Phase 3 N=1,216 Randomized Double-blind Treatment

Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)

Primary Hypercholesterolemia · Mixed Dyslipidemia

Bottom Line

View on ClinicalTrials.gov: NCT00479388 ↗

Enrolled (actual)

1,216

Serious AEs

—

Results posted

Jul 2009

Primary outcome: Primary: Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12 — -10.0; -5.5 Percent — p=0.006

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Comparator: simvastatin (Drug); niacin (+) laropiprant (Drug); Comparator: atorvastatin calcium (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Jul 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12	-10.0; -5.5	0.006 sig
SECONDARY Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12	15.8; 0.2	<=0.001 sig
SECONDARY Percent Change From Baseline in Triglycerides at Week 12	-17.6; -4.0	<=0.001 sig

Summary

This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed dyslipidemia to study the effects of ER niacin/laropiprant on lipids.

Eligibility Criteria

Inclusion Criteria

Patients 18 to 80 years of age with Primary hypercholesterolemia or mixed dyslipidemia
Patients will be eligible for the study if their LDL-C values are within protocol specified range and meet other entry criteria

Exclusion Criteria

Patient whose LDL-C values are not within protocol specified range

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00479388). 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.