Skip to main content
OpenTrials
Completed

NCT Number: NCT00565565

Single Dose Escalation Study in Patients With Chronic Heart Failure

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bad Nauheim, Hesse, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAY60-4552

Drug

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

Primary outcomes

  1. Change in pulmonary capillary wedge pressure

    Time frame: Pre-dose and up to 6 hr post-dose

  2. Change in mean pulmonary artery pressure

    Time frame: Pre-dose and up to 6 hr post-dose

  3. AUC

    Time frame: Pre-dose and up to 72 hr post-dose

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

  4. AUC/D

    Time frame: Pre-dose and up to 72 hr post-dose

    AUC divided by dose (mg)

  5. Cmax

    Time frame: Pre-dose and up to 72 hr post-dose

    Maximum drug concentration in plasma after single dose administration

  6. Cmax/D

    Time frame: Pre-dose and up to 72 hr post-dose

    Cmax divided by dose (mg)

  7. Number of participants with adverse events

    Time frame: Approximately 2 weeks

Secondary outcomes

  1. Mean right atrial pressure

    Time frame: Pre-dose and up to 6 hr post-dose

  2. Systolic pulmonary artery pressure

    Time frame: Pre-dose and up to 6 hr post-dose

  3. Diastolic pulmonary artery pressure

    Time frame: Pre-dose and up to 6 hr post-dose

  4. Heart rate

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

  5. Cardiac output

    Time frame: Pre-dose and up to 6 hr post-dose

  6. Pulmonary vascular resistance

    Time frame: Pre-dose and up to 6 hr post-dose

  7. Pulmonary vascular resistance index

    Time frame: Pre-dose and up to 6 hr post-dose

  8. Systemic vascular resistance

    Time frame: Pre-dose and up to 6 hr post-dose

  9. Systemic vascular resistance index

    Time frame: Pre-dose and up to 6 hr post-dose

  10. Cardiac index

    Time frame: Pre-dose and up to 6 hr post-dose

  11. Mean arterial pressure

    Time frame: Pre-dose and up to 6 hr post-dose

  12. Systemic blood pressure

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

  13. Diastolic blood pressure

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

  14. Dyspnea Score

    Time frame: Pre-dose and up to 48 hr post-dose

    Subject is asked unpersuasively about his/her well-being in comparison to the baseline condition, measured on a 7-point Likert scale.

  15. AUC(0-6)

    Time frame: Pre-dose and up to 6 hr post-dose

    AUC from time 0 to 6 h after study drug intake

  16. AUCnorm

    Time frame: Pre-dose and up to 72 hr post-dose

    AUC divided by dose (mg) per kg body weight

  17. AUC(0-tn)

    Time frame: Pre-dose and up to 72 hr post-dose

    AUC from time 0 to the last data point

  18. AUC(0-tn)norm

    Time frame: Pre-dose and up to 72 hr post-dose

    AUC(0-tn) divided by dose (mg) per kg body weight

  19. Cmax,norm

    Time frame: Pre-dose and up to 72 hr post-dose

    Cmax divided by dose (mg) per kg body weight

  20. tmax

    Time frame: Pre-dose and up to 72 hr post-dose

    Time to reach maximum drug concentration in plasma after single dose

  21. t½

    Time frame: Pre-dose and up to 72 hr post-dose

    Half-life associated with the terminal slope

  22. Mean residence time

    Time frame: Pre-dose and up to 72 hr post-dose

  23. Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance)

    Time frame: Pre-dose and up to 72 hr post-dose

  24. Apparent volume of distribution associated with the terminal phase (after oral administration)

    Time frame: Pre-dose and up to 72 hr post-dose

  25. Amount of drug excreted via urine

    Time frame: Pre-dose and up to 6 hr post-dose

  26. Percent amount of drug excreted via urine

    Time frame: Pre-dose and up to 6 hr post-dose

  27. Renal clearance of drug

    Time frame: Pre-dose and up to 6 hr post-dose

  28. Renin activity

    Time frame: Pre-dose and up to 24 hr post-dose

  29. Change from baseline of noradrenaline after drug administration

    Time frame: Pre-dose and up to 24 hr post-dose

  30. N-terminal pro-atrial natriuretic peptide

    Time frame: Pre-dose and up to 24 hr post-dose

  31. NT-pro B-type natriuretic peptide

    Time frame: Pre-dose and up to 24 hr post-dose

  32. Big endothelin-1

    Time frame: Pre-dose and up to 24 hr post-dose

  33. Cystatin C

    Time frame: Pre-dose and up to 24 hr post-dose

  34. Change from baseline of osteopontin after drug administration

    Time frame: Pre-dose and up to 24 hr post-dose

  35. Cyclic guanosine mono-phosphate

    Time frame: Pre-dose and up to 24 hr post-dose

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Proof of Concept Study to Investigate Safety, Tolerability, Pharmacokinetics and the Impact on Pulmonary and Systemic Hemodynamics of a Single Oral Dose of BAY60-4552 in Patients With Biventricular Chronic Heart Failure and Pulmonary Hypertension in a Non-randomized, Non-blinded, Dose Escalation Design.

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Nov 30, 2007
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.