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NCT03804879 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability and Efficacy of Nidufexor in Patients With Diabetic Nephropathy
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 83
- Enrollment target
NCT03804879 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 83 participants.
The verdict
NCT03804879, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 83 participants
- Enrollment target
Study Summary
Nidufexor addresses fibrosis, oxidative stress, inflammation and cell death, and therefore has the potential to improve the management of diabetic kidney disease when added to the standard of care (SoC) (angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)). This non-confirmatory Phase 2 study was designed to determine the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of nidufexor in combination with ACEI or ARB at a dose level that is SoC as judged by the study doctor in patients with type 2 diabetes and nephropathy.
Interventions
- OTHER Placebo
- DRUG Nidufexor
- DRUG Standard of Care (SoC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2018-12-17 |
| Est. Completion | 2021-05-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03804879
The ClinicalTrials.gov registry entry for NCT03804879 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03804879 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03804879 about?
NCT03804879 is a clinical study titled "Safety, Tolerability and Efficacy of Nidufexor in Patients With Diabetic Nephropathy". Nidufexor addresses fibrosis, oxidative stress, inflammation and cell death, and therefore has the potential to improve the management of diabetic kidney disease when added to the standard of care (SoC) (angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)). This non...
What is the current status of trial NCT03804879?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2018-12-17. Estimated completion is 2021-05-03.
What interventions are being tested in trial NCT03804879?
The interventions under investigation include: Placebo (OTHER), Nidufexor (DRUG), Standard of Care (SoC) (DRUG).
Who is sponsoring clinical trial NCT03804879?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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