Trial Outcomes & Findings for Alternative in Beta Blocker Intolerance: The ABBI Trial (NCT NCT00893984)
NCT ID: NCT00893984
Last Updated: 2019-08-06
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
6 participants
Primary outcome timeframe
30 Days
Results posted on
2019-08-06
Participant Flow
Participant milestones
| Measure |
Nebivolol
Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
Nebivolol: Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alternative in Beta Blocker Intolerance: The ABBI Trial
Baseline characteristics by cohort
| Measure |
Nebivolol
n=6 Participants
Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
Nebivolol: Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 30 DaysOutcome measures
| Measure |
Nebivolol
n=6 Participants
Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
Nebivolol: Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
|
|---|---|
|
Number of Participants With Intolerance of Bystolic, Measured by Side Effect(s) That Lead to Discontinuance of Bystolic by the Patient and/or the Physician
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 DaysOutcome measures
| Measure |
Nebivolol
n=6 Participants
Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
Nebivolol: Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
|
|---|---|
|
Number of Participants With Termination of Bystolic Stratified by Reason
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 DaysOutcome measures
| Measure |
Nebivolol
n=6 Participants
Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
Nebivolol: Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
|
|---|---|
|
Incidence of Same Symptom Stopping Bystolic as Previous Beta Blocker
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 DaysMild symptoms include weight gain, edema, and headaches
Outcome measures
| Measure |
Nebivolol
n=6 Participants
Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
Nebivolol: Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
|
|---|---|
|
Number of Participants With Mild Symptoms
|
1 participants
|
Adverse Events
Nebivolol
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nebivolol
n=6 participants at risk
Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
Nebivolol: Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
|
|---|---|
|
Cardiac disorders
Weight Gain/Edema
|
16.7%
1/6 • Number of events 1 • Adverse event information collected out to 30 days
|
|
General disorders
Headache
|
16.7%
1/6 • Number of events 1 • Adverse event information collected out to 30 days
|
Additional Information
Chief Medical Officer
Minneapolis Heart Institute Foundation
Phone: 612-863-3900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place