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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: Clinical Trial Phase 4 study, sponsored by Regeneron Pharmaceuticals.
NCT03694197 is a Phase 4 study that was terminated before completion, run by Regeneron Pharmaceuticals. The registered enrollment target is 1,389 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (168% higher). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
An AE is any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. AEs include serious adverse events (SAEs), AEs leading to treatment discontinuation, and adverse events of special interest (AESI). AESI include local injection site reactions, general allergic events, elevated alanine aminotransferase (ALT) levels greater than or equal to (≥) 3 upper limit normal (ULN) (if baseline is less than (\<) ULN)/ALT ≥2
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 |
Why NCT03694197 stopped before completion
NCT03694197 is an interventional study that assigns participants to a tested intervention. Its 1,389 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (168% higher).
The record links to 0 conditions, and to 1 intervention - of which Praluent is the first listed.
NCT03694197 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03694197's enrollment target sits among peer trials
1,389 55th of 2000 higher than 1,946 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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