A Worldwide, Double-Blind, Randomized, Placebo-Controlled Study of MK-0524A 2g Coadministered with Intensive LDL-C Lowering Therapy Compared to Intensive LDL-C Lowering Therapy Alone on Carotid Artery Intima Medial Thickening (cIMT) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH). - Carotid IMT Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001913-13-DE

Enrollment

900

Registered

2006-10-02

Start date

2006-11-29

Completion date

Unknown

Last updated

2020-03-30

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

Conditions

heterozygous familial hypercholesterolemia (HeFH) MedDRA version: 9.0 Level: LLT Classification code 10057099

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: N/A CAS Number: N

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who are 18 to 70 years of age with Heterozygous Familial Hypercholesterolemia and a LDL-C greater than or equal to 100mg/dL and triglycerides less than or equal to 400 mg/dL at Visit 1 while on a stable dose of intensive LDL-C lowering therapy. 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: A condition which, in the opinion of the investigator,might pose a risk to the patient or interfere with participating in the study, patients with 75%) of the carotid artery, chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary or hepatic disease, HIV positive, episode of gout (within 1 year).

Design outcomes

Primary

Measure	Time frame
Main Objective: In patients with heterozygous familial hypercholesterolemia (HeFH): (1) To demonstrate the effects of MK-0524A coadministered with intensive low-density lipoprotein cholesterol (LDL-C) lowering therapy compared to intensive LDL C lowering therapy alone on atherosclerosis progression as measured with non-invasive B-mode ultrasound carotid artery intima medial thickening (cIMT) measurements. ;Secondary Objective: To investigate the efficacy of MK-0524A coadministered with intensive LDL-C lowering therapy compared to intensive LDL-C lowering therapy alone on: (1) lipid profile, as assessed by LDL-C, total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), apolipoprotein (Apo) A-I, Apo B, lipoprotein (a) [Lp(a)], TC/ HDL-C ratio, LDL-C/HDL-C ratio, Apo B/A1 ration, non-HDL-C; (2) high sensitivity C reactive protein (hsCRP); (3) the incidence of CV events, defined as the composite of CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, carotid revascularization, and hospitalization for unstable angina; (4) long-term safety; and (5) relationship between changes in lipoproteins and change in cIMT. ;Primary end point(s): Change from baseline to the end-of-treatment in the ultrasound-determined carotid artery intima medial thickening (cIMT) (measured as the mean-Mean cIMT of the right and left common carotid artery, carotid bulb, and internal carotid arteries on a per subject basis).	—

Measure

Time frame

Main Objective: In patients with heterozygous familial hypercholesterolemia (HeFH): (1) To demonstrate the effects of MK-0524A coadministered with intensive low-density lipoprotein cholesterol (LDL-C) lowering therapy compared to intensive LDL C lowering therapy alone on atherosclerosis progression as measured with non-invasive B-mode ultrasound carotid artery intima medial thickening (cIMT) measurements. ;Secondary Objective: To investigate the efficacy of MK-0524A coadministered with intensive LDL-C lowering therapy compared to intensive LDL-C lowering therapy alone on: (1) lipid profile, as assessed by LDL-C, total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), apolipoprotein (Apo) A-I, Apo B, lipoprotein (a) [Lp(a)], TC/ HDL-C ratio, LDL-C/HDL-C ratio, Apo B/A1 ration, non-HDL-C; (2) high sensitivity C reactive protein (hsCRP); (3) the incidence of CV events, defined as the composite of CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, carotid revascularization, and hospitalization for unstable angina; (4) long-term safety; and (5) relationship between changes in lipoproteins and change in cIMT. ;Primary end point(s): Change from baseline to the end-of-treatment in the ultrasound-determined carotid artery intima medial thickening (cIMT) (measured as the mean-Mean cIMT of the right and left common carotid artery, carotid bulb, and internal carotid arteries on a per subject basis).

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Countries

France, Germany, Sweden, United Kingdom

Outcome results

None listed

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