Trial Outcomes & Findings for Nebivolol in Patients With Systolic Stage 2 Hypertension (NCT NCT01057251)
NCT ID: NCT01057251
Last Updated: 2012-01-11
Results Overview
Office blood pressure measured at trough by automatic oscillometric device.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
433 participants
Primary outcome timeframe
Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6)
Results posted on
2012-01-11
Participant Flow
Recruitment occured from March 2010 through October 2010 at 36 US sites.
A 4 week single-blind placebo washout phase was required for patients on anti-hypertensives at screening.
Participant milestones
| Measure |
Nebivolol
5 mg, titrated to 20 mg, once daily oral administration
|
Placebo
Dose-matched placebo, once daily oral administration
|
|---|---|---|
|
Overall Study
STARTED
|
290
|
143
|
|
Overall Study
COMPLETED
|
262
|
114
|
|
Overall Study
NOT COMPLETED
|
28
|
29
|
Reasons for withdrawal
| Measure |
Nebivolol
5 mg, titrated to 20 mg, once daily oral administration
|
Placebo
Dose-matched placebo, once daily oral administration
|
|---|---|---|
|
Overall Study
Did not meet InclusionExclusion criteria
|
4
|
2
|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
11
|
|
Overall Study
Protocol Violation
|
6
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
|
Overall Study
Lost to Follow-up
|
7
|
6
|
|
Overall Study
Other Reason
|
1
|
1
|
Baseline Characteristics
Nebivolol in Patients With Systolic Stage 2 Hypertension
Baseline characteristics by cohort
| Measure |
Nebivolol
n=290 Participants
5 mg, titrated to 20 mg, once daily oral administration
|
Placebo
n=142 Participants
Dose-matched placebo, once daily oral administration
|
Total
n=432 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
|
290 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
432 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
51.1 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
49.7 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
50.6 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
141 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
149 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
290 participants
n=5 Participants
|
142 participants
n=7 Participants
|
432 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6)Office blood pressure measured at trough by automatic oscillometric device.
Outcome measures
| Measure |
Nebivolol
n=288 Participants
5 mg, titrated to 20 mg, once daily oral administration
|
Placebo
n=139 Participants
Dose-matched placebo, once daily oral administration
|
|---|---|---|
|
Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy
|
-18.2 mm Hg
Standard Deviation 16.7
|
-12.3 mm Hg
Standard Deviation 17.7
|
PRIMARY outcome
Timeframe: Change from Baseline (Week 0) to Visit 4 (Week 6)Office blood pressure measured at trough by automatic oscillometric device.
Outcome measures
| Measure |
Nebivolol
n=288 Participants
5 mg, titrated to 20 mg, once daily oral administration
|
Placebo
n=139 Participants
Dose-matched placebo, once daily oral administration
|
|---|---|---|
|
Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy
|
-12.3 mm Hg
Standard Deviation 9.8
|
-5.7 mm Hg
Standard Deviation 11.4
|
Adverse Events
Nebivolol
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nebivolol
n=290 participants at risk
5 mg, titrated to 20 mg, once daily oral administration
|
Placebo
n=142 participants at risk
Dose-matched placebo, once daily oral administration
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
0.00%
0/290 • Adverse event data was collected for a period of 10 months, from March 2010 to January 2011.
|
0.70%
1/142 • Adverse event data was collected for a period of 10 months, from March 2010 to January 2011.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.34%
1/290 • Adverse event data was collected for a period of 10 months, from March 2010 to January 2011.
|
0.00%
0/142 • Adverse event data was collected for a period of 10 months, from March 2010 to January 2011.
|
|
General disorders
Chest Pain
|
0.00%
0/290 • Adverse event data was collected for a period of 10 months, from March 2010 to January 2011.
|
0.70%
1/142 • Adverse event data was collected for a period of 10 months, from March 2010 to January 2011.
|
|
Vascular disorders
Hypertension
|
0.00%
0/290 • Adverse event data was collected for a period of 10 months, from March 2010 to January 2011.
|
0.70%
1/142 • Adverse event data was collected for a period of 10 months, from March 2010 to January 2011.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/290 • Adverse event data was collected for a period of 10 months, from March 2010 to January 2011.
|
0.70%
1/142 • Adverse event data was collected for a period of 10 months, from March 2010 to January 2011.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.
- Publication restrictions are in place
Restriction type: OTHER