Coronary Artery Disease, Hypertension
Conditions
Keywords
carvedilol, Coreg (TM), hypertension, blood pressure, coronary artery disease, Nebivolol, BYSTOLIC (TM)
Brief summary
This study is being done to see if the blood pressure lowering effect of an approved drug nebivolol is comparable to that of another approved drug carvedilol for the treatment of hypertension in patients who have coronary artery disease.
Interventions
DRUGNebivolol
Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration once daily
DRUGCarvedilol
Encapsulated Carvedilol 12.5 mg, 25 mg, 50 mg total daily dosage, oral administration twice daily
Sponsors
Forest Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female ambulatory outpatients 18 to 85 of age at screening * Coronary artery disease as defined by: status post myocardial infarction (heart attack) greater than 14 days post event with no upper time limit (and followed by stress testing with additional imaging (echocardiographic or nuclear) within the 12 months prior to enrollment) and/or angiographic evidence of one or more major coronary arteries narrowing of greater than 50% and/or a history of percutaneous or surgical coronary revascularization greater than 4 months after that procedure at the time of enrollment. * Qualifying blood pressure criteria for study entry and for randomization * Willing to adhere to exercise stress (treadmill) tests
Exclusion criteria
* Unstable angina within 7 days of screening * Potential coronary surgical/intervention within the next 6 months * Have any form of secondary hypertension * Have a history of hypersensitivity to nebivolol, metoprolol, carvedilol, or any beta blocker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral Diastolic Blood Pressure (DBP) | 18 weeks post initiation of randomized treatment | Peripheral diastolic blood pressure (DBP) at post-baseline (visit 13, week 18) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral Systolic Blood Pressure (SBP) | 18 weeks post initiation of randomized treatment | Peripheral systolic blood pressure (SBP) at visit 13 (week 18) |
| Proportion of Patients With Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18 | 18 weeks post-treatment | Proportion of Patients with Peripheral SBP \<140 mm Hg and DBP \<90 mm Hg at Week 18 |
| Left Ventricular Ejection Fraction (LVEF) (%) at Week 18 | 18 weeks post-treatment | Left ventricular ejection fraction (LVEF) (%) at Week 18 |
Countries
United States
Participant flow
Recruitment details
The recruitment period was April 2008 to May 2009 at 35 US locations.
Pre-assignment details
All patients went through a 4-week, single blind, metoprolol run-in phase before randomization.
Participants by arm
| Arm | Count |
|---|---|
| Nebivolol Encapsulated Nebivolol | 21 |
| Carvedilol Encapsulated Carvedilol | 18 |
| Total | 39 |
Baseline characteristics
| Characteristic | Carvedilol | Nebivolol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 9 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 12 Participants | 21 Participants |
| Age Continuous | 66.6 years STANDARD_DEVIATION 10.3 | 60.6 years STANDARD_DEVIATION 10.5 | 63.4 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment United States | 18 participants | 21 participants | 39 participants |
| Sex: Female, Male Female | 6 Participants | 1 Participants | 7 Participants |
| Sex: Female, Male Male | 12 Participants | 20 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 21 | 10 / 18 | 1 / 12 | 1 / 11 |
| serious Total, serious adverse events | 1 / 21 | 0 / 18 | 0 / 12 | 0 / 11 |
Outcome results
Primary
Peripheral Diastolic Blood Pressure (DBP)
Peripheral diastolic blood pressure (DBP) at post-baseline (visit 13, week 18)
Time frame: 18 weeks post initiation of randomized treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nebivolol | Peripheral Diastolic Blood Pressure (DBP) | Baseline | 81.1 mmHg | Standard Error 1.7 |
| Nebivolol | Peripheral Diastolic Blood Pressure (DBP) | Post-baseline | 78.0 mmHg | Standard Error 2.4 |
| Carvedilol | Peripheral Diastolic Blood Pressure (DBP) | Baseline | 78.2 mmHg | Standard Error 1.8 |
| Carvedilol | Peripheral Diastolic Blood Pressure (DBP) | Post-baseline | 79.3 mmHg | Standard Error 2.6 |
Secondary
Left Ventricular Ejection Fraction (LVEF) (%) at Week 18
Left ventricular ejection fraction (LVEF) (%) at Week 18
Time frame: 18 weeks post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nebivolol | Left Ventricular Ejection Fraction (LVEF) (%) at Week 18 | Baseline | 61.43 percentage | Standard Error 0.562 |
| Nebivolol | Left Ventricular Ejection Fraction (LVEF) (%) at Week 18 | Post baseline | 61.93 percentage | Standard Error 0.503 |
| Carvedilol | Left Ventricular Ejection Fraction (LVEF) (%) at Week 18 | Baseline | 60.442 percentage | Standard Error 1.125 |
| Carvedilol | Left Ventricular Ejection Fraction (LVEF) (%) at Week 18 | Post baseline | 60.775 percentage | Standard Error 0.614 |
Secondary
Peripheral Systolic Blood Pressure (SBP)
Peripheral systolic blood pressure (SBP) at visit 13 (week 18)
Time frame: 18 weeks post initiation of randomized treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nebivolol | Peripheral Systolic Blood Pressure (SBP) | Baseline | 135.1 mmHg | Standard Error 2.5 |
| Nebivolol | Peripheral Systolic Blood Pressure (SBP) | Post-Baseline | 129.6 mmHg | Standard Error 3.7 |
| Carvedilol | Peripheral Systolic Blood Pressure (SBP) | Baseline | 136.9 mmHg | Standard Error 2.4 |
| Carvedilol | Peripheral Systolic Blood Pressure (SBP) | Post-Baseline | 137.3 mmHg | Standard Error 4.4 |
Secondary
Proportion of Patients With Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18
Proportion of Patients with Peripheral SBP \<140 mm Hg and DBP \<90 mm Hg at Week 18
Time frame: 18 weeks post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nebivolol | Proportion of Patients With Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18 | 11 participants |
| Carvedilol | Proportion of Patients With Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18 | 5 participants |