Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Carvedilol CR capsules, carvedilol MR
Carvedilol · 3 trials · 3 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 | twice daily oral treatment in escalating dose |
| 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...