Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
bucindolol · 1 trial · 1 indication
Time-to-event is calculated as the date of the event minus the date of initiation of efficacy follow-up, with 1 added in order to include both the start date and end date of the interval. Cox's proportional hazards model will be used to calculate estimated hazard ratios and 95% confidence intervals. The calculations will be performed with the SAS PHREG procedure, with the stratification variables specified in the STRATA statement and the treatment group comparator and any covariates being examined specified in the MODEL statement. For the primary endpoint, the appropriateness of assuming proportional hazards will be explored by the graphing of log (-log(survival function)) over follow-up for each treatment group.
| Arm | Type | Description |
|---|---|---|
| bucindolol hydrochloride | EXPERIMENTAL | bucindolol hydrochloride (bucindolol) Participants were randomized (1:1) to blinded treatment with bucindolol or metoprolol and titrated weekly to target doses of 50 mg twice daily (BID; \< 75 kg) or 100 mg BID (≥ 75 kg) for bucindolol or 200 mg once daily (QD) for metoprolol. 84% of bucindolol participants attained target dose and 72% of metoprolol participants attained target dose. The lowest starting dose of bucindolol was 6.25 mg BID with weekly dose titrations to the weight-based target dose or to the maximum tolerated dose. The starting dose assigned was based on the patient's beta-blocker treatment prior to randomization. Capsules for titration were available in the following dosage strengths to be taken twice daily (with or without food): 6.25mg, 12.5mg, 25mg, 50mg, and 100mg. |
| metoprolol succinate | ACTIVE_COMPARATOR | metoprolol succinate (Toprol-XL) Participants were randomized (1:1) to blinded treatment with bucindolol or metoprolol and titrated weekly to target doses of 50 mg twice daily (BID; \< 75 kg) or 100 mg BID (≥ 75 kg) for bucindolol or 200 mg once daily (QD) for metoprolol. 84% of bucindolol participants attained target dose and 72% of metoprolol participants attained target dose. The lowest starting dose of metoprolol was 25 mg QD with weekly dose titrations to the target dose or to the maximum tolerated dose. The starting dose assigned was based upon the patient's beta-blocker treatment prior to randomization. Capsules for titration were available in the following dosage strengths to be taken twice daily (with or without food): 25mg, 50mg, 100mg, 200mg and/or matching placebo oral capsule to maintain blinded dosing. |
| Name | Type | Description |
|---|---|---|
| bucindolol hydrochloride | DRUG | - |
| metoprolol succinate | DRUG | - |
| Placebo oral capsule | OTHER | - |
Key Inclusion Criteria: * Must weigh at least 40 kg * Possess the β1389 Arg/Arg genotype * Left Ventricular Ejection Fraction (LVEF) \< 0.50 assessed within 12 months prior to Screening * At least one episode of symptomatic paroxysmal or persistent AF within 180 days of Screening * Clinically appro...
Bucindolol is an investigational small molecule being studied for the treatment of current or recent history of atrial fibrillation. It is being developed as a cardiovascular therapy, with a completed Phase 2 clinical trial evaluating its use in patients with this condition.
Bucindolol is a small molecule cardiovascular drug. Its specific molecular target has not been disclosed in the available information. The drug is being investigated for its potential role in managing atrial fibrillation, though its precise mechanism of action is not specified.
Bucindolol is being developed by Medtronic plc, a medical technology company traded on the NYSE under the ticker symbol MDT. The company is conducting clinical research on this drug for the treatment of atrial fibrillation.
Bucindolol is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. A Phase 2 trial has been completed, and the drug remains under investigation for its potential use in atrial fibrillation.
Bucindolol has one completed clinical trial registered under NCT01970501, titled "Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure." This Phase 2 study enrolled 267 participants across the United States, Canada, Hungary, Netherlands, Poland, and Serbia.
Bucindolol is a distinct investigational drug with no alternative names provided in the available information. It is being studied specifically for its potential role in treating atrial fibrillation and is not known to be marketed under any other name.