Effect of an Investigational Compound on Tolerability of Extended Release Niacin (0524A-023)(COMPLETED)
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ClinicalTrials.gov Identifier: NCT00376584 |
Recruitment Status :
Completed
First Posted : September 15, 2006
Last Update Posted : February 16, 2017
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Condition or disease | Intervention/treatment | Phase |
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Hypercholesteremia Hyperlipidemia | Drug: MK-0524A Drug: ER Niacin Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 825 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Study to Evaluate the Efficacy of MK0524 to Improve Tolerability of Extended Release Niacin |
Study Start Date : | July 2006 |
Actual Primary Completion Date : | January 2007 |
Actual Study Completion Date : | January 2007 |

Arm | Intervention/treatment |
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Placebo Comparator: Placebo → MK-0524A 2g
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).
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Drug: MK-0524A Drug: Placebo |
Active Comparator: Placebo → Extended Release (ER)-Niacin 2g
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)
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Drug: ER Niacin Drug: Placebo |
Experimental: MK-0524A 2g
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).
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Drug: MK-0524A |
- Global Flushing Severity Score (GFSS) during 7 days of treatment [ Time Frame: during 7 days of treatment ]
- Percentage of Participants Who Experience at Least 1 Adverse Event [ Time Frame: up to 10 weeks ]
- Percentage of Participants Who Were Discontinued from the Study Due to an Adverse Event [ Time Frame: up to 10 weeks ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376584
Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00376584 |
Other Study ID Numbers: |
0524A-023 MK0524A-023 2006_504 |
First Posted: | September 15, 2006 Key Record Dates |
Last Update Posted: | February 16, 2017 |
Last Verified: | February 2017 |
Primary Hypercholesteremia Mixed Hyperlipidemia |
Hyperlipidemias Hyperlipoproteinemias Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Niacin Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vasodilator Agents Vitamin B Complex Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs |