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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 is a Phase 3 study that has completed, run by Abbott. The registered enrollment target is 199 participants.
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.
Interventions
- DRUG atorvastatin
- DRUG Niacin ER/Simvastatin Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2007-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00465088
The ClinicalTrials.gov registry entry for NCT00465088 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 199 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott, which has 181 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which atorvastatin is the first listed.
NCT00465088 reports 0 study locations.
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.
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