stop_circleTerminated/Withdrawn
Pharmacology, Clinical
Bayer Identifier:infoA unique number for a trial given by Bayer.
15138
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
Study on the safety of neladenoson bialanate, how it is tolerated and the way the body absorbs, distributes and gets rid of the study dug given as a single oral dose of 10 mg immediate release tablet in participants with renal impairment and healthy participants matched for age-, gender-, and weight
Trial purpose
Neladenoson bialanate is currently under clinical development for a condition in which the heart has trouble pumping blood through the body (chronic heart failure). Renal impairment which co-occurs in patients with heart failure is a common condition in which the kidneys are not filtering the blood as well as they should. The goal of the study is to learn more about the safety of neladenoson bialanate, how it is tolerated and the way the body absorbs, distributes and excretes the study dug given as a single oral dose of 10 mg immediate release tablet in participants with renal impairment and healthy participants matched for age-, gender-, and weight
Key Participants Requirements
Sex
AllAge
18 - 79 YearsTrial summary
Enrollment Goal info
18The overall number of participants needed for a trial.
Trial Dates info
November 2017 - December 2018Trial 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
Neladenoson Bialanate (BAY1067197)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
YesA 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 | CRS Clinical-Research-Services Kiel GmbH | Kiel, 24105, Germany |
Completed | APEX GmbH | München, 81241, Germany |
Withdrawn | SocraTec R&D Clinical Ward | Erfurt, 99084, 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.
- Cmax for BAY 84-3174Maximum observed drug concentration in measured matrix after single dose administrationdate_rangeTime Frame:Pre-dose up to approximately 6 weeks after dosing
- AUC for BAY 84-3174Area under the concentration vs. time curve from zero to infinity after single dose administrationdate_rangeTime Frame:Pre-dose up to approximately 6 weeks after dosing
- Cmax,norm for BAY 84-3174Cmax divided by dose per body weight after single dose administrationdate_rangeTime Frame:Pre-dose up to approximately 6 weeks after dosing
- AUCnorm for BAY 84-3174AUC divided by dose per body weight after single dose administrationdate_rangeTime Frame:Pre-dose up to approximately 6 weeks after dosing
- Cmax,u for BAY 84-3174Cmax of unbound drug after single dose administrationdate_rangeTime Frame:Pre-dose up to approximately 6 weeks after dosing
- AUCu for BAY 84-3174AUC of unbound drug after single dose administrationdate_rangeTime Frame:Pre-dose up to approximately 6 weeks after dosing
- fu for BAY 84-3174Fraction of free (unbound) drug in plasma or serum after single dose administrationdate_rangeTime Frame:At 4 hours after dosing
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.
- Number of subjects with treatment-emergent adverse events (TEAEs)date_rangeTime Frame:Up to approximately 6 weeks after dosing
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
Basic ScienceThe 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
N/A“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
Parallel AssignmentAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
4A “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.