Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED)

NCT00384293 | Terminated Phase 3 Results

• 2 other identifiers: 0524A-0412006_506
• Study Type: interventional
• Target: 937
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a 105-week clinical study in patients with heterozygous familial hypercholesterolemia on intensive Low Density Lipoprotein-cholesterol (LDL-C) lowering therapy intended to assess the affects of MK0524A on carotid intima media thickening using ultrasound compared to patients taking placebo. There will be 12 scheduled clinic visits involving review of medical history, physical exam, vital signs, laboratory testing, ultrasound imaging, and electrocardiograms.

Conditions

Hypercholesterolemia, Familial

Outcome Measures

Primary Outcomes (1)

• Change in Mean Carotid Intima Media Thickness

  change in mean carotid intima media thickness defined as a composite measure of the left and right common, bulb, and internal carotid artery.

  after 96 weeks of postrandomization treatment

Secondary Outcomes (1)

• Change in Lipid Profile

  after 96 weeks of postrandomization treatment

Study Arms (2)

1

EXPERIMENTAL

MK0524A

Drug: Comparator: niacin (+) laropiprant (MK0524A)

2

PLACEBO COMPARATOR

placebo

Drug: Comparator: placebo

Interventions

Comparator: niacin (+) laropiprant (MK0524A) DRUG

niacin (+) laropiprant (2 g) po qd.

Also known as: MK0524A

1

Comparator: placebo DRUG

niacin (+) laropiprant (2 g) placebo po qd.

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 400mg/dL at Visit 1 while on a stable dose of intensive LDL-C lowering therapy

You may not qualify if:

• 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 less than 80% drug study compliance
• Patients with chronic medical conditions known to influence serum lipids or lipoproteins or significantly affect the ultrasound acoustic window
• Patients with unstable dose of medications
• Pregnant or lactating women, or women intending to become pregnant are excluded
• Patient with diabetes mellitus that is poorly controlled, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)
• Patients with the following conditions: high grade stenosis (greater than 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

MK-0524

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

After a detailed review of pooled carotid IMT data from contemporary studies, the Steering Committee recommended that Merck prematurely stop the study; as designed, the study was significantly underpowered. Efficacy analyses were not performed.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2006
• First Posted: October 6, 2006
• Study Start: September 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: September 30, 2015
• Results First Posted: September 2, 2009

Record last verified: 2015-09