AMulticenter, Randomized, Double-Blind, Placebo-and Active-Controlled Study to Assess the Efficacy and Tolerability of MK-6213 Co-Administered with Atorvastatin in Patients with Primary Hypercholesterolemia
- Conditions
- Primary hypercholesterolemiaMedDRA version: 9.1Level: LLTClassification code 10020604Term: Hypercholesterolemia
- Registration Number
- EUCTR2007-003684-41-DE
- Lead Sponsor
- Merck & Co., Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 330
1.Patient is male or female and 18 to 75 years of age on day of signing informed consent.
2.A female patient who is not of reproductive potential without requiring the use of contraception. A female patient who is not of reproductive potential is defined as: one who has either 1) reached naturalmenopause (defined as 6 months of spontaneous amenorrhea with serum FSH levels in the postmenopausal range as determined bythe laboratory, or 12 months of spontaneous amenorrhea), 2) 6 weeks post surgical bilateral oophorectomywith or without hysterectomy, or 3) bilateral tubal ligation.
3. A female of reproductive potential who agrees to take acceptable contraceptive precautions for the duration of the study.
Examples of acceptable contraception may include:
• abstinence
• use of 2 methods of birth control for the duration of the study including intrauterine device (IUD), diaphragm with spermicide, cervical cap, vaginal sponge, condom
• vasectomy (male partner)
• exclusive homosexual relationship
Note: A successful vasectomyis defined as: (a) microscopic documentation of azoospermia, or (b) greater than 2 yearsago with no resultant pregnancydespite sexual activitypost vasectomy
4.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-
5.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-
6.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)
7.Diabetic patients NOTtaking lipid-lowering medication, with LDL-C 100-130 mg/dL (2.6–3.4 mmol/L),with<2 other cardiovascular risk factors, and without microalbuminuria who meet all other entrycriteria are eligible (see Section 2.3 Patient Exclusion Criteria (h).
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
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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method