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NCT03617263 · ClinicalTrials.gov registry record · Phase 2
Saroglitazar Magnesium 4 mg in the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Women With PCOS (EVIDENCES VII)
A Phase 2 study, sponsored by Zydus Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT03617263 is a Phase 2 study that was terminated before completion, run by Zydus Therapeutics. The registered enrollment target is 60 participants.
The verdict
NCT03617263, a Phase 2 study, was terminated before completion, sponsored by Zydus Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium in women with well characterized PCOS.
Interventions
- DRUG Placebo
- DRUG Saroglitazar Magnesium 4 mg Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-02-12 |
| Est. Completion | 2024-10-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03617263
The ClinicalTrials.gov registry entry for NCT03617263 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zydus Therapeutics, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03617263 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03617263 about?
NCT03617263 is a clinical study titled "Saroglitazar Magnesium 4 mg in the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Women With PCOS (EVIDENCES VII)". This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium in women with well characterized PCOS.
What is the current status of trial NCT03617263?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2019-02-12. Estimated completion is 2024-10-28.
What interventions are being tested in trial NCT03617263?
The interventions under investigation include: Placebo (DRUG), Saroglitazar Magnesium 4 mg Tablet (DRUG).
Who is sponsoring clinical trial NCT03617263?
This trial is sponsored by Zydus Therapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.
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