Trial Outcomes & Findings for Efficacy and Safety of Nebivolol (Added to Lisinopril or Losartan) in Hypertensive Patients (NCT NCT00734630)
NCT ID: NCT00734630
Last Updated: 2011-04-26
Results Overview
Change from Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12, Last Observation Carried Forward (LOCF).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
491 participants
Primary outcome timeframe
From baseline Visit 5 (Week 0) to Visit 10 (Week 12)
Results posted on
2011-04-26
Participant Flow
Recruitment occured from August 2008 through November 2009 at 76 US sites.
Placebo washout phase was required for patients currently on anti-hypertensives at screening followed by a losartan or lisinopril run-in phase before assignment to Placebo or Nebivolol arms. Patients who were untreated at screening started the study at the open-label lead-in phase.
Participant milestones
| Measure |
Nebivolol
Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
|
Placebo
Matching placebo tablets, oral administration
|
|---|---|---|
|
Overall Study
STARTED
|
258
|
233
|
|
Overall Study
COMPLETED
|
229
|
200
|
|
Overall Study
NOT COMPLETED
|
29
|
33
|
Reasons for withdrawal
| Measure |
Nebivolol
Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
|
Placebo
Matching placebo tablets, oral administration
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
4
|
4
|
|
Overall Study
Withdrawal by Subject
|
7
|
9
|
|
Overall Study
Lost to Follow-up
|
13
|
7
|
|
Overall Study
Protocol Violation
|
0
|
3
|
|
Overall Study
Inclusion/Exclusion criteria not met
|
0
|
1
|
|
Overall Study
Adverse Event
|
3
|
6
|
|
Overall Study
Randomized in Error
|
0
|
1
|
|
Overall Study
Tested Positive for Illegal Drug Use
|
1
|
1
|
|
Overall Study
Poor Compliance
|
1
|
1
|
Baseline Characteristics
Efficacy and Safety of Nebivolol (Added to Lisinopril or Losartan) in Hypertensive Patients
Baseline characteristics by cohort
| Measure |
Nebivolol
n=258 Participants
Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
|
Placebo
n=233 Participants
Matching placebo tablets, oral administration
|
Total
n=491 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
52.1 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
53.8 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
52.9 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Age, Customized
Between 18 and 65 Years
|
229 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
430 Participants
n=5 Participants
|
|
Age, Customized
≥65 years
|
29 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
154 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
295 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
258 participants
n=5 Participants
|
233 participants
n=7 Participants
|
491 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline Visit 5 (Week 0) to Visit 10 (Week 12)Change from Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12, Last Observation Carried Forward (LOCF).
Outcome measures
| Measure |
Nebivolol
n=256 Participants
Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
|
Placebo
n=232 Participants
Matching placebo tablets, oral administration
|
|---|---|---|
|
Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12
|
-10.1 mmHG
Standard Deviation 16.9
|
-7.3 mmHG
Standard Deviation 15.9
|
SECONDARY outcome
Timeframe: From baseline Visit 5 (Week 0) to Visit 10 (Week 12)Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).
Outcome measures
| Measure |
Nebivolol
n=256 Participants
Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
|
Placebo
n=232 Participants
Matching placebo tablets, oral administration
|
|---|---|---|
|
Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12
|
-7.8 mmHG
Standard Deviation 10.1
|
-3.5 mmHG
Standard Deviation 10.6
|
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=258 participants at risk
Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
|
Placebo
n=233 participants at risk
Matching placebo tablets, oral administration
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/258 • Adverse event data was collected for a period of 21 months, from August 2008 to May 2010.
3 additional patients had a Serious Adverse Event(SAE), 1 instance of Coronary Artery Stenosis during the single-blind washout phase(SBWP), 1 instance of Myocardial Infarction during the open-label lead-in phase and 1 instance of deep vein thrombosis during the SBWP. The first 2 patients were not randomized. The 3rd patient was assigned placebo.
|
0.43%
1/233 • Adverse event data was collected for a period of 21 months, from August 2008 to May 2010.
