A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Dose-Ranging Study with Active-Controlled Long-Term Safety Phase to Assess the Efficacy, Safety and Tolerability of MK-6213 in Patients with Primary Hypercholesterolemia orMixed Hyperlipidemia. - Hypercholesterolemia and hyperlipidemia dose ranging study.

• Conditions: Primary hypercholesterolemia or mixed hyperlipidemia; MedDRA version: 9.1Level: LLTClassification code 10020604Term: Hypercholesterolemia

• Registration Number: EUCTR2007-003684-41-BE
• Lead Sponsor: Merck Sharp & Dohme BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-26
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 840

Inclusion Criteria

1.Patient is male or female and 18 to 75 years of age on day of signing informed consent.
2.Patient is (a) female and not of reproductive potential or postmenopausal, or (b) female of reproductive potential who agrees to take acceptable contraceptive precautions for the duration of the study.
3.Patient is classified as low risk” (0-1 risk factors) according to NCEP/ATPIII cardiovascular risk categories and Framingham risk score with an off-treatment LDL-C value of 100-190 mg/dL (2.6–4.9 mmol/L)
-or-
4.Patient is classified as moderate risk” (2 or more risk factors and 10 year CHD risk<10%) according to NCEP/ATPIII cardiovascular risk categories and Framingham risk score with an off-treatment LDL-C value of 100-160 mg/dL (2.6–4.1 mmol/L)
-or-
5.Patient is classified as moderate-high risk” (10-yr CHD risk 10-20%) according to NCEP/ATPIII cardiovascular risk categories and Framingham risk score with
•an off-treatment LDL-C value of 100-145 mg/dL (2.6–3.6 mmol/L)
•or, off-treatment LDL-C 100-130 mg/dL (2.6–3.4 mmol/L) if patient was taking lipid therapy more potent than atorvastatin 10 mg at the time of screening (See Appendix 6.3)
6.Diabetic patients not taking lipid-lowering medication, with LDL-C 100-130 mg/dL (2.6–3.4 mmol/L), who meet all other entry criteria are eligible

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 a history of secondary hypertension (high blood pressure), cardiovascular (heart), renal (kidney), neurologic (nervous system), respiratory (lung), hepatic (liver) or metabolic disease. Patient has a history of mental instability or drug/alcohol abuse within the past 5 years. Patient drinks more than 2 alcoholic drinks per day. Patient is pregnant or nursing. Patient is HIV positive. Patient has a history of cancer within the past 5 years. Patient has been in a investigational trial within the last 30 days

Study & Design

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