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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508447-52-00 | Registry Identifier | CTIS (EU) |
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Heart failure is a condition in which the heart does not pump blood as well as it should. It can happen in both adults and children. The study treatment, vericiguat, also called BAY1021189, is already approved for doctors to give to adults who have heart failure, particularly those with an ejection fraction (EF) reduced to less than 45%. An EF is a measurement, expressed as a percentage, of how much blood is pumped with each heartbeat. An EF of less than 45% indicates a reduced ability of the heart to pump blood effectively. This results in a reduced supply of the oxygen that the body requires to function properly.
Vericiguat works by increasing the activity of a protein called soluble guanylate cyclase (sGC). sGC helps widen blood vessels, which in turn improves the heart function. Vericiguat is currently only available as a treatment for adults. Researchers think vericiguat could help treat children with heart failure and it will be easier for them to take a liquid treatment.
The main purpose of this study is to find out how the taste of the liquid form of vericiguat for children changes when different amounts of flavor improvers are added.
During the study, participants will take 5 different study drugs in different orders. They will take:
Participants will taste these formulations or placebo but will not swallow them.
During the study, the doctors and their study team will:
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention sequence 1 | Experimental | Subjects will receive 5 different formulations in sequence No. 1. The intervention administrations will be separated by a washout phase of 24 h. |
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| Intervention sequence 2 | Experimental | Subjects will receive 5 different formulations in sequence No. 2. The intervention administrations will be separated by a washout phase of 24 h. |
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| Intervention sequence 3 | Experimental | Subjects will receive 5 different formulations in sequence No. 3. The intervention administrations will be separated by a washout phase of 24 h. |
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| Intervention sequence 4 | Experimental | Subjects will receive 5 different formulations in sequence No. 4. The intervention administrations will be separated by a washout phase of 24 h. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formulation 1 | Drug | Oral suspension of Vericiguat (BAY1021189) in single dose (SD). |
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| Measure | Description | Time Frame |
|---|---|---|
| Taste questionnaire by means of descriptive statistics | The sensory data will be collected on an ordinale scale, with higher scores indicating greater intensity of that sensory characteristic. The scores will be analyzed to determine the taste profile of each oral suspension for the key sensory characteristics and how the taste profiles of the suspensions compare to one another. | Directly after study intervention administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Services | Clinical Research Services Mannheim - Phase one unit | Mannheim | Baden-Wurttemberg | 68167 | Germany |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C515423 | Akacid-medical-formulation |
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| Intervention sequence 5 | Experimental | Subjects will receive 5 different formulations in sequence No. 5. The intervention administrations will be separated by a washout phase of 24 h. |
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| Formulation 2 | Drug | Oral suspension of Vericiguat (BAY1021189) with increased level of sucralose in SD. |
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| Formulation 3 | Drug | Oral suspension of Vericiguat (BAY1021189) with increased level of flavor in SD. |
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| Formulation 4 | Drug | Oral suspension of Vericiguat (BAY1021189) with increased level of sucralose and flavor in SD. |
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| Formulation 5 (placebo) | Drug | Matching placebo of formulation 1 in SD. |
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