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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:	EUCTR
Last refreshed on:	24 April 2012
Main ID:	EUCTR2006-003107-39-DE
Date of registration:	03/07/2006
Prospective Registration:	Yes
Primary sponsor:	Merck & Co
Public title:	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
Scientific title:	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:
Target sample size:	825
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003107-39
Study type:	Interventional clinical trial of medicinal product
Study design:	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
Phase:

Countries of recruitment
Austria	Germany	Italy	United Kingdom

Contacts

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Address:
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Affiliation:

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Key inclusion & exclusion 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 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.

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:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Hypercholesterolemia
MedDRA version: 8.1 Level: LLT Classification code 10020604 Term: Hypercholesterolemia

Intervention(s)

Product Name: MK-0524A (ER-Niacin/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-
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

Primary Outcome(s)

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.

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.

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.
2)To assess the safety and tolerability of MK-0524A.

Secondary Outcome(s)

Secondary ID(s)

0524A-023

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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