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Multiple Dose Study in Heart Failure of BAY 1067197

NCT02040233 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-06-21

No results posted yet for this study

Summary

This is a study to investigate the safety, tolerability and early effects on cardiac function of the partial A1 agonist BAY1067197 in patients with chronic heart failure. BAY1067197 will be applied once daily over 7 days in addition to standard therapy including a beta-blocker. The aim of the study is to assess if a 7 day treatment with BAY1067197 is well tolerated when given on top of standard therapy for heart failure. Furthermore, the study aims to assess if cardiac function improves in the early course of therapy.

Conditions

Interventions

DRUG

BAY1067197 (10 mg)

10 mg BAY1067197 for 7 d treatment once daily as oral application

DRUG

BAY1067197

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.

DRUG

Placebo (10 mg)

10 mg Placebo for 7 d treatment once daily as oral application

DRUG

Placebo

5 mg / or 10 mg / or 20 mg Placebo for 7 d treatment once daily as oral application

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-28
Primary Completion
2015-01-29
Completion
2015-04-02

Countries

  • Germany
  • Italy
  • Netherlands
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02040233 on ClinicalTrials.gov