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NCT02597127 · ClinicalTrials.gov registry record · Phase 2
Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C)
A Phase 2 study, sponsored by The Medicines Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 501
- Enrollment target
NCT02597127: Completed Phase 2 study, sponsored by The Medicines Company.
NCT02597127 is a Phase 2 study that has completed, run by The Medicines Company. The registered enrollment target is 501 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (277% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02597127, a Phase 2 study, has completed, sponsored by The Medicines Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 501 participants
- Enrollment target
Study Summary
This study is a Phase II, placebo-controlled, double-blind, randomized trial in 480 participants with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (for example, diabetes and familial hypercholesterolemia) and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of ALN-PCSSC injection(s).
Primary Outcome
Percent Change in LDL-C (beta-quantification) from Baseline to Day 180 in MITT Population
Interventions
- DRUG Normal Saline
- DRUG ALN-PCSSC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 501 participants |
| Start Date | 2016-01 |
| Est. Completion | 2017-06-07 |
| Phase | Phase 2 |
What the finished NCT02597127 record still lists
NCT02597127 is an interventional study that assigns participants to a tested intervention. The registered 501 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (277% higher).
The record links to 0 conditions, and to 2 interventions - of which Normal Saline is the first listed.
NCT02597127 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02597127 about?
NCT02597127 is a clinical study titled "Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C)". This study is a Phase II, placebo-controlled, double-blind, randomized trial in 480 participants with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (for example, diabetes and familial hypercholesterolemia) and elevated LDL-C despite maximum tolerated dose of LDL-C lowering...
What is the current status of trial NCT02597127?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 501 participants. The study started on 2016-01. Estimated completion is 2017-06-07.
What interventions are being tested in trial NCT02597127?
The interventions under investigation include: Normal Saline (DRUG), ALN-PCSSC (DRUG).
Who is sponsoring clinical trial NCT02597127?
This trial is sponsored by The Medicines Company, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02597127's enrollment target sits among peer trials
501 70th of 2000 higher than 1,931 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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