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NCT04320771
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
Phase 1 trial testing Neladenoson bialanate (BAY 1067197) in Pharmacology, Clinical in 18 participants. Terminated before completion.
8 August 2018
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 18 |
| Start date | 2 November 2017 |
| Primary completion | 8 August 2018 |
| Estimated completion | 17 December 2018 |
| Sites | 2 locations across Germany |
Drugs / interventions tested
- Neladenoson bialanate (BAY 1067197) — full drug profile →
Conditions studied
- Pharmacology, Clinical — all drugs for Pharmacology, Clinical →
Sponsor
Bayer — full company profile →
Who can join
Adults 18 to 79, any sex, with Pharmacology, Clinical. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Adenosine receptors as promising targets for the management of ocular diseases.
Spinozzi E, Baldassarri C, Acquaticci L, Del Bello F, et al · · 2021 · cited 13× · PMID 33519168 · DOI 10.1007/s00044-021-02704-x
Verify or expand the search:
- PubMed search for NCT04320771
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Neladenoson bialanate (BAY 1067197)
Trials testing the same drug.
- NCT04322253 — Study on the Safety of Neladenoson Bialanate, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid · Phase 1 · terminated
Other Bayer trials
Trials by the same sponsor.
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- NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
- NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04320771 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 26 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04320771.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing