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WithdrawnNCT00664287Updated Apr 9, 2015

Extended Release (ER) Niacin/Laropiprant Add on Study (0524A-082)

A Phase 3 interventional study of niacin (+) laropiprant and placebo (unspecified) in Dyslipidemia, sponsored by Merck Sharp & Dohme LLC. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-09.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to test the effect of MK0524A (niacin (+) laropiprant) on lowering bad cholesterol and raising good cholesterol.

02

Conditions studied

  • Dyslipidemia

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03

In context

Dyslipidemias

1,101 studies on the registry are indexed under Dyslipidemias; 161 are open to participants now.

Browse Dyslipidemias studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.

Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients 18 years of age or older and on a stable dose of lipid therapy

Exclusion criteria

Exclusion Criteria:

  • Patients lipid level is outside the recommended range
  • Patients that are HIV positive
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Group 1

    Patients will remain on existing lipid-modifying therapy throughout the study. Group 1: Patients will receive ER niacin/laropiprant 1 g/20 mg daily. After 4 weeks, ER niacin/laropiprant will be increased to 2 g/40 mg for remainder of study.

    Drug: niacin (+) laropiprant

  • Placebo comparator
    Group 2

    Patients will remain on existing lipid-modifying therapy throughout the study. Group 2: Patients will receive 1 placebo tablet daily. After 4 weeks, patients will be advanced to 2 placebo tablets for remainder of the study.

    Drug: placebo (unspecified)

Interventions

  • Drugniacin (+) laropiprant

    Drug pages: Niacin · MK-0524

    Group 1: Patients will receive ER niacin/laropiprant 1 g/20 mg daily. After 4 weeks, ER niacin/laropiprant will be increased to 2 g/40 mg for remainder of study.

    Also known as: MK0524A

  • Drugplacebo (unspecified)

    Group 2: Patients will receive 1 placebo tablet daily. After 4 weeks, patients will be advanced to 2 placebo tablets for remainder of the study.

06

What researchers measure

Primary outcomes

  1. Lipid modification results of MK0524A (niacin (+) laropiprant) compared to placebo on LDL-C throughout the study and at 17 weeks.

    Time frame: 3 months

Secondary outcomes

  1. Lipid modification results of MK0524A (niacin (+) laropiprant) on blood lipids such as LDL-C, HDL-C, triglycerides, etc., throughout the study and at 17 weeks.

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00664287
Responsible party
Sponsor
First posted
Apr 22, 2008
Start date
Sep 2008
Primary completion
Nov 2009 (estimated)
Last update
Apr 9, 2015

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Niacin · MK-0524

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