Trial Outcomes & Findings for The Effect of Nebivolol on Endothelial Dysfunction in African Americans With Hypertension (NCT NCT01049009)
NCT ID: NCT01049009
Last Updated: 2017-04-11
Results Overview
Forearm blood flow measured by venous occlusion plethysmography at rest, after administration of N(G)-monomethyl-L-arginine (L-NMMA) and tetraethylammonium chloride (TEA), after administration of L-NMMA, TEA, and acetylcholine, and after administration of L-NMMA, TEA, and exercise. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.
COMPLETED
PHASE4
91 participants
12 weeks
2017-04-11
Participant Flow
Subjects recruited from the general medical clinics of The Emory Clinic, Emory University Hospital, and Grady Memorial Hospital between January 2010 through January 2012.
91 subjects were enrolled but 47 subjects were withdrawn prior to group assignment due to various factors, which included eligibility criteria, lost to follow-up, and withdrawal by subject.
Participant milestones
| Measure |
Nebivolol/Metoprolol XL
Subjects are randomized to Nebivolol 5mg and titrate to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration subjects will cross over to Metoprolol XL 50mg and titrate to Metoprolol XL 100mg two weeks after cross over.
|
Metoprolol XL/Nebivolol
Subjects are randomized to Metoprolol XL 50mg and titrate to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration subjects will cross over to Nebivolol 5mg and titrate to Nebivolol 10mg two weeks after cross over.
|
|---|---|---|
|
Treatment Period 1 (12 Weeks)
STARTED
|
23
|
21
|
|
Treatment Period 1 (12 Weeks)
COMPLETED
|
21
|
18
|
|
Treatment Period 1 (12 Weeks)
NOT COMPLETED
|
2
|
3
|
|
Treatment Period 2 (12 Weeks)
STARTED
|
21
|
18
|
|
Treatment Period 2 (12 Weeks)
COMPLETED
|
11
|
8
|
|
Treatment Period 2 (12 Weeks)
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
| Measure |
Nebivolol/Metoprolol XL
Subjects are randomized to Nebivolol 5mg and titrate to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration subjects will cross over to Metoprolol XL 50mg and titrate to Metoprolol XL 100mg two weeks after cross over.
|
Metoprolol XL/Nebivolol
Subjects are randomized to Metoprolol XL 50mg and titrate to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration subjects will cross over to Nebivolol 5mg and titrate to Nebivolol 10mg two weeks after cross over.
|
|---|---|---|
|
Treatment Period 1 (12 Weeks)
Protocol Violation
|
2
|
2
|
|
Treatment Period 1 (12 Weeks)
Lost to Follow-up
|
0
|
1
|
|
Treatment Period 2 (12 Weeks)
Lost to Follow-up
|
2
|
3
|
|
Treatment Period 2 (12 Weeks)
Protocol Violation
|
8
|
7
|
Baseline Characteristics
The Effect of Nebivolol on Endothelial Dysfunction in African Americans With Hypertension
Baseline characteristics by cohort
| Measure |
Nebivolol/Metoprolol XL
n=11 Participants
Subjects were randomized to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after cross over.
|
Metoprolol XL/Nebivolol
n=8 Participants
Subjects were randomized to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after cross over.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksForearm blood flow measured by venous occlusion plethysmography at rest, after administration of N(G)-monomethyl-L-arginine (L-NMMA) and tetraethylammonium chloride (TEA), after administration of L-NMMA, TEA, and acetylcholine, and after administration of L-NMMA, TEA, and exercise. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.
Outcome measures
| Measure |
Nebivolol/Metoprolol XL
n=11 Participants
Subjects were randomized to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after cross over.
|
Metoprolol XL/Nebivolol
n=8 Participants
Subjects were randomized to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after cross over.
|
|---|---|---|
|
Endothelial Function Measured by Forearm Blood Flow (FBF) at 12 Weeks
At rest
|
2.739 mL/100 mL/min
Standard Deviation 1.365
|
2.679 mL/100 mL/min
Standard Deviation .0901
|
|
Endothelial Function Measured by Forearm Blood Flow (FBF) at 12 Weeks
L-NMMA+TEA
|
1.963 mL/100 mL/min
Standard Deviation 0.968
|
2.221 mL/100 mL/min
Standard Deviation 0.630
|
|
Endothelial Function Measured by Forearm Blood Flow (FBF) at 12 Weeks
L-NMMA+TEA+ACh
|
5.376 mL/100 mL/min
Standard Deviation 3.362
|
7.562 mL/100 mL/min
Standard Deviation 4.358
|
|
Endothelial Function Measured by Forearm Blood Flow (FBF) at 12 Weeks
L-NMMA+TEA+exercise
|
7.377 mL/100 mL/min
Standard Deviation 2.754
|
11.574 mL/100 mL/min
Standard Deviation 4.716
|
PRIMARY outcome
Timeframe: 24 weeksForearm blood flow measured by venous occlusion plethysmography at rest, after administration of N(G)-monomethyl-L-arginine (L-NMMA) and tetraethylammonium chloride (TEA), after administration of L-NMMA, TEA, and acetylcholine, and after administration of L-NMMA, TEA, and exercise. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.
Outcome measures
| Measure |
Nebivolol/Metoprolol XL
n=11 Participants
Subjects were randomized to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after cross over.
|
Metoprolol XL/Nebivolol
n=8 Participants
Subjects were randomized to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after cross over.
|
|---|---|---|
|
Endothelial Function Measured by Forearm Blood Flow (FBF) at 24 Weeks
L-NMMA+TEA+ACh
|
7.158 mL/100 mL/min
Standard Deviation 4.875
|
7.534 mL/100 mL/min
Standard Deviation 4.523
|
|
Endothelial Function Measured by Forearm Blood Flow (FBF) at 24 Weeks
At rest
|
3.066 mL/100 mL/min
Standard Deviation 1.469
|
2.968 mL/100 mL/min
Standard Deviation 1.164
|
|
Endothelial Function Measured by Forearm Blood Flow (FBF) at 24 Weeks
L-NMMA+TEA
|
2.457 mL/100 mL/min
Standard Deviation 1.549
|
2.287 mL/100 mL/min
Standard Deviation 0.693
|
|
Endothelial Function Measured by Forearm Blood Flow (FBF) at 24 Weeks
L-NMMA+TEA+exercise
|
9.589 mL/100 mL/min
Standard Deviation 3.550
|
10.395 mL/100 mL/min
Standard Deviation 2.687
|
Adverse Events
Nebivolol/Metoprolol XL
Metoprolol XL/Nebivolol
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Arshed A. Quyyumi
Emory University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place