A Phase 3 interventional study of MK-0524A and ER Niacin in Hypercholesteremia and Hyperlipidemia, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-02-16.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment
This is a 12-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the efficacy of MK0524 to improve the tolerability of extended-release niacin. There will be 6 scheduled clinic visits and 3 treatment arms.
821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.
This study's enrollment of 825 is above the median of 87 across 691 interventional studies indexed under Hyperlipidemias.
Browse Hyperlipidemias studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A Placebo for 5 days (drug holiday) followed by MK-0524A 2 g for the remainder of the study (7 days).
Drug: MK-0524A · Drug: Placebo
Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A Placebo for 5 days (drug holiday) followed by ER-Niacin 2g for the remainder of the study (7 days)
Drug: ER Niacin · Drug: Placebo
Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A 2g for the remainder of the study (approximately 2 weeks).
Drug: MK-0524A
Global Flushing Severity Score (GFSS) during 7 days of treatment
Time frame: during 7 days of treatment
Percentage of Participants Who Experience at Least 1 Adverse Event
Time frame: up to 10 weeks
Percentage of Participants Who Were Discontinued from the Study Due to an Adverse Event
Time frame: up to 10 weeks
No study locations are listed for this record.
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC