Approval Probability
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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...
Carvedilol controlled release/lisinopril is a combination treatment being developed by GSK plc for cardiovascular conditions. It pairs a controlled release formulation of carvedilol with lisinopril. It is in Phase 3 clinical development and is being studied in hypertension and congestive heart failure. It is an investigational combination and is not described as approved.
Carvedilol controlled release/lisinopril is being studied for two cardiovascular indications: hypertension and congestive heart failure. The completed Phase 3 trials enrolled adults with high blood pressure and with stable chronic heart failure. These are the indications under investigation for this combination.
The carvedilol component targets the alpha-1 adrenergic receptors ADRA1A, ADRA1B, and ADRA1D, and the beta-adrenergic receptors ADRB1, ADRB2, and ADRB3, acting as an antagonist at these receptors. Lisinopril is an ACE inhibitor. Together the combination is designed to act on these cardiovascular targets.
GSK plc, which trades under the ticker GSK, is the developer of carvedilol controlled release/lisinopril. The company sponsored the Phase 3 trials of the combination in hypertension and in congestive heart failure.
Carvedilol controlled release/lisinopril is in Phase 3 development. Three Phase 3 trials have been completed, and no active trials are currently listed. The program is investigational and is not described as approved.
Three completed Phase 3 trials studied this combination: NCT00624065 tested carvedilol CR plus lisinopril versus lisinopril plus placebo in hypertension, NCT00347360 was the COSMOS trial in hypertensive subjects, and NCT00323037 compared Coreg CR and Coreg IR effects on heart function in stable chronic heart failure. Total enrollment across these trials was 1,002 participants.
Carvedilol controlled release/lisinopril refers to the combination of a carvedilol controlled release formulation with lisinopril. Carvedilol controlled release alone is just the carvedilol component. The combination is also known as the carvedilol controlled release formulation, and it is the combination that GSK is developing in Phase 3.