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A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the Lipid-Altering Efficacy, Safety and Tolerability of MK-0524A in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia - MK-0524A Lipid/Flushing Study

A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the Lipid-Altering Efficacy, Safety and Tolerability of MK-0524A in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia - MK-0524A Lipid/Flushing Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-005093-70-SE
Enrollment
1620
Registered
2005-11-09
Start date
2005-12-29
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Hypercholesterolaemia MedDRA version: 8.0 Level: LLT Classification code 10020603

Interventions

Product Name: MK-0524A (ER-Niacin/MK-0524) 1g/20mg Tablets or MK-0524A Product Code: MK-0524A (ER-Niacin/MK-0524) 1g/20mg or MK-0524A Pharmaceutical Form: Tablet INN or Proposed INN: MK-0524 or L-0008

Sponsors

Merck Sharp & Dohme (Sweden) AB
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient has a history of primary hypercholesterolemia or mixed hyperlipidemia. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient’s participation for the full duration of the study, or is not in the best interest of the patient to participate.

Design outcomes

Primary

MeasureTime frame
Main Objective: In patients with primary hypercholesterolemia or mixed hyperlipidemia: Evaluate the efficacy of MK-0524A 2g relative to placebo on plasma concentrations of low-density lipoprotein cholesterol (LDL-C). ;Secondary Objective: In patients with primary hypercholesterolemia or mixed hyperlipidemia: Assess the effects of MK 0524A relative to ER-niacin on flushing during the acute dosing period when measured by maximum Global Flushing Severity Score (GFSS) categorized into none/mild, moderate, severe, extreme during the first week of treatment. ;Primary end point(s): The main hypotheses involve assessments of plasma lipid/lipoproteins and flushing symptoms. Flushing symptoms are measured through patient report on electronic diaries and specifically with the GFSS. GFSS is one of the questions on the FSQ developed for this clinical program. It assesses the patient's overall severity of the flushing experience of redness, warmth, tingling and itching measured using an 11-point Likert scale (0=None, 1-3=Mild, 4-6=Moderate, 7-9=Severe, 10=Extreme).—

Countries

Finland, Germany, Italy, Spain, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026