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NCT04609943
Study to Find the Highest Safe Dose of Soluble Guanylate Cyclase (sGC) Activator, BAY 1211163 Administered as Multiple Doses by Inhalation to Patients Who Cannot Breathe by Their Own and Suffer From a Type of Lung Failure That Causes Fluid to Build up in the Lungs Making Breathing Difficult (ARDS)
Phase 1 trial testing BAY1211163 in Acute Respiratory Distress Syndrome in 16 participants. Terminated before completion.
17 August 2023
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 24 November 2020 |
| Primary completion | 17 August 2023 |
| Estimated completion | 14 September 2023 |
| Sites | 4 locations across Germany |
Drugs / interventions tested
- BAY1211163 — full drug profile →
Conditions studied
- Acute Respiratory Distress Syndrome — all drugs for Acute Respiratory Distress Syndrome →
Sponsor
Bayer — full company profile →
Who can join
18 and older, any sex, with Acute Respiratory Distress Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
With this study researchers want to find the highest safe dose of the soluble Guanylate Cyclase (sGC) Activator, BAY 1211163 and how safe and well the study drug works. Furthermore researchers want to gather information on the way the body absorbs, distributes and gets rid of the study drug given as increasing multiple doses by inhalation to patients who cannot breathe by their own and suffer from a type of lung failure that causes fluid to build up in the lungs making breathing difficult (ARDS)
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Endogenous Hemoprotein-Dependent Signaling Pathways of Nitric Oxide and Nitrite.
Dent MR, DeMartino AW, Tejero J, Gladwin MT. · · 2021 · cited 25× · PMID 34313417 · DOI 10.1021/acs.inorgchem.1c01048
Verify or expand the search:
- PubMed search for NCT04609943
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04609943 (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: 19 September 2024
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/NCT04609943.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing