A Multicenter, Randomized, Double-Blind, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of MK-0524B (dosed as coadministered MK-0524A and Simvastatin Tablets) Versus Atorvastatin in Patients With Mixed Hyperlipidemia - MK-0524B Atorvastatin Comparator

Phase 1

• Conditions: Mixed Hyperlipidemia; MedDRA version: 9.1 Level: LLT Classification code 10027763 Term: Mixed hyperlipidemia

• Registration Number: EUCTR2007-000037-19-GB
• Lead Sponsor: Merck & Co Inc.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-13
• Study Completion: 2010-08-06
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 2335

Inclusion Criteria

Patient is male or female =18 and = 80 years of age on day of signing informed consent.
Contaception for female patients who are of reproductive potential: agree to remain abstinent or use (or partner use) 2 acceptable methods of birth control for duration of study
Patient meets one of the following criteria (based on NCEP ATP III categorization of CHD risk) at Visit 2 :
Following Washout of Previous Lipid-Lowering Therapy
Multiple Risk
Patient has been washed out of a statin or other lipid-modifying therapy and has multiple risk factors (=2 RF) with an LDL-C =130 mg/dL and =160 mg/dL (3.4 and 4.1 mmol/L).
Low Risk
Patient has been washed off of a statin or other lipid-modifying therapy and is low risk (0-1 RF) with an LDL-C =130 mg/dL and =190 mg/dL (3.4 and 5.0 mmol/L).
Naïve patients (not currently on lipid-lowering therapy)
High Risk
Patient is not on a statin or other lipid-modifying therapy and is high risk (CHD/CHD risk equivalent including diabetes) with an LDL-C =130 mg/dL and =160 mg/dL (3.4 and 4.1 mmol/L).
Multiple Risk
Patient is not on a statin or other lipid-modifying therapy and has multiple risk factors (=2 RF) with an LDL-C =130 mg/dL and =160 mg/dL (3.4 and 4.1 mmol/L).
Low Risk
Patient is not on a statin or other lipid-modifying therapy and is low risk (0-1 RF) an LDL-C =130 mg/dL and =190 mg/dL (3.4 and 5.0 mmol/L).

Triglycerides (TG) concentrations =150 mg/dL to =500 mg/dL (1.7 - 5.6 mmol/L) at 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

Patient has the following exclusionary laboratory values at Visit 1:
•Creatinine >2.0 mg/dL (177 micromol/L)
•ALT (SGPT) >1.5 x ULN
•AST (SGOT) >1.5 x ULN
•CK >2 x ULN
•Abnormal TSH

Patient with Type 1 or Type 2 diabetes mellitus and:
•is poorly controlled (HbA1C at Screening >8%)
•is newly diagnosed (within 3 months of Visit 1)
•is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of ± 10 units of insulin) within 3 months of Visit 2.
•is taking lipid altering therapy which would require washout prior to study participation.

Patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e., secondary causes of hyperlipidemia, such as hypothyroidism or hyperthyroidism).

Patient has (as specified in the protocol): nephrotic syndrome or clinically significant renal disease, chronic heart failure, active peptic ulcer or episode of gout within 1 year of Visit 1

Patient has a history of hypersensitivity or allergic reaction to niacin or niacin-containing products, simvastatin, or atorvastatin. Patient has history of myocardial infarction, stroke, coronary artery bypass surgery or other revascularization procedure, unstable angina or angioplasty within 3 months of Visit 1.

Patient has (as specified in the protocol): uncontrolled/unstable cardiac arrhythmias/hypertension, MI, stroke, coronary bypass. Ileal/gastric bypass, chronic hepatic disease, or is HIV positive

Prohibited concomitant therapies (as specified in the protocol): patient is on
potent inhibitors of CYP3A4, niacin more than 50mg/day, orlistat, sibutramine, or other anti-obesity medication, systemic corticosteroids

Patient is on lipid-modifying agents including fish oils >500 mg, bile-acid sequestrants, HMG-CoA reductase inhibitors, ezetimibe, ezetimibe/simvastatin, Cholestin™ and other red rice yeast products within 6 weeks and fibrates within 8 weeks prior to Visit 2. Patients are eligible for participation in this study ONLY after the prespecified washout period as indicated.

Patient is a woman currently taking hormonal contraceptives or intermittent use of HRTs (e.g., estradiol, medroxyprogesterone, progesterone).

Patient is taking the following antioxidant vitamins:
Vitamin C in excess of 1500 mg/day
Vitamin E in excess of 45 IU/day for men, 36 IU for women
Beta Carotene 15000 IU for men 12000 IU/day for women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified