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

Phase 3

Completed

• Conditions: Hypercholesteremia; Hyperlipidemia
• Interventions: Drug: MK-0524A; Drug: ER Niacin; Drug: Placebo

• Registration Number: NCT00376584
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-09-14
• Study First Submitted QC: 2006-09-14
• Study First Posted: 2006-09-15
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-15
• Last Update Posted: 2017-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 825

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MK-0524A 2g	MK-0524A	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).
Placebo → MK-0524A 2g	MK-0524A	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).
Placebo → MK-0524A 2g	Placebo	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).
Placebo → Extended Release (ER)-Niacin 2g	Placebo	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)
Placebo → Extended Release (ER)-Niacin 2g	ER Niacin	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)

Primary Outcome Measures

Name	Time	Method
Global Flushing Severity Score (GFSS) during 7 days of treatment	during 7 days of treatment

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Experience at Least 1 Adverse Event	up to 10 weeks
Percentage of Participants Who Were Discontinued from the Study Due to an Adverse Event	up to 10 weeks