Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bisoprolol/Amlodipine · 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...
Bisoprolol/Amlodipine is a fixed-dose combination of two small molecule drugs being developed for the treatment of hypertension. It is currently in Phase 3 clinical development and is intended to lower blood pressure in patients with this condition.
Bisoprolol/Amlodipine combines bisoprolol, a beta-blocker, and amlodipine, a calcium channel blocker. These two mechanisms work together to reduce blood pressure by slowing the heart rate and relaxing blood vessels, respectively.
Bisoprolol/Amlodipine is being developed by Merck KGaA, a German pharmaceutical company. The company's stock is traded over-the-counter under the ticker MKGAF.
Bisoprolol/Amlodipine is in Phase 3 clinical development for hypertension. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 3 trial has been completed.
Bisoprolol/Amlodipine has one completed Phase 3 trial, NCT01977794, titled "Fixed Dose Combination of Bisoprolol and Amlodipine in the Treatment of Hypertension." This trial enrolled 200 participants in Germany and was a controlled, randomized study.
Bisoprolol/Amlodipine is a fixed-dose combination product that contains both bisoprolol and amlodipine in a single tablet. It is distinct from taking either medication alone, as it combines both active ingredients to treat hypertension.