.0 11.7  (0.8) 13.8  (0.9) 13.1  (1.1) 12.4  (1.1) 11.7  (0.6) 13.3  (0.7)
ACh 8.0 12.3  (0.7) 15.0  (0.7) 13.7  (1.2) 13.7  (1.2) 12.3  (0.7) 13.7  (0.7)
ACh 16.0 12.9  (0.7) 16.1  (0.5) 14.5  (1.2) 14.7  (1.2) 13.0  (0.8) 13.9  (0.8)
Baseline+BQ123/788 6.4  (0.5) 5.8  (0.7) 6.7  (0.4) 7.4  (0.7) 6.1  (0.4) 5.6  (0.4)
ACh 4.0+BQ-123/788 14.6  (0.7) 13.7  (0.9) 16.1  (1.3) 16.5  (1.3) 13.5  (1.0) 15.3  (0.9)
ACh 8.0+BQ-123/788 15.3  (0.7) 14.5  (0.8) 17.1  (1.2) 17.6  (1.2) 15.1  (0.9) 16.5  (0.9)
ACh 16.0+BQ-123/788 15.9  (0.6) 15.0  (0.7) 17.9  (1.3) 18.2  (1.2) 16.2  (0.9) 17.3  (1.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nebivolol Metoprolol Placebo
Hide Arm/Group Description Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks
All-Cause Mortality
Nebivolol Metoprolol Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%)   0/14 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Nebivolol Metoprolol Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nebivolol Metoprolol Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%)   0/14 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Christopher DeSouza
Organization: University of Colorado
Phone: 303-492-2988
EMail: desouzac@colorado.edu
Layout table for additonal information
Responsible Party: Christopher DeSouza, University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT01395329     History of Changes
Other Study ID Numbers: BYS-MD-57
First Submitted: June 9, 2011
First Posted: July 15, 2011
Results First Submitted: May 2, 2018
Results First Posted: December 6, 2018
Last Update Posted: January 1, 2019