Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as First Test Concor (Fed), First Reference Concor (Fed)
Bisoprolol · 1 trial · 1 indication
Baseline was defined as the latest SBP under monotherapy.
| Arm | Type | Description |
|---|---|---|
| Bisoprolol failed group | EXPERIMENTAL | Subjects who failed monotherapy with bisoprolol 5 milligram (mg) before trial inclusion will be randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet |
| Amlodipine failed group | EXPERIMENTAL | Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion will be randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. |
| Name | Type | Description |
|---|---|---|
| Bisoprolol/Amlodipine (Bisoprolol failed group) | DRUG | Bisoprolol/Amlodipine FDC tablet will be orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If blood pressure (BP) is controlled at Week 6 (Day 43), the same dose will continue for next 6 weeks. If the BP is not controlled at Day 43, the dose will be increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks. Subjects who have controlled BP at Week 12 (Day 85), will continue with the same dose for next 6 weeks. If their BP is not controlled at Day 85, dose will be increased to the next level (Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine and 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127). |
| Bisoprolol/Amlodipine (Amlodipine failed group) | DRUG | Bisoprolol/Amlodipine FDC tablet will be orally administered at an initial dose of 5 milligram (mg)/5 mg once daily for 6 weeks. If BP is controlled at Week 6 (Day 43), the same dose will continue for next 6 weeks. If the BP is not controlled at Day 43, the dose will be increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks. Subjects who have controlled BP at Week 12 (Day 85), will continue with the same dose for next 6 weeks. If their BP is not controlled at Day 85, dose will be increased to the next level (Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine and 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127). |
Inclusion Criteria: * Essential hypertension not controlled at 5 mg bisoprolol or 5 mg amlodipine at least 4 weeks (definition of not controlled: SBP greater than or equal to (\>=) 140 millimeter of mercury (mmHg) with or without DBP \>= 90 mmHg) * Male or female subjects \>=18 years of age, withou...
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Bisoprolol is being developed for the treatment of hypertension, or high blood pressure. It has been studied as part of a fixed dose combination with amlodipine in a Phase 3 trial in Germany. The program targets adults with hypertension.
Bisoprolol targets ADRB1, the beta-1 adrenergic receptor. It acts as an antagonist at this receptor, which is the mechanism underlying its use in cardiovascular conditions such as hypertension.
Bisoprolol is being developed by Merck KGaA, which trades under the ticker MKGAF. The company is evaluating the drug as part of a fixed dose combination with amlodipine for hypertension.
Bisoprolol is in Phase 3 development for hypertension. The Phase 3 trial has been completed, and no active trials are currently listed. It is an investigational product and has not been approved for this use.
Bisoprolol has been studied in one completed Phase 3 trial, NCT01977794, titled Fixed Dose Combination of Bisoprolol and Amlodipine in the Treatment of Hypertension. The trial enrolled 200 adults in Germany and was randomized and controlled.