Trial Outcomes & Findings for A Study Examining the Effects of Nebivolol Compared to Atenolol on Endothelial Function (NCT NCT01522950)
NCT ID: NCT01522950
Last Updated: 2020-07-17
Results Overview
Change in small artery elasticity (a marker for endothelial function) from baseline to 9 months after intervention initiation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
baseline, 9 months
Results posted on
2020-07-17
Participant Flow
Participant milestones
| Measure |
Nebivolol
5 mg, continue for 1 month; dose titration to 10 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
Nebivolol: 5 mg daily or 10 mg daily
|
Atenolol
25 mg, continue for 1 month; dose titration to 50 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
atenolol: 25 mg daily or 50 mg daily
|
Placebo
Continue for 1 month; dose titration to "high dose" placebo, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
placebo: one tablet daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
23
|
27
|
|
Overall Study
COMPLETED
|
20
|
18
|
22
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
5
|
Reasons for withdrawal
| Measure |
Nebivolol
5 mg, continue for 1 month; dose titration to 10 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
Nebivolol: 5 mg daily or 10 mg daily
|
Atenolol
25 mg, continue for 1 month; dose titration to 50 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
atenolol: 25 mg daily or 50 mg daily
|
Placebo
Continue for 1 month; dose titration to "high dose" placebo, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
placebo: one tablet daily
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
1
|
|
Overall Study
Adverse Event
|
3
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
2
|
|
Overall Study
Death
|
0
|
1
|
1
|
|
Overall Study
Study Medication Sensitivity
|
0
|
1
|
0
|
Baseline Characteristics
A Study Examining the Effects of Nebivolol Compared to Atenolol on Endothelial Function
Baseline characteristics by cohort
| Measure |
Nebivolol
n=20 Participants
5 mg, continue for 1 month; dose titration to 10 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
Nebivolol: 5 mg daily or 10 mg daily
|
Atenolol
n=18 Participants
25 mg, continue for 1 month; dose titration to 50 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
atenolol: 25 mg daily or 50 mg daily
|
Placebo
n=22 Participants
Continue for 1 month; dose titration to "high dose" placebo, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
placebo: one tablet daily
|
Total
n=60 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
50.8 years
STANDARD_DEVIATION 14 • n=7 Participants
|
54 years
STANDARD_DEVIATION 9 • n=5 Participants
|
50.7 years
STANDARD_DEVIATION 13.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
18 participants
n=7 Participants
|
22 participants
n=5 Participants
|
60 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline, 9 monthsChange in small artery elasticity (a marker for endothelial function) from baseline to 9 months after intervention initiation.
Outcome measures
| Measure |
Nebivolol
n=20 Participants
5 mg, continue for 1 month; dose titration to 10 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
Nebivolol: 5 mg daily or 10 mg daily
|
Atenolol
n=18 Participants
25 mg, continue for 1 month; dose titration to 50 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
atenolol: 25 mg daily or 50 mg daily
|
Placebo
n=22 Participants
Continue for 1 month; dose titration to "high dose" placebo, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
placebo: one tablet daily
|
|---|---|---|---|
|
Change in Small Artery Elasticity
|
2.4 (ml/mmHg × 100)
Standard Deviation 2.1
|
1.0 (ml/mmHg × 100)
Standard Deviation 2.1
|
0.4 (ml/mmHg × 100)
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: baseline, 9 monthsChange in large artery elasticity (a marker for endothelial function) from baseline to 9 months after intervention initiation.
Outcome measures
| Measure |
Nebivolol
n=20 Participants
5 mg, continue for 1 month; dose titration to 10 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
Nebivolol: 5 mg daily or 10 mg daily
|
Atenolol
n=18 Participants
25 mg, continue for 1 month; dose titration to 50 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
atenolol: 25 mg daily or 50 mg daily
|
Placebo
n=22 Participants
Continue for 1 month; dose titration to "high dose" placebo, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
placebo: one tablet daily
|
|---|---|---|---|
|
Change in Large Artery Elasticity
|
3.2 (ml/mmHg × 10)
Standard Deviation 5.4
|
2.9 (ml/mmHg × 10)
Standard Deviation 3.4
|
0.2 (ml/mmHg × 10)
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: baseline, 9 monthsChange in systolic blood pressure as measured by sphygmomanometer from baseline to 9 months after intervention initiation.
Outcome measures
| Measure |
Nebivolol
n=20 Participants
5 mg, continue for 1 month; dose titration to 10 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
Nebivolol: 5 mg daily or 10 mg daily
|
Atenolol
n=18 Participants
25 mg, continue for 1 month; dose titration to 50 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
atenolol: 25 mg daily or 50 mg daily
|
Placebo
n=22 Participants
Continue for 1 month; dose titration to "high dose" placebo, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
placebo: one tablet daily
|
|---|---|---|---|
|
Change in Systolic Blood Pressure
|
-9 mmHg
Standard Deviation 12.9
|
-13 mmHg
Standard Deviation 10.6
|
-3.2 mmHg
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: baseline, 9 monthsChange in diastolic blood pressure as measured by sphygmomanometer from baseline to 9 months after intervention initiation.
Outcome measures
| Measure |
Nebivolol
n=20 Participants
5 mg, continue for 1 month; dose titration to 10 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
Nebivolol: 5 mg daily or 10 mg daily
|
Atenolol
n=18 Participants
25 mg, continue for 1 month; dose titration to 50 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
atenolol: 25 mg daily or 50 mg daily
|
Placebo
n=22 Participants
Continue for 1 month; dose titration to "high dose" placebo, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
placebo: one tablet daily
|
|---|---|---|---|
|
Change in Diastolic Blood Pressure
|
-8.5 mmHg
Standard Deviation 10.1
|
-8.5 mmHg
Standard Deviation 8.9
|
-2.9 mmHg
Standard Deviation 6.7
|
Adverse Events
Nebivolol
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Atenolol
Serious events: 0 serious events
Other events: 4 other events
Deaths: 1 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nebivolol
n=20 participants at risk
5 mg, continue for 1 month; dose titration to 10 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
Nebivolol: 5 mg daily or 10 mg daily
|
Atenolol
n=18 participants at risk
25 mg, continue for 1 month; dose titration to 50 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
atenolol: 25 mg daily or 50 mg daily
|
Placebo
n=22 participants at risk
Continue for 1 month; dose titration to "high dose" placebo, continue for 8 months. Dose may be returned to initiation levels if side effects occur.
placebo: one tablet daily
|
|---|---|---|---|
|
General disorders
Fatigue
|
25.0%
5/20
|
11.1%
2/18
|
9.1%
2/22
|
|
General disorders
Headache
|
0.00%
0/20
|
0.00%
0/18
|
4.5%
1/22
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20
|
11.1%
2/18
|
4.5%
1/22
|
|
General disorders
Dizziness
|
0.00%
0/20
|
0.00%
0/18
|
4.5%
1/22
|
|
General disorders
Pruritus
|
0.00%
0/20
|
0.00%
0/18
|
4.5%
1/22
|
|
General disorders
Hypertension
|
0.00%
0/20
|
0.00%
0/18
|
4.5%
1/22
|
Additional Information
Jay N. Cohn, M.D., Professor of Medicine
University of Minnesota
Phone: 612.625.5646
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place