Trial Outcomes & Findings for Treatment of OSA Associated Hypertension With Nebivolol or Hydrochlorothiazide (NCT NCT02710071)
NCT ID: NCT02710071
Last Updated: 2020-10-19
Results Overview
24-h Systolic Blood Pressure is the average of all 24-h Ambulatory Systolic Blood Pressure recordings. The Wake Period Systolic Blood Pressure is the average of all Systolic Blood Pressures recorded every 15 minutes during the wake period. The Sleep Period Systolic Blood pressure is the average of all Systolic Blood Pressures recorded every 30 minutes during the sleep period. 24-h Diastolic Blood Pressure is the average of all 24-h Ambulatory Diastolic Blood Pressure recordings. The Wake Period Diastolic Blood Pressure is the average of all Diastolic Blood Pressures recorded every 15 minutes during the wake period. The Sleep Period Diastolic Blood pressure is the average of all Diastolic Blood Pressures recorded every 30 minutes during the sleep period.
COMPLETED
PHASE4
41 participants
At the end of 2 weeks of placebo therapy, at the end of 6 weeks of Nebivolol therapy and at the end of 6 weeks of hydrochlorothiazide therapy.
2020-10-19
Participant Flow
41 of 405 participants were randomized. Of those not randomized, 364 did not meet inclusion criteria
Participant milestones
| Measure |
Placebo, Then Nebivolol, Then Hydrochlorothyazide
The participants first received Placebo for 2 weeks. They then received nebivolol 5 mg for 2 weeks followed by nebivolol 10 mg for 4 weeks. They then received hydrochlorothyazide 12.5 mg for 2 weeks followed by hydrochlorothyazide 25 mg for 4 weeks.
|
Placebo, Then Hydrochlorothiazide, Then Nebivolol
The participants first received Placebo for 2 weeks. They then received hydrochlorothyazide 12.5 mg for 2 weeks followed by hydrochlorothyazide 25 mg for 4 weeks. They then received nebivolol 5 mg for 2 weeks followed by nebivolol 10 mg for 4 weeks.
|
|---|---|---|
|
Placebo (2 Weeks).
STARTED
|
21
|
20
|
|
Placebo (2 Weeks).
COMPLETED
|
21
|
20
|
|
Placebo (2 Weeks).
NOT COMPLETED
|
0
|
0
|
|
First Intervention (6 Weeks).
STARTED
|
21
|
20
|
|
First Intervention (6 Weeks).
COMPLETED
|
18
|
16
|
|
First Intervention (6 Weeks).
NOT COMPLETED
|
3
|
4
|
|
Second Intervention (6 Weeks).
STARTED
|
18
|
16
|
|
Second Intervention (6 Weeks).
COMPLETED
|
17
|
14
|
|
Second Intervention (6 Weeks).
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo, Then Nebivolol, Then Hydrochlorothyazide
The participants first received Placebo for 2 weeks. They then received nebivolol 5 mg for 2 weeks followed by nebivolol 10 mg for 4 weeks. They then received hydrochlorothyazide 12.5 mg for 2 weeks followed by hydrochlorothyazide 25 mg for 4 weeks.
|
Placebo, Then Hydrochlorothiazide, Then Nebivolol
The participants first received Placebo for 2 weeks. They then received hydrochlorothyazide 12.5 mg for 2 weeks followed by hydrochlorothyazide 25 mg for 4 weeks. They then received nebivolol 5 mg for 2 weeks followed by nebivolol 10 mg for 4 weeks.
|
|---|---|---|
|
First Intervention (6 Weeks).
Withdrawal by Subject
|
3
|
4
|
|
Second Intervention (6 Weeks).
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Treatment of OSA Associated Hypertension With Nebivolol or Hydrochlorothiazide
Baseline characteristics by cohort
| Measure |
Placebo, Then Nebivolol, Then Hydrochlorothiazide
n=21 Participants
The participants first received Placebo for 2 weeks. They then received nebivolol 5 mg for 2 weeks followed by nebivolol 10 mg for 4 weeks. They then received hydrochlorothyazide 12.5 mg for 2 weeks followed by hydrochlorothyazide 25 mg for 4 weeks.
