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NCT03398005 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 STudy of CaPRe In LOwering Very hiGh TriglYcerides (TRILOGY 1)
A Phase 3 study, sponsored by Grace Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 256
- Enrollment target
NCT03398005 is a Phase 3 study that has completed, run by Grace Therapeutics. The registered enrollment target is 256 participants.
The verdict
NCT03398005, a Phase 3 study, has completed, sponsored by Grace Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 256 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine the efficacy of CaPre 4 g daily, compared to placebo, in lowering fasting triglyceride (TG) levels in patients with fasting TG levels ≥500 mg/dL and ≤1500 mg/dL (≥5.7 mmol/L and ≤17.0 mmol/L) after 12 weeks of treatment. Approximately 615 subjects will be screened to obtain 245 randomized subjects following a 2.5:1 treatment allocation ratio (CaPre: placebo).
Interventions
- DRUG Placebo
- DRUG CaPre
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2018-01-23 |
| Est. Completion | 2019-11-20 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03398005
The ClinicalTrials.gov registry entry for NCT03398005 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 256 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grace Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03398005 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03398005 about?
NCT03398005 is a clinical study titled "A Phase 3 STudy of CaPRe In LOwering Very hiGh TriglYcerides (TRILOGY 1)". The primary objective of this study is to determine the efficacy of CaPre 4 g daily, compared to placebo, in lowering fasting triglyceride (TG) levels in patients with fasting TG levels ≥500 mg/dL and ≤1500 mg/dL (≥5.7 mmol/L and ≤17.0 mmol/L) after 12 weeks of treatment. Approximately 615 subjects...
What is the current status of trial NCT03398005?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 256 participants. The study started on 2018-01-23. Estimated completion is 2019-11-20.
What interventions are being tested in trial NCT03398005?
The interventions under investigation include: Placebo (DRUG), CaPre (DRUG).
Who is sponsoring clinical trial NCT03398005?
This trial is sponsored by Grace Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
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