Effect of an Investigational Compound on Tolerability of Extended Release Niacin (0524A-023)(COMPLETED)

Hyperlipidemia Clinical Trial

Official title:

A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Study to Evaluate the Efficacy of MK0524 to Improve Tolerability of Extended Release Niacin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00376584
• Other study ID #: 0524A-023
• Secondary ID: MK0524A-0232006_
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2006
• Last updated: February 15, 2017
• Start date: July 2006
• Est. completion date: January 2007

Study information

• Verified date: February 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a 12-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the efficacy of MK0524 to improve the tolerability of extended-release niacin. There will be 6 scheduled clinic visits and 3 treatment arms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 825
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patient is appropriate candidate for niacin therapy

• Patients with evidence of ischemic cardiovascular disease must be on a statin and have LDL-C <130 mg/dL at V1

• Patients with diabetes mellitus and no evidence of ischemic cardiovascular disease must have LDL-C <130 mg/dL at V1

• Non-diabetic patients with 2 or more risk factors for coronary heart disease and no ischemic cardiovascular disease must have LDL-C <160 mg/dL at V1

• Patient has TG <500 mg/dL (5.65 mmol/L) at V1

• A patients historic serum or plasma lipid values measured within 6 months from Visit 1 may be used to meet lipid inclusion criteria

• ALL OTHER PATIENTS DO NOT REQUIRE SPECIFIC LIPID ENTRY CRITERIA

Exclusion Criteria:

• Patients with unstable doses of medications

• Pregnant or lactating women, or women intending to become pregnant are excluded

• Patients with diabetes mellitus that is poorly controlled, unstable or newly diagnosed

• Patients with: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, HIV positive, gout (within 1 year)

Related Conditions & MeSH terms

• Hypercholesteremia
• Hypercholesterolemia
• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• MK-0524A

• ER Niacin

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Flushing Severity Score (GFSS) during 7 days of treatment		during 7 days of treatment
Secondary	Percentage of Participants Who Experience at Least 1 Adverse Event		up to 10 weeks
Secondary	Percentage of Participants Who Were Discontinued from the Study Due to an Adverse Event		up to 10 weeks