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Single Dose Escalation Study in Patients With Chronic Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00565565
First received: October 31, 2007
Last updated: August 9, 2016
Last verified: August 2016

October 31, 2007
August 9, 2016
October 2007
December 2008   (final data collection date for primary outcome measure)
  • Change in pulmonary capillary wedge pressure [ Time Frame: Pre-dose and up to 6 hr post-dose ] [ Designated as safety issue: No ]
  • Change in mean pulmonary artery pressure [ Time Frame: Pre-dose and up to 6 hr post-dose ] [ Designated as safety issue: No ]
  • AUC [ Time Frame: Pre-dose and up to 72 hr post-dose ] [ Designated as safety issue: No ]
    Area under the plasma concentration vs time curve from zero to infinity after single dose
  • AUC/D [ Time Frame: Pre-dose and up to 72 hr post-dose ] [ Designated as safety issue: No ]
    AUC divided by dose (mg)
  • Cmax [ Time Frame: Pre-dose and up to 72 hr post-dose ] [ Designated as safety issue: No ]
    Maximum drug concentration in plasma after single dose administration
  • Cmax/D [ Time Frame: Pre-dose and up to 72 hr post-dose ] [ Designated as safety issue: No ]
    Cmax divided by dose (mg)
  • Number of participants with adverse events [ Time Frame: Approximately 2 weeks ] [ Designated as safety issue: Yes ]
The study is to investigate the safety, tolerability, pharmacokinetics and the impact on pulmonary and systemic hemodynamics of single doses of orally administered BAY 60-4552 in a single dose escalation design. [ Time Frame: 72 hours ]
Complete list of historical versions of study NCT00565565 on ClinicalTrials.gov Archive Site
  • Mean right atrial pressure [ Time Frame: Pre-dose and up to 6 hr post-dose ] [ Designated as safety issue: No ]
  • Systolic pulmonary artery pressure [ Time Frame: Pre-dose and up to 6 hr post-dose ] [ Designated as safety issue: No ]
  • Diastolic pulmonary artery pressure [ Time Frame: Pre-dose and up to 6 hr post-dose ] [ Designated as safety issue: No ]
  • Heart rate [ Time Frame: At pre-study visit, pre-dose and up to 24 hr post-dose ] [ Designated as safety issue: Yes ]
  • Cardiac output [ Time Frame: Pre-dose and up to 6 hr post-dose ] [ Designated as safety issue: No ]
  • Pulmonary vascular resistance [ Time Frame: Pre-dose and up to 6 hr post-dose ] [ Designated as safety issue: No ]
  • Pulmonary vascular resistance index [ Time Frame: Pre-dose and up to 6 hr post-dose ] [ Designated as safety issue: No ]
  • Systemic vascular resistance [ Time Frame: Pre-dose and up to 6 hr post-dose ] [ Designated as safety issue: No ]
  • Systemic vascular resistance index [ Time Frame: Pre-dose and up to 6 hr post-dose ] [ Designated as safety issue: No ]
  • Cardiac index [ Time Frame: Pre-dose and up to 6 hr post-dose ] [ Designated as safety issue: No ]
  • Mean arterial pressure [ Time Frame: Pre-dose and up to 6 hr post-dose ] [ Designated as safety issue: No ]
  • Systemic blood pressure [ Time Frame: At pre-study visit, pre-dose and up to 24 hr post-dose ] [ Designated as safety issue: Yes ]
  • Diastolic blood pressure [ Time Frame: At pre-study visit, pre-dose and up to 24 hr post-dose ] [ Designated as safety issue: Yes ]
  • Dyspnea Score [ Time Frame: Pre-dose and up to 48 hr post-dose ] [ Designated as safety issue: No ]
    Subject is asked unpersuasively about his/her well-being in comparison to the baseline condition, measured on a 7-point Likert scale.
