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Also known as Carvedilol CR capsules, carvedilol MR, Coreg, metoprolol
Carvedilol · 4 trials · 4 indications
LVMI was measured by MRI at Baseline and after 12 months of treatment/Month 12. A reduction in left ventricular mass, calculated as LVMI, of 5 g/m\^2 was assumed to be clinically meaningful. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.
Change in right ventricular ejection fraction is measured by cardiac magnetic resonance imaging, using the method of disks with the reading radiologist being blinded to before and after images. Cardiac magnetic resonance imaging was done at baseline and 6 months only
| Arm | Type | Description |
|---|---|---|
| Carvedilol CR | EXPERIMENTAL | Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release \[MR\].) |
| Atenolol | EXPERIMENTAL | Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. |
| Lisinopril | EXPERIMENTAL | Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. |
| carvedilol | EXPERIMENTAL | Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI |
| Subjects receiving treatment sequence AB | EXPERIMENTAL | Eligible subjects will receive treatment sequence AB; A= Placebo to match COREG CR 20 milligrams once daily plus lisinopril 10 milligrams once daily (Days 1-7). Placebo to match COREG CR 40 milligrams once daily plus lisinopril 10 milligrams once daily (Days 8-14). B=COREG CR 20 milligrams once daily plus lisinopril 10 milligrams once daily (Days 1-7). COREG CR 40 milligrams once daily plus lisinopril 10 milligrams once daily (Days 8-14). |
| Subjects receiving treatment sequence BA | EXPERIMENTAL | Eligible subjects will receive treatment sequence BA; B=COREG CR 20 milligrams once daily plus lisinopril 10 milligrams once daily (Days 1-7). COREG CR 40 milligrams once daily plus lisinopril 10 milligrams once daily (Days 8-14). A= Placebo to match COREG CR 20 milligrams once daily plus lisinopril 10 milligrams once daily (Days 1-7). Placebo to match COREG CR 40 milligrams once daily plus lisinopril 10 milligrams once daily (Days 8-14). |
| Name | Type | Description |
|---|---|---|
| carvedilol MR | DRUG | Study drug |
| atenolol | DRUG | Comparator |
| lisinopril | DRUG | Comparator |
| Carvedilol | DRUG | - |
| Carvedilol CR capsules | DRUG | The carvedilol micropump (COREG) CR cpsules will be available with doses of 20 milligrams and 40 milligrams administered orally once daily. |
| Placebo | DRUG | Placebo capsules to match each dose level will be provided. |
Inclusion criteria: * Stage 1 or Stage 2 hypertension. * Left ventricular hypertrophy. Exclusion criteria: * In atrial fibrillation. * Takes beta-blocker for MI (myocardial infarction) or arrhythmia. * Has uncontrolled diabetes, uncontrollable or symptomatic arrhythmias, unstable angina, second o...
Carvedilol is used in cardiovascular conditions including congestive heart failure, hypertension, hypertrophy of the left ventricle, and pulmonary arterial hypertension. It is a small molecule drug developed by GSK plc. Clinical studies have evaluated it in adults with these conditions, including a Phase 3 study in left ventricular hypertrophy and a Phase 3 study in congestive heart failure.
Carvedilol targets the alpha-1 adrenergic receptors ADRA1A, ADRA1B, and ADRA1D, and the beta-adrenergic receptors ADRB1, ADRB2, and ADRB3. It acts as an antagonist at these targets, meaning it blocks receptor activity. This combined alpha and beta receptor blockade underlies its use across cardiovascular indications such as heart failure and hypertension.
Carvedilol is developed by GSK plc, which trades under the ticker GSK. GSK is the company associated with the clinical development program for carvedilol across its cardiovascular indications, including congestive heart failure, hypertension, left ventricular hypertrophy, and pulmonary arterial hypertension.
Carvedilol has reached Phase 3 in its clinical development program. Phase 3 trials include NCT00129363, which evaluated twice daily oral carvedilol in congestive heart failure, and NCT00108082, the CLEVER study, which assessed carvedilol and left ventricular mass regression in left ventricular hypertrophy with 287 participants.
Carvedilol has been studied in completed trials including NCT00964678, a Phase 1 pilot study in pulmonary arterial hypertension with 10 participants, NCT00508365, a Phase 1 study of orthostatic hypotension in elderly hypertensives with 62 participants, NCT00129363, a Phase 3 heart failure study, and NCT00108082, the Phase 3 CLEVER study.
Carvedilol CR capsules and carvedilol MR are alternative names for carvedilol, referring to controlled-release and modified-release formulations of the same drug. Searches for these names refer to the same active agent, a small molecule developed by GSK plc that acts as an antagonist at alpha-1 and beta-adrenergic receptors.