Try our beta test site

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
Not Provided
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 ]
  • Change in mean pulmonary artery pressure [ Time Frame: Pre-dose and up to 6 hr post-dose ]
  • 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
  • AUC/D [ Time Frame: Pre-dose and up to 72 hr post-dose ]
    AUC divided by dose (mg)
  • Cmax [ Time Frame: Pre-dose and up to 72 hr post-dose ]
    Maximum drug concentration in plasma after single dose administration
  • Cmax/D [ Time Frame: Pre-dose and up to 72 hr post-dose ]
    Cmax divided by dose (mg)
  • Number of participants with adverse events [ Time Frame: Approximately 2 weeks ]
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 ]
No Changes Posted
  • Mean right atrial pressure [ Time Frame: Pre-dose and up to 6 hr post-dose ]
  • Systolic pulmonary artery pressure [ Time Frame: Pre-dose and up to 6 hr post-dose ]
  • Diastolic pulmonary artery pressure [ Time Frame: Pre-dose and up to 6 hr post-dose ]
  • Heart rate [ Time Frame: At pre-study visit, pre-dose and up to 24 hr post-dose ]
  • Cardiac output [ Time Frame: Pre-dose and up to 6 hr post-dose ]
  • Pulmonary vascular resistance [ Time Frame: Pre-dose and up to 6 hr post-dose ]
  • Pulmonary vascular resistance index [ Time Frame: Pre-dose and up to 6 hr post-dose ]
  • Systemic vascular resistance [ Time Frame: Pre-dose and up to 6 hr post-dose ]
  • Systemic vascular resistance index [ Time Frame: Pre-dose and up to 6 hr post-dose ]
  • Cardiac index [ Time Frame: Pre-dose and up to 6 hr post-dose ]
  • Mean arterial pressure [ Time Frame: Pre-dose and up to 6 hr post-dose ]
  • Systemic blood pressure [ Time Frame: At pre-study visit, pre-dose and up to 24 hr post-dose ]
  • Diastolic blood pressure [ Time Frame: At pre-study visit, pre-dose and up to 24 hr post-dose ]
  • 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.
  • 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
  • AUCnorm [ Time Frame: Pre-dose and up to 72 hr post-dose ]
    AUC divided by dose (mg) per kg body weight
  • AUC(0-tn) [ Time Frame: Pre-dose and up to 72 hr post-dose ]
    AUC from time 0 to the last data point
  • 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
  • Cmax,norm [ Time Frame: Pre-dose and up to 72 hr post-dose ]
    Cmax divided by dose (mg) per kg body weight
  • tmax [ Time Frame: Pre-dose and up to 72 hr post-dose ]
    Time to reach maximum drug concentration in plasma after single dose
  • t½ [ Time Frame: Pre-dose and up to 72 hr post-dose ]
    Half-life associated with the terminal slope
  • Mean residence time [ Time Frame: Pre-dose and up to 72 hr post-dose ]
  • 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 ]
  • Apparent volume of distribution associated with the terminal phase (after oral administration) [ Time Frame: Pre-dose and up to 72 hr post-dose ]
  • Amount of drug excreted via urine [ Time Frame: Pre-dose and up to 6 hr post-dose ]
  • Percent amount of drug excreted via urine [ Time Frame: Pre-dose and up to 6 hr post-dose ]
  • Renal clearance of drug [ Time Frame: Pre-dose and up to 6 hr post-dose ]
  • Renin activity [ Time Frame: Pre-dose and up to 24 hr post-dose ]
  • Change from baseline of noradrenaline after drug administration [ Time Frame: Pre-dose and up to 24 hr post-dose ]
  • N-terminal pro-atrial natriuretic peptide [ Time Frame: Pre-dose and up to 24 hr post-dose ]
  • NT-pro B-type natriuretic peptide [ Time Frame: Pre-dose and up to 24 hr post-dose ]
  • Big endothelin-1 [ Time Frame: Pre-dose and up to 24 hr post-dose ]
  • Cystatin C [ Time Frame: Pre-dose and up to 24 hr post-dose ]
  • Change from baseline of osteopontin after drug administration [ Time Frame: Pre-dose and up to 24 hr post-dose ]
  • Cyclic guanosine mono-phosphate [ Time Frame: Pre-dose and up to 24 hr post-dose ]
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
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
Sexes Eligible for Study: All
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
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