3 additional patients had a Serious Adverse Event(SAE), 1 instance of Coronary Artery Stenosis during the single-blind washout phase(SBWP), 1 instance of Myocardial Infarction during the open-label lead-in phase and 1 instance of deep vein thrombosis during the SBWP. The first 2 patients were not randomized. The 3rd patient was assigned placebo.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/258 • Adverse event data was collected for a period of 21 months, from August 2008 to May 2010.
3 additional patients had a Serious Adverse Event(SAE), 1 instance of Coronary Artery Stenosis during the single-blind washout phase(SBWP), 1 instance of Myocardial Infarction during the open-label lead-in phase and 1 instance of deep vein thrombosis during the SBWP. The first 2 patients were not randomized. The 3rd patient was assigned placebo.
|
0.43%
1/233 • Adverse event data was collected for a period of 21 months, from August 2008 to May 2010.
3 additional patients had a Serious Adverse Event(SAE), 1 instance of Coronary Artery Stenosis during the single-blind washout phase(SBWP), 1 instance of Myocardial Infarction during the open-label lead-in phase and 1 instance of deep vein thrombosis during the SBWP. The first 2 patients were not randomized. The 3rd patient was assigned placebo.
|
|
Infections and infestations
Cellulitis
|
0.39%
1/258 • Adverse event data was collected for a period of 21 months, from August 2008 to May 2010.
3 additional patients had a Serious Adverse Event(SAE), 1 instance of Coronary Artery Stenosis during the single-blind washout phase(SBWP), 1 instance of Myocardial Infarction during the open-label lead-in phase and 1 instance of deep vein thrombosis during the SBWP. The first 2 patients were not randomized. The 3rd patient was assigned placebo.
|
0.00%
0/233 • Adverse event data was collected for a period of 21 months, from August 2008 to May 2010.
3 additional patients had a Serious Adverse Event(SAE), 1 instance of Coronary Artery Stenosis during the single-blind washout phase(SBWP), 1 instance of Myocardial Infarction during the open-label lead-in phase and 1 instance of deep vein thrombosis during the SBWP. The first 2 patients were not randomized. The 3rd patient was assigned placebo.
|
|
Infections and infestations
Acute pancreatitis
|
0.00%
0/258 • Adverse event data was collected for a period of 21 months, from August 2008 to May 2010.
3 additional patients had a Serious Adverse Event(SAE), 1 instance of Coronary Artery Stenosis during the single-blind washout phase(SBWP), 1 instance of Myocardial Infarction during the open-label lead-in phase and 1 instance of deep vein thrombosis during the SBWP. The first 2 patients were not randomized. The 3rd patient was assigned placebo.
|
0.43%
1/233 • Adverse event data was collected for a period of 21 months, from August 2008 to May 2010.
3 additional patients had a Serious Adverse Event(SAE), 1 instance of Coronary Artery Stenosis during the single-blind washout phase(SBWP), 1 instance of Myocardial Infarction during the open-label lead-in phase and 1 instance of deep vein thrombosis during the SBWP. The first 2 patients were not randomized. The 3rd patient was assigned placebo.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/258 • Adverse event data was collected for a period of 21 months, from August 2008 to May 2010.
3 additional patients had a Serious Adverse Event(SAE), 1 instance of Coronary Artery Stenosis during the single-blind washout phase(SBWP), 1 instance of Myocardial Infarction during the open-label lead-in phase and 1 instance of deep vein thrombosis during the SBWP. The first 2 patients were not randomized. The 3rd patient was assigned placebo.
|
0.43%
1/233 • Adverse event data was collected for a period of 21 months, from August 2008 to May 2010.
3 additional patients had a Serious Adverse Event(SAE), 1 instance of Coronary Artery Stenosis during the single-blind washout phase(SBWP), 1 instance of Myocardial Infarction during the open-label lead-in phase and 1 instance of deep vein thrombosis during the SBWP. The first 2 patients were not randomized. The 3rd patient was assigned placebo.
|
Other adverse events
Adverse event data not reported
Additional Information
Noah Rosenberg , MD, Exec. Dir, Clin Dev, Cardiovascular and Metabolism
Forest Laboratories, Inc.
Phone: 2014278000
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