Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY1067197 · 2 trials · 1 indication
Heart rate was measured by monitor measurements after 30 minutes resting in a supine position. The relevant changes in heart rate were recorded and analysed.
Blood pressure was measured by monitor measurements after 30 minutes resting in a supine position. The relevant changes in blood pressure were recorded and analysed.
A complete standard 12-lead ECG was recorded and evaluated parameters such as heart rate, PR/PQinterval, QRSD interval, QT interval (uncorrected). Clinically relevant findings in ECG such as a second degree AV-block Mobitz type I (Wenkebach), Mobitz type II - or any third-degree AV block were recorded and reported. A 24-hour Holter ECG was recorded with a standard Holter ECG recorder for the purpose of detecting AV blocks, no higher degree AV blocks \> 1 or clinically relevant effect on HR were observed during Holter monitoring periods.
The change in LVEF between the post and the pre-treatment measurements were analyzed using Bayesian statistics to quantify the difference between BAY1067197 treatment and placebo measured by CMR. LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart.
Maximum observed BAY84-3174 concentration in plasma, directly taken from analytical data. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Maximum observed drug concentration, directly taken from analytical data, divided by dose. Geometric mean and %CV were reported.
AUCtau is defined as area under the plasma concentration time profile from time zero to the end of the dosing interval after the first dose and dosing interval was 24 h for both arms. Geometric mean and %CV were reported.
AUCtau/D is defined as area under the plasma concentration time profile from time zero to the end of the dosing interval divided by dose after the first dose and dosing interval was 24 h for both arms. Geometric mean and %CV were reported.
Cmax,md is defined as maximum observed drug concentration in plasma after multiple-dose administrations during a dosing interval directly taken from analytical data.Geometric mean and %CV were reported.
Maximum observed drug concentration, directly taken from analytical data divided by dose after multiple doses. Geometric mean and %CV were reported.
AUCtau,md is defined as area under the plasma concentration time profile from time zero during the dosing interval after multiple-dose administrations and dosing interval was 24 h for both arms. Geometric mean and %CV were reported.
AUCtau,md/D is defined as area under the plasma concentration time profile from time zero to the end of the dosing interval after multiple dose of administrations divided by dose and dosing interval was 24 h for both arms. Geometric mean and %CV were reported.
| Arm | Type | Description |
|---|---|---|
| BAY1067197 (10 mg) | ACTIVE_COMPARATOR | - |
| BAY1067197 | ACTIVE_COMPARATOR | - |
| Placebo (10 mg) | PLACEBO_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Placebo and BAY1067197 | EXPERIMENTAL | Patients will get both treatment 1 and 2 |
| Name | Type | Description |
|---|---|---|
| BAY1067197 (10 mg) | DRUG | 10 mg BAY1067197 for 7 d treatment once daily as oral application |
| BAY1067197 | DRUG | The dose escalation to the second dose step will proceed only if the previous dose step has shown acceptable safety and tolerability 5 mg / or 10 mg / or 20 mg BAY1067197 for 7 d treatment as oral application. |
| Placebo (10 mg) | DRUG | 10 mg Placebo for 7 d treatment once daily as oral application |
| Placebo | DRUG | 5 mg / or 10 mg / or 20 mg Placebo for 7 d treatment once daily as oral application |
| Placebo (treatment 1) | DRUG | Oral administration of placebo tablets |
| BAY1067197 (treatment 2) | DRUG | Oral administration of a single dose of 30 mg (3×10 mg Tablet) BAY1067197 |
* Inclusion Criteria: * Clinical diagnosis of chronic systolic heart failure of ischemic or non-ischemic etiology:(New York Heart Association)NYHA class I-III and treatment with standard pharmacological therapy for the treatment of systolic heart failure including β-blocker ≥ 4 weeks prior to random...
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BAY1067197 is an investigational small molecule being developed for heart failure. It is being studied in patients with stable heart failure who are on standard therapy including a beta-blocker. The drug is in Phase 2 clinical development and is not yet approved by regulatory authorities.
BAY1067197 is being developed by Bayer AG, a German pharmaceutical company. Bayer's stock is traded on the OTC market under the ticker symbol BAYRY. The company is conducting clinical trials to evaluate the safety and efficacy of this drug in heart failure patients.
BAY1067197 is in Phase 2 clinical development. Two Phase 2 trials have been completed, both in heart failure patients. The drug is still investigational and has not received regulatory approval. It is being studied for its safety and potential therapeutic effects in this patient population.
BAY1067197 has completed two Phase 2 clinical trials. NCT01945606 assessed safety in stable heart failure patients on standard therapy including a beta-blocker, enrolling 11 participants in the Netherlands. NCT02040233 was a multiple dose study in heart failure, enrolling 31 participants across Germany, Italy, Netherlands, and Poland.
Yes, BAY1067197 and BAY 1067197 refer to the same drug. The compound is identified by the same name in both clinical trial registrations, with the spacing in the name varying. Both trials listed under these names are Phase 2 studies in heart failure patients.