Recent Updates
Recently added Catalysts

BAY60-4552

Phase 1

Heart Failure | Small molecule | Cardiovascular |Bayer AG|Last Updated: Aug 10, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment55

FDA Designations

No designations recorded

Clinical trial landscape

BAY60-4552 · 1 trial · 1 indication

Phase 1 1
NCT00565565Single Dose Escalation Study in Patients With Chronic Heart FailureHeart Failure
COMPLETED55 Analytics
PHASE1COMPLETED
Single Dose Escalation Study in Patients With Chronic Heart Failure
Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in pulmonary capillary wedge pressure
Pre-dose and up to 6 hr post-dose
Change in mean pulmonary artery pressure
Pre-dose and up to 6 hr post-dose
AUC
Pre-dose and up to 72 hr post-dose

Area under the plasma concentration vs time curve from zero to infinity after single dose

AUC/D
Pre-dose and up to 72 hr post-dose

AUC divided by dose (mg)

Cmax
Pre-dose and up to 72 hr post-dose

Maximum drug concentration in plasma after single dose administration

Cmax/D
Pre-dose and up to 72 hr post-dose

Cmax divided by dose (mg)

Number of participants with adverse events
Approximately 2 weeks

Secondary Endpoints

Mean right atrial pressure
Pre-dose and up to 6 hr post-dose
Systolic pulmonary artery pressure
Pre-dose and up to 6 hr post-dose
Diastolic pulmonary artery pressure
Pre-dose and up to 6 hr post-dose
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BAY60-4552, 1 mgEXPERIMENTALSubjects were planned to receive 1 mg of BAY60-4552 as solution
BAY60-4552, 2.5 mgEXPERIMENTALSubjects were planned to receive 2.5 mg of BAY60-4552 as tablet
BAY60-4552, 5 mgEXPERIMENTALSubjects were planned to receive 5.0 mg of BAY60-4552 as tablet
BAY60-4552, 7.5 mgEXPERIMENTALSubjects were planned to receive 7.5 mg of BAY60-4552 as tablet
BAY60-4552, 10 mgEXPERIMENTALSubjects were planned to receive 10 mg of BAY60-4552 as tablet

Interventions

NameTypeDescription
BAY60-4552DRUGSingle dose escalation planned at dose of 1 mg, 2.5 mg, 5 mg, 7.5 mg, and 10 mg
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Patients with chronic heart failure, undergoing routine invasive measurement of hemodynamic parameters Exclusion Criteria: * Acute heart failure or acute decompensated heart failure, need for acute cardiologic intervention or surgery, severe renal or hepatic insufficiency, s...

Countries:Germany
Unlock Eligibility Criteria

Frequently asked questions about BAY60-4552

What is BAY60-4552 used for?

BAY60-4552 is an investigational small molecule being developed for heart failure and erectile dysfunction. It is being studied in patients with chronic heart failure and in men with erectile dysfunction, including those not sufficiently responsive to standard PDE5 inhibitor therapy. The drug is in clinical development and is not approved.

Who makes BAY60-4552?

BAY60-4552 is being developed by Bayer AG, a German pharmaceutical company. Bayer AG trades on the OTC market under the ticker BAYRY. The company is conducting clinical trials of BAY60-4552 in cardiovascular and erectile dysfunction indications.

What phase is BAY60-4552 in?

BAY60-4552 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and one Phase 2 proof-of-concept study has also been completed. The drug remains investigational and has not received regulatory approval.

What clinical trials is BAY60-4552 in?

BAY60-4552 has been studied in three completed clinical trials. NCT00565565 was a single-dose escalation study in chronic heart failure patients. NCT01110590 was a multiple-dose study of vardenafil and BAY60-4552 in erectile dysfunction. NCT01168817 was a Phase 2 proof-of-concept study combining BAY60-4552 with vardenafil for erectile dysfunction.

How does BAY60-4552 work?

BAY60-4552 is a small molecule being studied for its effects in cardiovascular and erectile dysfunction conditions. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being evaluated in combination with vardenafil, a PDE5 inhibitor, for erectile dysfunction.

Is BAY60-4552 the same as vardenafil?

No, BAY60-4552 is not the same as vardenafil. BAY60-4552 is a separate investigational drug being studied alone and in combination with vardenafil. Clinical trials have evaluated BAY60-4552 both as a single agent and in combination with vardenafil for erectile dysfunction.