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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
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypercholesteremia Hyperlipidemia Drug: MK-0524A Drug: ER Niacin Drug: Placebo Phase 3

Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
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).
 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)
 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).
 Drug: MK-0524A


Outcome Measures
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Primary Outcome Measures :
  1. Global Flushing Severity Score (GFSS) during 7 days of treatment [ Time Frame: during 7 days of treatment ]

Secondary Outcome Measures :
  1. Percentage of Participants Who Experience at Least 1 Adverse Event [ Time Frame: up to 10 weeks ]
  2. Percentage of Participants Who Were Discontinued from the Study Due to an Adverse Event [ Time Frame: up to 10 weeks ]

Eligibility Criteria
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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
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

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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
Keywords provided by Merck Sharp & Dohme Corp.:
Primary Hypercholesteremia
Mixed Hyperlipidemia
Additional relevant MeSH terms:
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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