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NCT03694197 · ClinicalTrials.gov registry record · Phase 4
Long Term Safety Study of PRALUENT
A Phase 4 study, sponsored by Regeneron Pharmaceuticals.
- Terminated
- Registry status
- Phase 4
- Development phase
- 1,389
- Enrollment target
NCT03694197 is a Phase 4 study that was terminated before completion, run by Regeneron Pharmaceuticals. The registered enrollment target is 1,389 participants.
The verdict
NCT03694197, a Phase 4 study, was terminated before completion, sponsored by Regeneron Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 1,389 participants
- Enrollment target
Study Summary
The primary objective of the study was to evaluate the long term safety of PRALUENT in participants with heterozygous familial hypercholesterolemia (heFH) or non-familial hypercholesterolemia (FH) participants at high or very high cardiovascular risk who completed the neurocognitive function study R727-CL-1532 (NCT02957682). The secondary objectives of the study were: * To evaluate the effect of PRALUENT on low-density lipoprotein cholesterol (LDL-C) * To evaluate the effect of PRALUENT on other lipid parameters * To evaluate the effect of PRALUENT on gonadal steroid hormones
Interventions
- DRUG Praluent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,389 participants |
| Start Date | 2018-09-28 |
| Est. Completion | 2020-04-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03694197
The ClinicalTrials.gov registry entry for NCT03694197 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 1,389 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Praluent is the first listed.
NCT03694197 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03694197 about?
NCT03694197 is a clinical study titled "Long Term Safety Study of PRALUENT". The primary objective of the study was to evaluate the long term safety of PRALUENT in participants with heterozygous familial hypercholesterolemia (heFH) or non-familial hypercholesterolemia (FH) participants at high or very high cardiovascular risk who completed the neurocognitive function study R...
What is the current status of trial NCT03694197?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1,389 participants. The study started on 2018-09-28. Estimated completion is 2020-04-08.
What interventions are being tested in trial NCT03694197?
The interventions under investigation include: Praluent (DRUG).
Who is sponsoring clinical trial NCT03694197?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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