Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as carvedilol controlled release formulation, carvedilol controlled release
carvedilol controlled release/lisinopril · 3 trials · 2 indications
Maintenance Visit 3 minus Baseline. Maintenance Visit 3 occurred 24 weeks after entry into the maintenance period. The maintenance period started after completion of a titration period of variable duration.
Sitting cuff blood pressure was calculated as the mean of three measurements taken approximately 2 minutes apart, and before the morning dose.
Ambulatory blood pressure monitoring (ABPM) was completed at Baseline and at the end of treatment/Week 6 or early withdrawal by standard electronic ABPM equipment worn by the subject for 24-hr of ambulatory activity. The 24 hr assessment period started at the time of the first reading and ended exactly 24 hr later on the following day. Data collected included mean diastolic blood pressure (DBP).
Trough ABPM was the average across 20-24 hr after dosing for each subject.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | - |
| 2 | ACTIVE_COMPARATOR | - |
| carvedilol CR + lisinopril | EXPERIMENTAL | - |
| lisinopril + placebo | ACTIVE_COMPARATOR | - |
| lisinopril | EXPERIMENTAL | lisinopril |
| carvedilol | EXPERIMENTAL | carvedilol controlled release formulation |
| Name | Type | Description |
|---|---|---|
| carvedilol controlled release | DRUG | Carvedilol controlled release (10, 20, 40 or 80 mg) and placebo taken in the morning. Two placebos taken in the evening. A total of 4 pills will be taken PO daily. |
| carvedilol immediate release | DRUG | Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily. |
| carvedilol controlled release/lisinopril | DRUG | carvedilol CR + lisinopril given as separate pills |
| lisinopril + placebo | DRUG | lisinopril plus placebo to match carvedilol CR |
| lisinopril | DRUG | - |
| carvedilol controlled release formulation | DRUG | - |
Inclusion Criteria: * Male or non-pregnant female * At least 18 years of age at the time informed consent is signed * Stable, chronic, mild to severe heart failure as defined as subjects with symptoms of heart failure who do not require IV diuretics, inotropes, or vasodilators or those that require...