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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Hyperlipidemia; Hypercholesteremia

Treatments: Drug: ER Niacin; Drug: MK-0524A; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00376584

2006_504

MK0524A-023

0524A-023

Details and patient eligibility

About

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.

Enrollment: 825 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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825 participants in 3 patient groups, including a placebo group

Placebo → MK-0524A 2g

Placebo Comparator group

Description:

Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A Placebo for 5 days (drug holiday) followed by MK-0524A 2 g for the remainder of the study (7 days).

Treatment:

Drug: MK-0524A

Drug: Placebo

Placebo → Extended Release (ER)-Niacin 2g

Active Comparator group

Description:

Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A Placebo for 5 days (drug holiday) followed by ER-Niacin 2g for the remainder of the study (7 days)

Treatment:

Drug: Placebo

Drug: ER Niacin

MK-0524A 2g

Experimental group

Description:

Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A 2g for the remainder of the study (approximately 2 weeks).

Treatment:

Drug: MK-0524A