check_circleStudy Completed

Heart Failure

Bayer Identifier:

12356

ClinicalTrials.gov Identifier:

NCT00565565

EudraCT Number:

2007-003216-54

EU CT Number:

Not Available
Single dose escalation study in patients with chronic heart failure

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Patients with chronic heart failure, undergoing routine invasive measurement of hemodynamic parameters
  • - Acute heart failure or acute decompensated heart failure, need for acute cardiologic intervention or surgery, severe renal or hepatic insufficiency, severe valvular disease

Trial summary

Enrollment Goal
55
Trial Dates
October 2007 - April 2009
Phase
Phase 1
Could I Receive a placebo
No
Products
Nelociguat (BAY60-4552)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Gießen, 35392, Germany
Completed
Bad Nauheim, 61231, Germany

Primary Outcome

  • Change in pulmonary capillary wedge pressure
    date_rangeTime Frame:
    Pre-dose and up to 6 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Change in mean pulmonary artery pressure
    date_rangeTime Frame:
    Pre-dose and up to 6 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUC
    Area under the plasma concentration vs time curve from zero to infinity after single dose
    date_rangeTime Frame:
    Pre-dose and up to 72 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUC/D
    AUC divided by dose (mg)
    date_rangeTime Frame:
    Pre-dose and up to 72 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cmax
    Maximum drug concentration in plasma after single dose administration
    date_rangeTime Frame:
    Pre-dose and up to 72 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cmax/D
    Cmax divided by dose (mg)
    date_rangeTime Frame:
    Pre-dose and up to 72 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events
    date_rangeTime Frame:
    Approximately 2 weeks
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    Safety Issue:
    Yes

Secondary Outcome

  • Mean right atrial pressure
    date_rangeTime Frame:
    Pre-dose and up to 6 hr post-dose
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    Safety Issue:
    No
  • Systolic pulmonary artery pressure
    date_rangeTime Frame:
    Pre-dose and up to 6 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Diastolic pulmonary artery pressure
    date_rangeTime Frame:
    Pre-dose and up to 6 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Heart rate
    date_rangeTime Frame:
    At pre-study visit, pre-dose and up to 24 hr post-dose
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    Safety Issue:
    Yes
  • Cardiac output
    date_rangeTime Frame:
    Pre-dose and up to 6 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Pulmonary vascular resistance
    date_rangeTime Frame:
    Pre-dose and up to 6 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Pulmonary vascular resistance index
    date_rangeTime Frame:
    Pre-dose and up to 6 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Systemic vascular resistance
    date_rangeTime Frame:
    Pre-dose and up to 6 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Systemic vascular resistance index
    date_rangeTime Frame:
    Pre-dose and up to 6 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cardiac index
    date_rangeTime Frame:
    Pre-dose and up to 6 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Mean arterial pressure
    date_rangeTime Frame:
    Pre-dose and up to 6 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Systemic blood pressure
    date_rangeTime Frame:
    At pre-study visit, pre-dose and up to 24 hr post-dose
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    Safety Issue:
    Yes
  • Diastolic blood pressure
    date_rangeTime Frame:
    At pre-study visit, pre-dose and up to 24 hr post-dose
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    Safety Issue:
    Yes
  • Dyspnea Score
    Subject is asked unpersuasively about his/her well-being in comparison to the baseline condition, measured on a 7-point Likert scale.
    date_rangeTime Frame:
    Pre-dose and up to 48 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-6)
    AUC from time 0 to 6 h after study drug intake
    date_rangeTime Frame:
    Pre-dose and up to 6 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUCnorm
    AUC divided by dose (mg) per kg body weight
    date_rangeTime Frame:
    Pre-dose and up to 72 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tn)
    AUC from time 0 to the last data point
    date_rangeTime Frame:
    Pre-dose and up to 72 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tn)norm
    AUC(0-tn) divided by dose (mg) per kg body weight
    date_rangeTime Frame:
    Pre-dose and up to 72 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cmax,norm
    Cmax divided by dose (mg) per kg body weight
    date_rangeTime Frame:
    Pre-dose and up to 72 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • tmax
    Time to reach maximum drug concentration in plasma after single dose
    date_rangeTime Frame:
    Pre-dose and up to 72 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • t½
    Half-life associated with the terminal slope
    date_rangeTime Frame:
    Pre-dose and up to 72 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Mean residence time
    date_rangeTime Frame:
    Pre-dose and up to 72 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance)
    date_rangeTime Frame:
    Pre-dose and up to 72 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Apparent volume of distribution associated with the terminal phase (after oral administration)
    date_rangeTime Frame:
    Pre-dose and up to 72 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Amount of drug excreted via urine
    date_rangeTime Frame:
    Pre-dose and up to 6 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Percent amount of drug excreted via urine
    date_rangeTime Frame:
    Pre-dose and up to 6 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Renal clearance of drug
    date_rangeTime Frame:
    Pre-dose and up to 6 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Renin activity
    date_rangeTime Frame:
    Pre-dose and up to 24 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline of noradrenaline after drug administration
    date_rangeTime Frame:
    Pre-dose and up to 24 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • N-terminal pro-atrial natriuretic peptide
    date_rangeTime Frame:
    Pre-dose and up to 24 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • NT-pro B-type natriuretic peptide
    date_rangeTime Frame:
    Pre-dose and up to 24 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Big endothelin-1
    date_rangeTime Frame:
    Pre-dose and up to 24 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cystatin C
    date_rangeTime Frame:
    Pre-dose and up to 24 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline of osteopontin after drug administration
    date_rangeTime Frame:
    Pre-dose and up to 24 hr post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Cyclic guanosine mono-phosphate
    date_rangeTime Frame:
    Pre-dose and up to 24 hr post-dose
    enhanced_encryption
    Safety Issue:
    No

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
5

Additional Information

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