Trial Outcomes & Findings for A Study on the Efficacy and Safety of Nebivolol Monotherapy in Hispanic Hypertensive Patients (NCT NCT00770861)
NCT ID: NCT00770861
Last Updated: 2011-01-26
Results Overview
The primary efficacy parameter was the change from baseline in mean trough seated DBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated DBP value.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
277 participants
Primary outcome timeframe
From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)
Results posted on
2011-01-26
Participant Flow
The recruitment period was one year, from November 2008 to November 2009, occurring at 29 centers in the US and 3 centers in Puerto Rico.
All patients went through a 4 week, single blind, placebo run-in/washout phase before randomization.
Participant milestones
| Measure |
Nebivolol
Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; 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
|
141
|
136
|
|
Overall Study
COMPLETED
|
131
|
120
|
|
Overall Study
NOT COMPLETED
|
10
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study on the Efficacy and Safety of Nebivolol Monotherapy in Hispanic Hypertensive Patients
Baseline characteristics by cohort
| Measure |
Nebivolol
n=141 Participants
Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; 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=136 Participants
Matching placebo tablets, oral administration
|
Total
n=277 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
135 Participants
n=93 Participants
|
129 Participants
n=4 Participants
|
264 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Age Continuous
|
50.4 years
STANDARD_DEVIATION 8.7 • n=93 Participants
|
50.4 years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
50.4 years
STANDARD_DEVIATION 8.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
113 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=93 Participants
|
85 Participants
n=4 Participants
|
164 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
134 participants
n=93 Participants
|
131 participants
n=4 Participants
|
265 participants
n=27 Participants
|
|
Region of Enrollment
Puerto Rico
|
7 participants
n=93 Participants
|
5 participants
n=4 Participants
|
12 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)The primary efficacy parameter was the change from baseline in mean trough seated DBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated DBP value.
Outcome measures
| Measure |
Nebivolol
n=141 Participants
Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; 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=135 Participants
Matching placebo tablets, oral administration
|
|---|---|---|
|
Change From Baseline in Trough Seated DBP at Week 8(LOCF).
|
-11.1 mm Hg
Standard Deviation 8.8
|
-7.3 mm Hg
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)The secondary efficacy parameter was the change from baseline in mean trough seated SBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated SBP value.
Outcome measures
| Measure |
Nebivolol
n=141 Participants
Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; 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=135 Participants
Matching placebo tablets, oral administration
|
|---|---|---|
|
Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF).
|
-14.1 mm Hg
Standard Deviation 12.7
|
-9.3 mm Hg
Standard Deviation 13.0
|
Adverse Events
Nebivolol
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nebivolol
n=141 participants at risk
Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; 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=136 participants at risk
Matching placebo tablets, oral administration
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/141 • Adverse events data were collected for a period of thirteen months, from November 2008 to December 2009.
|
0.74%
1/136 • Adverse events data were collected for a period of thirteen months, from November 2008 to December 2009.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/141 • Adverse events data were collected for a period of thirteen months, from November 2008 to December 2009.
|
0.74%
1/136 • Adverse events data were collected for a period of thirteen months, from November 2008 to December 2009.
|
Other adverse events
| Measure |
Nebivolol
n=141 participants at risk
Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; 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=136 participants at risk
Matching placebo tablets, oral administration
|
|---|---|---|
|
Nervous system disorders
Headache
|
3.5%
5/141 • Adverse events data were collected for a period of thirteen months, from November 2008 to December 2009.
|
5.9%
8/136 • Adverse events data were collected for a period of thirteen months, from November 2008 to December 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