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NCT00465088 · ClinicalTrials.gov registry record · Phase 3
An Open-Label Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia (SUPREME)
A Phase 3 study, sponsored by Abbott.
- Completed
- Registry status
- Phase 3
- Development phase
- 199
- Enrollment target
NCT00465088: Completed Phase 3 study, sponsored by Abbott.
NCT00465088 is a Phase 3 study that has completed, run by Abbott. The registered enrollment target is 199 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00465088, a Phase 3 study, has completed, sponsored by Abbott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 199 participants
- Enrollment target
Study Summary
To demonstrate that niacin ER and simvastatin (NS) tablets, when compared to atorvastatin (Lipitor®; Pfizer, Inc.), has superior high-density lipoprotein cholesterol (HDL-C) elevating effects at Week 12 in subjects with type II hyperlipidemia or mixed dyslipidemia who are currently off lipid-modifying therapy. This was a prospective, randomized, open-label, blinded endpoint (PROBE) study.
Primary Outcome
(Week 12 HDL-C minus baseline HDL-C) x 100/baseline HDL-C
Interventions
- DRUG atorvastatin
- DRUG Niacin ER/Simvastatin Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2007-04 |
| Phase | Phase 3 |
What the finished NCT00465088 record still lists
NCT00465088 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which atorvastatin is the first listed.
NCT00465088 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00465088 about?
NCT00465088 is a clinical study titled "An Open-Label Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia (SUPREME)". To demonstrate that niacin ER and simvastatin (NS) tablets, when compared to atorvastatin (Lipitor®; Pfizer, Inc.), has superior high-density lipoprotein cholesterol (HDL-C) elevating effects at Week 12 in subjects with type II hyperlipidemia or mixed dyslipidemia who are currently off lipid-modifyi...
What is the current status of trial NCT00465088?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 199 participants. The study started on 2007-04.
What interventions are being tested in trial NCT00465088?
The interventions under investigation include: atorvastatin (DRUG), Niacin ER/Simvastatin Tablets (DRUG).
Who is sponsoring clinical trial NCT00465088?
This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00465088's enrollment target sits among peer trials
199 1388th of 2000 higher than 612 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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