Trial Outcomes & Findings for Nebivolol Versus Metoprolol: Sodium Sensitivity (NCT NCT00992056)

NCT ID: NCT00992056

Last Updated: 2017-06-08

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 24 participants
• Primary outcome timeframe: Day 5, Day 10
• Results posted on: 2017-06-08

Participant Flow

Participant milestones

Measure	Nebivolol/Metoprolol Nebivolol 5 mg titrated to 10 mg then Metoprolol 50mg titrated to 100 mg.	Metoprolol/Nebivolol Metoprolol 50 mg titrated to 100 mg then nebivolol 5 mg titrated to 10 mg
Treatment Period 1 (6 Weeks) STARTED	12	12
Treatment Period 1 (6 Weeks) COMPLETED	11	10
Treatment Period 1 (6 Weeks) NOT COMPLETED	1	2
Washout Period (2 Weeks) STARTED	11	10
Washout Period (2 Weeks) COMPLETED	10	10
Washout Period (2 Weeks) NOT COMPLETED	1	0
Treatment Period 2 (6 Weeks) STARTED	10	10
Treatment Period 2 (6 Weeks) COMPLETED	10	10
Treatment Period 2 (6 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Nebivolol/Metoprolol Nebivolol 5 mg titrated to 10 mg then Metoprolol 50mg titrated to 100 mg.	Metoprolol/Nebivolol Metoprolol 50 mg titrated to 100 mg then nebivolol 5 mg titrated to 10 mg
Treatment Period 1 (6 Weeks) Withdrawal by Subject	1	2
Washout Period (2 Weeks) Physician Decision	1	0

Baseline Characteristics

Nebivolol Versus Metoprolol: Sodium Sensitivity

Baseline characteristics by cohort

Measure	Metoprolol/Nebivolol n=12 Participants Metoprolol 50 mg titrated to 100 mg then Nebivolol 5 mg titrated to 10 mg	Nebivolol/Metoprolol n=12 Participants Nebivolol 5 mg titrated to 10 mg then Metoprolol 50 mg titrated to 100 mg	Total n=24 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	10 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 5, Day 10

Population: 24 subjects were randomized. Three withdrew informed consent during the study. One was withdrawn during the washout period. One completed all phases of the study but had a faulty ABPM reading on the last determination

Outcome measures

Measure	Metoprolol n=19 Participants Participants who received Metoprolol 50 mg daily increased to 100 mg daily. If goal blood pressure (\<140/\<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 200 mg.	Nebivolol n=19 Participants Participants who received Nebivolol 5 mg daily increased to 10 mg daily. If goal blood pressure (\<140/\<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 20 mg.
Change in 24-hour Mean Systolic Blood Pressure by ABPM From Day 5 of Low Sodium to Day 10 of High Sodium	7.7 mmHg Interval 3.1 to 12.3	9.3 mmHg Interval 4.6 to 13.9

Adverse Events

Metoprolol

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Nebivolol

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Metoprolol n=24 participants at risk Participants who received Metoprolol 50 mg daily increased to 100 mg daily. If goal blood pressure (\<140/\<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 200 mg.	Nebivolol n=24 participants at risk Participants who received Nebivolol 5 mg daily increased to 10 mg daily. If goal blood pressure (\<140/\<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 20 mg.
Eye disorders Redness in eyes	8.3% 2/24 • Number of events 2	0.00% 0/24
Nervous system disorders Headache	0.00% 0/24	4.2% 1/24 • Number of events 1
Infections and infestations Common cold symptoms	0.00% 0/24	4.2% 1/24 • Number of events 1

Additional Information

Richard A Preston MD MSPH MBA

University of Miami

Phone: 305 243 5930

Email: rpreston@med.miami.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place