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NCT03411980 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics and Safety of Vilaprisan in Renal Impairment
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT03411980: Completed Phase 1 study, sponsored by Bayer.
NCT03411980 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03411980, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the pharmacokinetics of vilaprisan in subjects with moderate to severe renal impairment compared with matched subjects with normal renal function.
Primary Outcome
Area under the concentration versus time curve from zero to the last data point above the lower limit of quantitation \[AUC(0-tlast)\], if AUC cannot be estimated in all subjects. In subjects with normal and moderately reduced renal function.
Interventions
- DRUG Vilaprisan (BAY1002670)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2018-02-02 |
| Est. Completion | 2019-02-06 |
| Phase | Phase 1 |
What the finished NCT03411980 record still lists
NCT03411980 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which Vilaprisan (BAY1002670) is the first listed.
NCT03411980 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03411980 about?
NCT03411980 is a clinical study titled "Pharmacokinetics and Safety of Vilaprisan in Renal Impairment". The purpose of the study is to evaluate the pharmacokinetics of vilaprisan in subjects with moderate to severe renal impairment compared with matched subjects with normal renal function.
What is the current status of trial NCT03411980?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2018-02-02. Estimated completion is 2019-02-06.
What interventions are being tested in trial NCT03411980?
The interventions under investigation include: Vilaprisan (BAY1002670) (DRUG).
Who is sponsoring clinical trial NCT03411980?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03411980's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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