check_circleStudy Completed
Heart Failure
Bayer Identifier:infoA unique number for a trial given by Bayer.
12356
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
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 info
55The overall number of participants needed for a trial.
Trial Dates info
October 2007 - April 2009Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 1A phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
Nelociguat (BAY60-4552)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
| Status | Institution | Location |
|---|---|---|
Completed | Gießen, 35392, Germany | |
Completed | Bad Nauheim, 61231, Germany |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- 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 OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- 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 info
InterventionalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
TreatmentThe main reason the clinical trial is being done.
Allocation info
Non-randomizedAllocation is the way treatments are assigned to the people in the trial.
Blinding info
Open Label“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
Single Group AssignmentAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
5A “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.
Additional Information
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