  • AUC(0-6) [ Time Frame: Pre-dose and up to 6 hr post-dose ] [ Designated as safety issue: No ]
    AUC from time 0 to 6 h after study drug intake
  • AUCnorm [ Time Frame: Pre-dose and up to 72 hr post-dose ] [ Designated as safety issue: No ]
    AUC divided by dose (mg) per kg body weight
  • AUC(0-tn) [ Time Frame: Pre-dose and up to 72 hr post-dose ] [ Designated as safety issue: No ]
    AUC from time 0 to the last data point
  • AUC(0-tn)norm [ Time Frame: Pre-dose and up to 72 hr post-dose ] [ Designated as safety issue: No ]
    AUC(0-tn) divided by dose (mg) per kg body weight
  • Cmax,norm [ Time Frame: Pre-dose and up to 72 hr post-dose ] [ Designated as safety issue: No ]
    Cmax divided by dose (mg) per kg body weight
  • tmax [ Time Frame: Pre-dose and up to 72 hr post-dose ] [ Designated as safety issue: No ]
    Time to reach maximum drug concentration in plasma after single dose
  • t½ [ Time Frame: Pre-dose and up to 72 hr post-dose ] [ Designated as safety issue: No ]
    Half-life associated with the terminal slope
  • Mean residence time [ Time Frame: Pre-dose and up to 72 hr post-dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Apparent volume of distribution associated with the terminal phase (after oral administration) [ Time Frame: Pre-dose and up to 72 hr post-dose ] [ Designated as safety issue: No ]
  • Amount of drug excreted via urine [ Time Frame: Pre-dose and up to 6 hr post-dose ] [ Designated as safety issue: No ]
  • Percent amount of drug excreted via urine [ Time Frame: Pre-dose and up to 6 hr post-dose ] [ Designated as safety issue: No ]
  • Renal clearance of drug [ Time Frame: Pre-dose and up to 6 hr post-dose ] [ Designated as safety issue: No ]
  • Renin activity [ Time Frame: Pre-dose and up to 24 hr post-dose ] [ Designated as safety issue: No ]
  • Change from baseline of noradrenaline after drug administration [ Time Frame: Pre-dose and up to 24 hr post-dose ] [ Designated as safety issue: No ]
  • N-terminal pro-atrial natriuretic peptide [ Time Frame: Pre-dose and up to 24 hr post-dose ] [ Designated as safety issue: No ]
  • NT-pro B-type natriuretic peptide [ Time Frame: Pre-dose and up to 24 hr post-dose ] [ Designated as safety issue: No ]
  • Big endothelin-1 [ Time Frame: Pre-dose and up to 24 hr post-dose ] [ Designated as safety issue: No ]
  • Cystatin C [ Time Frame: Pre-dose and up to 24 hr post-dose ] [ Designated as safety issue: No ]
  • Change from baseline of osteopontin after drug administration [ Time Frame: Pre-dose and up to 24 hr post-dose ] [ Designated as safety issue: No ]
  • Cyclic guanosine mono-phosphate [ Time Frame: Pre-dose and up to 24 hr post-dose ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Single Dose Escalation Study in Patients With Chronic Heart Failure
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.
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure
Drug: BAY60-4552
Single dose escalation planned at dose of 1 mg, 2.5 mg, 5 mg, 7.5 mg, and 10 mg
  • Experimental: BAY60-4552, 1 mg
    Subjects were planned to receive 1 mg of BAY60-4552 as solution
    Intervention: Drug: BAY60-4552
  • Experimental: BAY60-4552, 2.5 mg
    Subjects were planned to receive 2.5 mg of BAY60-4552 as tablet
    Intervention: Drug: BAY60-4552
  • Experimental: BAY60-4552, 5 mg
    Subjects were planned to receive 5.0 mg of BAY60-4552 as tablet
    Intervention: Drug: BAY60-4552
  • Experimental: BAY60-4552, 7.5 mg
    Subjects were planned to receive 7.5 mg of BAY60-4552 as tablet
    Intervention: Drug: BAY60-4552
  • Experimental: BAY60-4552, 10 mg
    Subjects were planned to receive 10 mg of BAY60-4552 as tablet
    Intervention: Drug: BAY60-4552
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
April 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00565565
12356, 2007-003216-54
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP