check_circleStudy Completed
Heart Failure
Bayer Identifier:
12356
ClinicalTrials.gov Identifier:
EudraCT Number:
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
BothAge
18 - N/ATrial summary
Enrollment Goal
55Trial Dates
October 2007 - April 2009Phase
Phase 1Could I Receive a placebo
NoProducts
Nelociguat (BAY60-4552)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Gießen, 35392, Germany | |
Completed | Bad Nauheim, 61231, Germany |
Primary Outcome
- Change in pulmonary capillary wedge pressuredate_rangeTime Frame:Pre-dose and up to 6 hr post-doseenhanced_encryptionNoSafety Issue:
- Change in mean pulmonary artery pressuredate_rangeTime Frame:Pre-dose and up to 6 hr post-doseenhanced_encryptionNoSafety Issue:
- AUCArea under the plasma concentration vs time curve from zero to infinity after single dosedate_rangeTime Frame:Pre-dose and up to 72 hr post-doseenhanced_encryptionNoSafety Issue:
- AUC/DAUC divided by dose (mg)date_rangeTime Frame:Pre-dose and up to 72 hr post-doseenhanced_encryptionNoSafety Issue:
- CmaxMaximum drug concentration in plasma after single dose administrationdate_rangeTime Frame:Pre-dose and up to 72 hr post-doseenhanced_encryptionNoSafety Issue:
- Cmax/DCmax divided by dose (mg)date_rangeTime Frame:Pre-dose and up to 72 hr post-doseenhanced_encryptionNoSafety Issue:
- Number of participants with adverse eventsdate_rangeTime Frame:Approximately 2 weeksenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Mean right atrial pressuredate_rangeTime Frame:Pre-dose and up to 6 hr post-doseenhanced_encryptionNoSafety Issue:
- Systolic pulmonary artery pressuredate_rangeTime Frame:Pre-dose and up to 6 hr post-doseenhanced_encryptionNoSafety Issue:
- Diastolic pulmonary artery pressuredate_rangeTime Frame:Pre-dose and up to 6 hr post-doseenhanced_encryptionNoSafety Issue:
- Heart ratedate_rangeTime Frame:At pre-study visit, pre-dose and up to 24 hr post-doseenhanced_encryptionYesSafety Issue:
- Cardiac outputdate_rangeTime Frame:Pre-dose and up to 6 hr post-doseenhanced_encryptionNoSafety Issue:
- Pulmonary vascular resistancedate_rangeTime Frame:Pre-dose and up to 6 hr post-doseenhanced_encryptionNoSafety Issue:
- Pulmonary vascular resistance indexdate_rangeTime Frame:Pre-dose and up to 6 hr post-doseenhanced_encryptionNoSafety Issue:
- Systemic vascular resistancedate_rangeTime Frame:Pre-dose and up to 6 hr post-doseenhanced_encryptionNoSafety Issue:
- Systemic vascular resistance indexdate_rangeTime Frame:Pre-dose and up to 6 hr post-doseenhanced_encryptionNoSafety Issue:
- Cardiac indexdate_rangeTime Frame:Pre-dose and up to 6 hr post-doseenhanced_encryptionNoSafety Issue:
- Mean arterial pressuredate_rangeTime Frame:Pre-dose and up to 6 hr post-doseenhanced_encryptionNoSafety Issue:
- Systemic blood pressuredate_rangeTime Frame:At pre-study visit, pre-dose and up to 24 hr post-doseenhanced_encryptionYesSafety Issue:
- Diastolic blood pressuredate_rangeTime Frame:At pre-study visit, pre-dose and up to 24 hr post-doseenhanced_encryptionYesSafety Issue:
- Dyspnea ScoreSubject 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-doseenhanced_encryptionNoSafety Issue:
- AUC(0-6)AUC from time 0 to 6 h after study drug intakedate_rangeTime Frame:Pre-dose and up to 6 hr post-doseenhanced_encryptionNoSafety Issue:
- AUCnormAUC divided by dose (mg) per kg body weightdate_rangeTime Frame:Pre-dose and up to 72 hr post-doseenhanced_encryptionNoSafety Issue:
- AUC(0-tn)AUC from time 0 to the last data pointdate_rangeTime Frame:Pre-dose and up to 72 hr post-doseenhanced_encryptionNoSafety Issue:
- AUC(0-tn)normAUC(0-tn) divided by dose (mg) per kg body weightdate_rangeTime Frame:Pre-dose and up to 72 hr post-doseenhanced_encryptionNoSafety Issue:
- Cmax,normCmax divided by dose (mg) per kg body weightdate_rangeTime Frame:Pre-dose and up to 72 hr post-doseenhanced_encryptionNoSafety Issue:
- tmaxTime to reach maximum drug concentration in plasma after single dosedate_rangeTime Frame:Pre-dose and up to 72 hr post-doseenhanced_encryptionNoSafety Issue:
- t½Half-life associated with the terminal slopedate_rangeTime Frame:Pre-dose and up to 72 hr post-doseenhanced_encryptionNoSafety Issue:
- Mean residence timedate_rangeTime Frame:Pre-dose and up to 72 hr post-doseenhanced_encryptionNoSafety Issue:
- 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-doseenhanced_encryptionNoSafety Issue:
- Apparent volume of distribution associated with the terminal phase (after oral administration)date_rangeTime Frame:Pre-dose and up to 72 hr post-doseenhanced_encryptionNoSafety Issue:
- Amount of drug excreted via urinedate_rangeTime Frame:Pre-dose and up to 6 hr post-doseenhanced_encryptionNoSafety Issue:
- Percent amount of drug excreted via urinedate_rangeTime Frame:Pre-dose and up to 6 hr post-doseenhanced_encryptionNoSafety Issue:
- Renal clearance of drugdate_rangeTime Frame:Pre-dose and up to 6 hr post-doseenhanced_encryptionNoSafety Issue:
- Renin activitydate_rangeTime Frame:Pre-dose and up to 24 hr post-doseenhanced_encryptionNoSafety Issue:
- Change from baseline of noradrenaline after drug administrationdate_rangeTime Frame:Pre-dose and up to 24 hr post-doseenhanced_encryptionNoSafety Issue:
- N-terminal pro-atrial natriuretic peptidedate_rangeTime Frame:Pre-dose and up to 24 hr post-doseenhanced_encryptionNoSafety Issue:
- NT-pro B-type natriuretic peptidedate_rangeTime Frame:Pre-dose and up to 24 hr post-doseenhanced_encryptionNoSafety Issue:
- Big endothelin-1date_rangeTime Frame:Pre-dose and up to 24 hr post-doseenhanced_encryptionNoSafety Issue:
- Cystatin Cdate_rangeTime Frame:Pre-dose and up to 24 hr post-doseenhanced_encryptionNoSafety Issue:
- Change from baseline of osteopontin after drug administrationdate_rangeTime Frame:Pre-dose and up to 24 hr post-doseenhanced_encryptionNoSafety Issue:
- Cyclic guanosine mono-phosphatedate_rangeTime Frame:Pre-dose and up to 24 hr post-doseenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
5Additional Information
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