|
Placebo, Then Hydrochlorothiazide, Then Nebivolol
n=20 Participants
The participants first received Placebo for 2 weeks. They then received hydrochlorothyazide 12.5 mg for 2 weeks followed by hydrochlorothyazide 25 mg for 4 weeks. They then received nebivolol 5 mg for 2 weeks followed by nebivolol 10 mg for 4 weeks.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
37 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 10 • n=39 Participants
|
54 years
STANDARD_DEVIATION 11 • n=41 Participants
|
52 years
STANDARD_DEVIATION 11 • n=35 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
35 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=39 Participants
|
20 participants
n=41 Participants
|
41 participants
n=35 Participants
|
|
24-h Ambulatory Diastolic Blood Pressure
24-h diastolic blood pressure
|
86 mmHg
STANDARD_DEVIATION 11 • n=39 Participants
|
79 mmHg
STANDARD_DEVIATION 11 • n=41 Participants
|
82 mmHg
STANDARD_DEVIATION 10 • n=35 Participants
|
|
24-h Ambulatory Diastolic Blood Pressure
Wake diastolic blood pressure
|
89 mmHg
STANDARD_DEVIATION 11 • n=39 Participants
|
83 mmHg
STANDARD_DEVIATION 10 • n=41 Participants
|
86 mmHg
STANDARD_DEVIATION 10 • n=35 Participants
|
|
24-h Ambulatory Diastolic Blood Pressure
Sleep diastolic blood pressure
|
78 mmHg
STANDARD_DEVIATION 11 • n=39 Participants
|
74 mmHg
STANDARD_DEVIATION 10 • n=41 Participants
|
76 mmHg
STANDARD_DEVIATION 10 • n=35 Participants
|
PRIMARY outcome
Timeframe: At the end of 2 weeks of placebo therapy, at the end of 6 weeks of Nebivolol therapy and at the end of 6 weeks of hydrochlorothiazide therapy.Population: The overall Number of Analyzed Participants for primary outcome (27) differs from the Overall Number of Placebo (baseline) Participants (41) because 14 participants were excluded from the analysis due to either low quality of acquired data or due to missing data. Data Analysis was performed for the same 27 participants and for the each test period.
24-h Systolic Blood Pressure is the average of all 24-h Ambulatory Systolic Blood Pressure recordings. The Wake Period Systolic Blood Pressure is the average of all Systolic Blood Pressures recorded every 15 minutes during the wake period. The Sleep Period Systolic Blood pressure is the average of all Systolic Blood Pressures recorded every 30 minutes during the sleep period. 24-h Diastolic Blood Pressure is the average of all 24-h Ambulatory Diastolic Blood Pressure recordings. The Wake Period Diastolic Blood Pressure is the average of all Diastolic Blood Pressures recorded every 15 minutes during the wake period. The Sleep Period Diastolic Blood pressure is the average of all Diastolic Blood Pressures recorded every 30 minutes during the sleep period.
Outcome measures
| Measure |
Placebo
n=27 Participants
Placebo for 2 weeks.
|
Nebivolol
n=27 Participants
Nebivolol 5 mg for 2 weeks followed by nebivolol 10 mg for 4 weeks.
|
Hydrochlorothiazide
n=27 Participants
Hydrochlorothiazide 12.5 mg for 2 weeks followed by hydrochlorothiazide 25 mg for 4 weeks.
|
|---|---|---|---|
|
24-h, Wake and Sleep Period Systolic and Diastolic Blood Pressure
Wake systolic blood pressure
|
141 mmHg
Standard Error 3.1
|
135 mmHg
Standard Error 2.5
|
138 mmHg
Standard Error 3.1
|
|
24-h, Wake and Sleep Period Systolic and Diastolic Blood Pressure
Wake diastolic blood pressure
|
86 mmHg
Standard Error 1.9
|
81 mmHg
Standard Error 1.7
|
85 mmHg
Standard Error 2.1
|
|
24-h, Wake and Sleep Period Systolic and Diastolic Blood Pressure
Sleep systolic blood pressure
|
129 mmHg
Standard Error 3.2
|
123 mmHg
Standard Error 2.9
|
127 mmHg
Standard Error 3.0
|
|
24-h, Wake and Sleep Period Systolic and Diastolic Blood Pressure
Sleep diastolic blood pressure
|
76 mmHg
Standard Error 2.0
|
71 mmHg
Standard Error 2.02
|
75 mmHg
Standard Error 2.15
|
|
24-h, Wake and Sleep Period Systolic and Diastolic Blood Pressure
24-h systolic blood pressure
|
137 mmHg
Standard Error 3.1
|
130 mmHg
Standard Error 2.5
|
133 mmHg
Standard Error 2.9
|
|
24-h, Wake and Sleep Period Systolic and Diastolic Blood Pressure
24-h diastolic blood pressure
|
82 mmHg
Standard Error 1.9
|
77 mmHg
Standard Error 1.6
|
80 mmHg
Standard Error 1.9
|
Adverse Events
Placebo, Then Nebivolol, Then Hydrochlorothyazide
Placebo, Then Hydrochlorothyazide, Then Nebivolol
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael G. Ziegler, M.D.
University of California San Diego
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place