Phase 3
Completed N=1,152
A Long-term Study of ERN/LRPT (Extended Release Niacin/Laropiprant [MK0524A]) in Patients With Dyslipidemia (0524A-102)
Source: ClinicalTrials.gov NCT00961636 ↗Enrolled (actual)
1,152
Serious AEs
5.6%
Results posted
Feb 2012
Primary outcomePrimary: Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period — 291; 181; 188; 43 Participants — p=<0.001
Summary
This study will evaluate the efficacy of laropiprant (LRPT) to reduce flushing symptoms beyond 6 months and will measure the impact of withdrawal of laropiprant in patients following 20 weeks of stable maintenance therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period |
291; 181; 188; 43; 74; 7 | <0.001 sig |
| SECONDARY Number of Participants With Maximum GFSS ≥4 During the Post-withdrawal Period |
71; 173; 19 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patient is a male, or a female who is unlikely to conceive, as indicated by meeting at least one of the following conditions: (a) Patient is a male.(b) Patient is a female of reproductive potential and either agrees to remain abstinent (if this form of birth control is accepted by local regulatory agencies and review committees as the sole method of birth control) or use (or have their partner use) 2 acceptable methods of birth control within the projected duration of the study.(c) Patient is a female who is not of reproductive potential and therefore eligible to participate in this study without requiring the use of contraception.
- Lipid-modifying therapy (LMT) is appropriate for the patient
- Patient meets one of the following criteria based on the National Cholesterol Education Program Adult Treatment Panel III guidelines : 1) High risk and is on a statin with LDL-cholesterol (LDL-C) 50 mg daily within 6 weeks of screening
- Patient has had a change to type or dose of LMT regimen within 6 weeks of Visit 1
- Patient is taking a statin and a fibrate at screening
- Patient is taking a long acting non-steroidal anti-inflammatory drug (NSAID), such as naproxen or aspirin >100 mg per day at screening
- Patient has arterial bleeding
Data sourced from ClinicalTrials.gov (NCT00961636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.