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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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30 June 2019 |
Main ID: |
EUCTR2006-003107-39-GB |
Date of registration:
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09/08/2006 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Worldwide, Multicenter, Double-Blind, Randomized, Parallel Study to Evaluate the Efficacy of MK-0524 to Improve Tolerability of Extended Release Niacin - Effect of an Investigational Compound on Tolerability of Extended Release Niacin
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Scientific title:
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A Worldwide, Multicenter, Double-Blind, Randomized, Parallel Study to Evaluate the Efficacy of MK-0524 to Improve Tolerability of Extended Release Niacin - Effect of an Investigational Compound on Tolerability of Extended Release Niacin |
Date of first enrolment:
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25/08/2006 |
Target sample size:
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825 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003107-39 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Germany
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Italy
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria: Patient is male or female, aged 18 to 70 years. Female patients of reproductive potential agree to be abstinent or to use 2 acceptable methods of birth control for duration of study. Acceptable defined as IUD, diaphragm with spermicide, contraceptive sponge, condom, vasectomy. 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 patient’s 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. Glycemic status of patient has been determined prior to visit 2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: Patients with unstable doses of medications. Pregnant or lactating women, or women intending to become pregannt are excluded. Patients with diabetes mellitus that is poorly controlled, newly diagnosed, has recently experienced repeated hypoglycemia or unstable glycemic control, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin). Patients with the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, HIV positive, gout (within 1 year).
Age minimum:
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Hypercholesterolemia
MedDRA version: 8.1
Level: LLT
Classification code 10020604
Term: Hypercholesterolemia
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Intervention(s)
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Product Name: MK-0524A (ER-Niacin/MK-0524) Pharmaceutical Form: Tablet INN or Proposed INN: Nicotinic Acid CAS Number: 59-67-6 Current Sponsor code: N/A Other descriptive name: ER-Niacin or Niacin Concentration unit: g gram(s) Concentration type: equal Concentration number: 1- INN or Proposed INN: MK-0524 or L-000888839-000E CAS Number: N/A Current Sponsor code: N/A Other descriptive name: N/A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Product Name: MK-0524A (1g ER-Niacin/Placebo MK-0524) Product Code: N/A Pharmaceutical Form: Tablet INN or Proposed INN: Nicotinic Acid CAS Number: 59-67-6 Current Sponsor code: N/A Other descriptive name: ER-Niacin or Niacin Concentration unit: g gram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): The primary endpoint of maximum GFSS categorized into none/mild, moderate, severe, extreme during the first 7 days following a 5 day drug holiday period will be compared between the MK-0524A/Placebo/MK-0524A treatment group and the MK-0524A/Placebo/ER-Niacin group using the Cochran-Mantel-Haenszel (CMH) test stratified by country.
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Main Objective: To demonstrate the efficacy of MK-0524 to protect against niacin-induced flushing in patients who resume therapy with either MK-0524A 2g or ER-niacin 2g after a 5 day drug holiday from a stable dose of MK-0524A 2g. MK 0524A will produce less flushing that ER-niacin as measured by maximum Global Flushing Severity Score (GFSS) categorised into none/mild, moderate, severe, extreme during the first 7 days following a 5-day holiday.
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Secondary Objective: 1)To demonstrate the efficacy of MK-0524 to protect against niacin-induced flushing in patients who resume therapy with either MK-0524A 2g or ER-niacin 2g after a 5 day drug holiday from a stable dose of MK-0524A 2g MK 0524A will produce less flushing that ER-niacin as measured by: a. maximum GFSS during the first 7 days following a 5-day drug holiday b. the percentage of patients with moderate or greaster GFSS(>4) during the first 7 days following a 5-day drug holiday. c. the percentage of patients with moderate or severe GFSS (>7) during the first 7 days following a 5-day drug holiday.
2)To assess the safety and tolerability of MK-0524A.
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Secondary ID(s)
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0524A-023
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2006-003107-39-DE
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
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