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/Amlodipine is a fixed dose combination small molecule therapy being developed by Merck KGaA for the treatment of hypertension. It pairs bisoprolol with amlodipine in a single formulation. The combination has been studied in a Phase 3 trial in Germany.
Bisoprolol/Amlodipine is used for the treatment of hypertension, also known as high blood pressure. It is a fixed dose combination product developed by Merck KGaA. The Phase 3 trial NCT01977794 evaluated it in adults with hypertension.
Bisoprolol/Amlodipine targets ADRB1, the beta-1 adrenergic receptor, as an antagonist. Bisoprolol is the component that acts on this receptor. The combination is a small molecule product developed by Merck KGaA for hypertension.
Bisoprolol/Amlodipine is developed by Merck KGaA, which trades under the ticker MKGAF. The company ran the Phase 3 trial of the fixed dose combination in hypertension.
Bisoprolol/Amlodipine is in Phase 3 development. One Phase 3 trial, NCT01977794, has been completed. The drug is investigational and is not approved for marketing based on the available information.
Bisoprolol/Amlodipine has been studied in one Phase 3 trial, NCT01977794, titled Fixed Dose Combination of Bisoprolol and Amlodipine in the Treatment of Hypertension. The trial was completed, enrolled 200 participants, was randomized and controlled, and was conducted in Germany.
Bisoprolol/Amlodipine is a fixed dose combination product, while bisoprolol is one of its two active components. The combination also includes amlodipine. The trial NCT01977794 included a bisoprolol failed group as part of its design.