Trial Outcomes & Findings for A Study on the Long-term Efficacy of Nebivolol After Withdrawal of Therapy (NCT NCT00785512)
NCT ID: NCT00785512
Last Updated: 2010-09-15
Results Overview
Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral diastolic blood pressure measured at drug trough.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
207 participants
Primary outcome timeframe
From baseline, week 0 (Visit 9) to week 4 (Visit 12)
Results posted on
2010-09-15
Participant Flow
The recruitment period was five months, from November 2008 through March 2009.
Patients went through a 4-5 week, single blind, placebo run-in/washout phase, followed by a 12 week single-blind active treatment phase with nebivolol before randomization
Participant milestones
| Measure |
Nebivolol
Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
|
Placebo
Matching placebo tablets, oral administration
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
105
|
|
Overall Study
COMPLETED
|
99
|
101
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Nebivolol
Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
|
Placebo
Matching placebo tablets, oral administration
|
|---|---|---|
|
Overall Study
Inclusion/Exclusion not meet
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Precedure Refused
|
0
|
0
|
|
Overall Study
IVRS Programing Error
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
|
Overall Study
Lack of compliance
|
0
|
1
|
Baseline Characteristics
A Study on the Long-term Efficacy of Nebivolol After Withdrawal of Therapy
Baseline characteristics by cohort
| Measure |
Nebivolol
n=102 Participants
Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
|
Placebo
n=105 Participants
Matching placebo tablets, oral administration
|
Total
n=207 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
Ages 18 to 64 years
|
86 participants
n=5 Participants
|
91 participants
n=7 Participants
|
177 participants
n=5 Participants
|
|
Age Categorical
>=65 years
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Age Continuous
|
52.6 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
52.9 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
52.8 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
102 participants
n=5 Participants
|
105 participants
n=7 Participants
|
207 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline, week 0 (Visit 9) to week 4 (Visit 12)Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral diastolic blood pressure measured at drug trough.
Outcome measures
| Measure |
Nebivolol
n=101 Participants
Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
|
Placebo
n=105 Participants
Matching placebo tablets, oral administration
|
|---|---|---|
|
Trough Sitting Diastolic Blood Pressure
Baseline
|
81.3 mm HG
Standard Deviation 7.2
|
81.1 mm HG
Standard Deviation 7.0
|
|
Trough Sitting Diastolic Blood Pressure
Change from baseline
|
1.8 mm HG
Standard Deviation 7.3
|
7.7 mm HG
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: From baseline, week 0 (Visit 9) to week 4 (Visit 12)Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral systolic blood pressure measured at drug trough.
Outcome measures
| Measure |
Nebivolol
n=101 Participants
Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
|
Placebo
n=105 Participants
Matching placebo tablets, oral administration
|
|---|---|---|
|
Trough Sitting Systolic Blood Pressure
Baseline
|
134.1 mm HG
Standard Deviation 12.5
|
134.4 mm HG
Standard Deviation 11.4
|
|
Trough Sitting Systolic Blood Pressure
Change from baseline
|
3.5 mm HG
Standard Deviation 12.3
|
7.6 mm HG
Standard Deviation 11.8
|
Adverse Events
Single-blind Nebivolol
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Nebivolol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single-blind Nebivolol
n=269 participants at risk
Pre-randomization 12 week nebivolol treatment.
|
Nebivolol
n=102 participants at risk
Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
|
Placebo
n=105 participants at risk
Matching placebo tablets, oral administration
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.37%
1/269 • Adverse event data was collected for a period of 9 months, from November 2008 to August 2009.
|
0.00%
0/102 • Adverse event data was collected for a period of 9 months, from November 2008 to August 2009.
|
0.00%
0/105 • Adverse event data was collected for a period of 9 months, from November 2008 to August 2009.
|
|
Infections and infestations
Pneumonia
|
0.37%
1/269 • Adverse event data was collected for a period of 9 months, from November 2008 to August 2009.
|
0.00%
0/102 • Adverse event data was collected for a period of 9 months, from November 2008 to August 2009.
|
0.00%
0/105 • Adverse event data was collected for a period of 9 months, from November 2008 to August 2009.
|
|
Infections and infestations
Sepsis
|
0.37%
1/269 • Adverse event data was collected for a period of 9 months, from November 2008 to August 2009.
|
0.00%
0/102 • Adverse event data was collected for a period of 9 months, from November 2008 to August 2009.
|
0.00%
0/105 • Adverse event data was collected for a period of 9 months, from November 2008 to August 2009.
|
Other adverse events
| Measure |
Single-blind Nebivolol
n=269 participants at risk
Pre-randomization 12 week nebivolol treatment.
|
Nebivolol
n=102 participants at risk
Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
|
Placebo
n=105 participants at risk
Matching placebo tablets, oral administration
|
|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
5.9%
16/269 • Adverse event data was collected for a period of 9 months, from November 2008 to August 2009.
|
0.00%
0/102 • Adverse event data was collected for a period of 9 months, from November 2008 to August 2009.
|
0.00%
0/105 • Adverse event data was collected for a period of 9 months, from November 2008 to August 2009.
|
|
Infections and infestations
Nasopharyngitis
|
5.2%
14/269 • Adverse event data was collected for a period of 9 months, from November 2008 to August 2009.
|
0.00%
0/102 • Adverse event data was collected for a period of 9 months, from November 2008 to August 2009.
|
0.00%
0/105 • Adverse event data was collected for a period of 9 months, from November 2008 to August 2009.
|
Additional Information
John Whalen, MD Executive Director of Clinical Development - Cardiovascular and Metabolism
Forest Laboratories
Phone: 1-201-427-8259
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor can review results communications prior to public release \& can embargo communications re: results for 60 days from time submitted to sponsor for review. PI shall not disclose sponsor's confidential information. Upon sponsor's request, PI shall delete any proprietary info \& shall not include raw data in the publication. On sponsor's request, PI shall delay submission for any pub while sponsor files patent applications. Any publication will give recognition to Sponsor's support.
- Publication restrictions are in place
Restriction type: OTHER