Single Dose Escalation Study in Patients With Chronic Heart Failure

NCT ID: NCT00565565

Last Updated: 2016-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BAY60-4552, 1 mg

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

Group Type EXPERIMENTAL

BAY60-4552

Intervention Type DRUG

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

BAY60-4552, 2.5 mg

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

Group Type EXPERIMENTAL

BAY60-4552

Intervention Type DRUG

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

BAY60-4552, 5 mg

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

Group Type EXPERIMENTAL

BAY60-4552

Intervention Type DRUG

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

BAY60-4552, 7.5 mg

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

Group Type EXPERIMENTAL

BAY60-4552

Intervention Type DRUG

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

BAY60-4552, 10 mg

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

Group Type EXPERIMENTAL

BAY60-4552

Intervention Type DRUG

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

Interventions

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BAY60-4552

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

Intervention Type DRUG

Eligibility Criteria

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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, severe valvular disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Bad Nauheim, Hesse, Germany

Site Status

Giessen, Hesse, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT

Related Links

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http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Other Identifiers

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2007-003216-54

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12356

Identifier Type: -

Identifier Source: org_study_id

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