A Multicenter, Randomized, Double-Blind, "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of MK-0524B Combination Tablet in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia - Factorial Study

• Register: EUCTR
• Last refreshed on: 18 April 2012
• Main ID: EUCTR2005-005094-30-LT
• Date of registration: 02/12/2005
• Prospective Registration: Yes
• Primary sponsor: Merck & Co., Inc
• Public title: A Multicenter, Randomized, Double-Blind, "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of MK-0524B Combination Tablet in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia - Factorial Study
• Scientific title: A Multicenter, Randomized, Double-Blind, "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of MK-0524B Combination Tablet in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia - Factorial Study
• Date of first enrolment: 04/01/2006
• Target sample size: 1400
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005094-30
• 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: no Placebo: no Other: yes Other specify the comparator: Components: simvastatin and/or MK-0524A

Countries of recruitment

Denmark, Lithuania, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Patients 18 to 85 years of age with primary hypercholesterolemia or mixed hyperlipidemia with LDL-C between 130 and 190 mg/L (Category I) and 130 and 160 mg/L (Catetory II) and triglycerides = 350 mg/dL.
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:
A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study, patients with <80% compliance, patients with certain medical conditions including those with a history of CHD/CHD equivalent or diabetes, patients taking certain concomitant medications and/or with unstable doses of medications.


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

Health Condition(s) or Problem(s) studied

Hypercholesterolaemia
MedDRA version: 8.0 Level: LLT Classification code 10020603

Intervention(s)

Product Name: MK-0524A (ER-Niacin/MK-0524) 1g/20mg Tablets; MK-0524A
Product Code: MK-0524A (ER-Niacin/MK-0524) 1g/20mg or MK-0524A
Pharmaceutical Form: Tablet
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: MK-0524 or L-000888839-000E
Other descriptive name: N/A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: Nicotinic Acid
CAS Number: 59-67-6
Current Sponsor code: Niacin or ER-Niacin
Other descriptive name: N/A
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

Product Name: MK-0524B (ER-Niacin/MK-0524/Simvastatin)
Product Code: MK-0524B (ER-Niacin/MK-0524/Simvastatin)
Pharmaceutical Form: Tablet
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: MK-0524 or L-000888839-000E
Other descriptive name: N/A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: Nicotinic Acid
CAS Number: 59-67-6
Current Sponsor code: Niacin or ER-Niacin
Other descriptive name: N/A
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: Simvastatin
Current Sponsor code: ZOCOR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10, 20, 40-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: ZOCOR
Product Name: Simvastatin, ZOCOR
Product Code: Simvastatin, ZOCOR
Pharmaceutical Form: Tablet
INN or Proposed INN: Simvastatin
Current Sponsor code: ZOCOR or Simvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10, 20, 40-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: In patients with primary hypercholesterolemia or mixed hyperlipidemia, evaluate:
The effects of MK-0524B 2g (pooled across simvastatin doses of 20 and 40 mg) compared to simvastatin (pooled across doses of 20 and 40 mg) on HDL-C, TG, LDL-C, LDL-C:HDL-C ratio, non-HDL-C, Apo B, and Apo A-I.
The effects of MK-0524B 2g (pooled across simvastatin doses of 20 and 40 mg) compared to MK-0524A 2g on HDL-C, TG, LDL-C:HDL-C ratio, non-HDL-C, Apo B, and Apo A-I.
Safety and tolerability of MK-0524B
Other secondary objectives:
In patients with primary hypercholesterolemia or mixed hyperlipidemia, evaluate:
Assess the effects of MK-0524B on TC, Lp(a), TC:HDL ratio, RLP-C, CRP, Apo C-III, VLDL-C, and lipid subfractions.

Main Objective: In patients with primary hypercholesterolemia or mixed hyperlipidemia, evaluate:
The LDL-C lowering efficacy of MK-0524B 2g (pooled across simvastatin doses of 20 and 40 mg) compared to MK-0524A 2g.

Primary end point(s): In patients with primary hypercholesterolemia or mixed hyperlipidemia MK-0524B 2g (pooled across simvastatin doses of 20 and 40 mg) will produce greater reductions in LDL-C than MK-0524A 2g.

Secondary ID(s)

0524B-022