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MK0524A Clinical Efficacy Study (0524A-026)(COMPLETED)

A Multicenter, Randomized, Double-Blinded, Parallel-Design Study to Evaluate the Lipid-Altering Efficacy of 2 Formulations of MK0524A Compared to NIASPAN (TM)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00533312
Enrollment
407
Registered
2007-09-21
Start date
2005-04-30
Completion date
2007-01-31
Last updated
2017-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Brief summary

A study to determine lipid changing effects of MK0524A when compared to niacin extended release (NIASPAN) and placebo.

Interventions

DRUGComparator : placebo (unspecified) / Duraton of Treatment: 4 Weeks
DRUGMK0524A, niacin (+) laropiprant / Duration of Treatment : 4 Weeks
DRUGComparator : niacin / Duraton of Treatment: 4 Weeks

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Patients must be between the ages of 18 and 70 years * Female patients must be pre-menopausal women that have been surgically sterilized, not pregnant and/or not planning to become pregnant

Exclusion criteria

* Patient has a history of peptic ulcer or gout * Patient is sensitive to niacin or products containing niacin * Patient drinks more than 2 alcoholic drinks per day * Patient has certain heart disease, cancer, or is HIV positive

Design outcomes

Primary

MeasureTime frame
To assess the HDL-C raising efficacy of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.After 4 weeks

Secondary

MeasureTime frame
To asses the triglyceride-lowering effects of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.After 4 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026