NCT00565565

Brief Summary

This study is to demonstrate the safety and tolerability of a single oral dose of BAY60-4552 in a single dose escalation design. Furthermore, this study examines the changes in hemodynamics after application of the test substance.42 hospitalized stable patients with chronic heart failure will be included. Several measurements will be performed to test how good the drug works and wether there are any unwanted reactions to the drug (e.g. blood tests, ECG, heart rate, blood pressure, adverse events). After a observation period the patient will be discharged from the hospital.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P75+ for phase_1 heart-failure

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2007

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 30, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

October 31, 2007

Last Update Submit

August 9, 2016

Conditions

Heart Failure

Keywords

Biventriular chronic heart failure, Pulmonary hypertension

Outcome Measures

Primary Outcomes (7)

  • 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

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

    Pre-dose and up to 72 hr post-dose

  • AUC/D

    AUC divided by dose (mg)

    Pre-dose and up to 72 hr post-dose

  • Cmax

    Maximum drug concentration in plasma after single dose administration

    Pre-dose and up to 72 hr post-dose

  • Cmax/D

    Cmax divided by dose (mg)

    Pre-dose and up to 72 hr post-dose

  • Number of participants with adverse events

    Approximately 2 weeks

Secondary Outcomes (35)

  • 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

  • Heart rate

    At pre-study visit, pre-dose and up to 24 hr post-dose

  • Cardiac output

    Pre-dose and up to 6 hr post-dose

  • +30 more secondary outcomes

Study Arms (5)

BAY60-4552, 1 mg

EXPERIMENTAL

Subjects were planned to receive 1 mg of BAY60-4552 as solution

Drug: BAY60-4552

BAY60-4552, 2.5 mg

EXPERIMENTAL

Subjects were planned to receive 2.5 mg of BAY60-4552 as tablet

Drug: BAY60-4552

BAY60-4552, 5 mg

EXPERIMENTAL

Subjects were planned to receive 5.0 mg of BAY60-4552 as tablet

Drug: BAY60-4552

BAY60-4552, 7.5 mg

EXPERIMENTAL

Subjects were planned to receive 7.5 mg of BAY60-4552 as tablet

Drug: BAY60-4552

BAY60-4552, 10 mg

EXPERIMENTAL

Subjects were planned to receive 10 mg of BAY60-4552 as tablet

Drug: BAY60-4552

Interventions

BAY60-4552DRUG

Single dose escalation planned at dose of 1 mg, 2.5 mg, 5 mg, 7.5 mg, and 10 mg

BAY60-4552, 1 mgBAY60-4552, 10 mgBAY60-4552, 2.5 mgBAY60-4552, 5 mgBAY60-4552, 7.5 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic heart failure, undergoing routine invasive measurement of hemodynamic parameters

You may not qualify if:

  • Acute heart failure or acute decompensated heart failure, need for acute cardiologic intervention or surgery, severe renal or hepatic insufficiency, severe valvular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Bad Nauheim, Hesse, 61231, Germany

Location

Unknown Facility

Giessen, Hesse, 35392, Germany

Location

Related Publications (1)

  • Acute hemodynamic response to single oral doses of BAY 60-4552, a soluble guanylate cyclase stimulator, in patients with biventricular heart failure. V Mitrovic, B Swidnicki, A Ghofrani, W Mück, N Kirschbaum, J Mittendorf, J-P Stasch, G Wensing, R Frey, S Lentini. BMC Pharmacology 2009; 9(Suppl 1): P51.

    RESULT

Related Links

MeSH Terms

Conditions

Heart FailureHypertension, Pulmonary

Interventions

BAY 60-4552

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesHypertensionVascular Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2007

First Posted

November 30, 2007

Study Start

October 1, 2007

Primary Completion

December 1, 2008

Study Completion

April 1, 2009

Last Updated

August 10, 2016

Record last verified: 2016-08

Locations

DE(2)