Trial Outcomes & Findings for Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years) (NCT NCT01415531)
NCT ID: NCT01415531
Last Updated: 2013-05-16
Results Overview
Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
641 participants
Primary outcome timeframe
Change from Baseline to Week 8
Results posted on
2013-05-16
Participant Flow
Patient recruitment occurred over a 4 month period from August 2011 to December 2011 at 76 study sites in the United States.
Participant milestones
| Measure |
Placebo
Dose-matched placebo
|
Nebivolol
Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
|
|---|---|---|
|
Overall Study
STARTED
|
214
|
427
|
|
Overall Study
COMPLETED
|
189
|
390
|
|
Overall Study
NOT COMPLETED
|
25
|
37
|
Reasons for withdrawal
| Measure |
Placebo
Dose-matched placebo
|
Nebivolol
Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
10
|
|
Overall Study
Lack of Efficacy
|
3
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
6
|
14
|
|
Overall Study
Lack of Compliance
|
1
|
4
|
|
Overall Study
Other Reasons
|
3
|
2
|
Baseline Characteristics
Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)
Baseline characteristics by cohort
| Measure |
Placebo
n=214 Participants
Dose-matched placebo
|
Nebivolol
n=427 Participants
Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
|
Total
n=641 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
18 to 54
|
46.0 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
44.9 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
45.3 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
285 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=5 Participants
|
237 Participants
n=7 Participants
|
356 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
214 participants
n=5 Participants
|
427 participants
n=7 Participants
|
641 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to Week 8Population: 641 patients were randomized to receive double-blind treatment. The Safety population consisted of 641 patients who received at least 1 dose of double-blind treatment. The Intent to Treat population (ITT) consisted of 634 patients who had at least 1 postbaseline seated diastolic blood pressure (DBP) assessment
Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.
Outcome measures
| Measure |
Placebo
n=211 Participants
Dose-matched placebo
|
Nebivolol
n=423 Participants
Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
|
|---|---|---|
|
Trough Seated Diastolic Blood Pressure (DBP)
|
-5.5 mmHG
Standard Deviation 9.5
|
-11.8 mmHG
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 8Population: 641 patients were randomized to receive double-blind treatment. The Safety population consisted of 641 patients who received at least 1 dose of double-blind treatment. The Intent to Treat population (ITT) consisted of 634 patients who had at least 1 postbaseline seated diastolic blood pressure (DBP) assessment
Change from baseline in mean seated trough cuff Systolic Blood Pressure (SBP) at Week 8 as measured by an Omron device. The secondary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.
Outcome measures
| Measure |
Placebo
n=211 Participants
Dose-matched placebo
|
Nebivolol
n=423 Participants
Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
|
|---|---|---|
|
Trough Seated Systolic Blood Pressure (SBP)
|
-5.5 mm Hg
Standard Deviation 13.9
|
-13.7 mm Hg
Standard Deviation 14.5
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths
Nebivolol
Serious events: 4 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=214 participants at risk
Dose-matched placebo
|
Nebivolol
n=427 participants at risk
Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
|
|---|---|---|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/214 • Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
|
0.23%
1/427 • Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/214 • Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
|
0.23%
1/427 • Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/214 • Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
|
0.23%
1/427 • Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.47%
1/214 • Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
|
0.00%
0/427 • Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.47%
1/214 • Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
|
0.00%
0/427 • Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.47%
1/214 • Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
|
0.00%
0/427 • Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.47%
1/214 • Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
|
0.00%
0/427 • Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.47%
1/214 • Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
|
0.00%
0/427 • Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/214 • Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
|
0.23%
1/427 • Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
|
Other adverse events
| Measure |
Placebo
n=214 participants at risk
Dose-matched placebo
|
Nebivolol
n=427 participants at risk
Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
4/214 • Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
|
5.4%
23/427 • Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
|
|
Nervous system disorders
Headache
|
7.9%
17/214 • Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
|
3.3%
14/427 • Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
|
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