None listed
Conditions
Interventions
Group 1 Type of group
MK-0524B 1g / 10mg at 2g / 20mg for 12 weeks co-administered with MK0524A and simvastatin
Group name:Group 6 Type of group
Atorvastatin 10 mg orally for 12 weeks
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • The patient is male or female> 18 and 150 mg / dL to <500 mg / dL (1.7 - 5.6 mmol / L) at Visit 2.
Exclusion criteria
Exclusion criteria: • The patient is pregnant or breastfeeding, or expecting to conceive during the study, including the 14-day follow-up period after the study. • The patient has a history of malignancy 300 mL within 8 weeks prior to signing the informed consent, intended to give or receive blood products during the study, aims to donate more than 250 mL of blood products within 8 weeks after the last study visit. • The patient has the following laboratory values ​​excluding in Visit 1: Creatinine> 2.0 mg / dL (177 micromol / L), ALT (SGPT)> 1.5xULN, AST (SG0T)> 1.5xULN, CK> 2xULN, abnormal TSH • The patient has Type 1 or Type 2 diabetes mellitus • The patient is, at the time of signing the informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse. • The patient is currently involved, or plans to be involved during the study, in vigorous exercise or an aggressive diet regimen. (See Appendix 6 and Section I.E.4.e) for guidelines and recommendations regarding exercise and diet). • The patient met 160 mm Hg or diastolic pressure> 100 mm Hg) at Visit 1. Researchers are encouraged to maximize control of blood pressure in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:It is defined as the average of the measurements of Week-1 and Day 1 (randomization visit). If the value of the Week is missing - Day 1, the last available value will be used as baseline. Measure:Percentage change from baseline in the LDL-C / HDL-C ratio at the endpoint of the study Timepoints:16 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The percentage change with respect to the baseline for these parameters are defined similarly to those corresponding to the LDLC / HDL-C ratio. Measure:Percentage change with respect to the baseline at the endpoint of the study in: HDL-C, TG, non-HDL-C, LDL-C Timepoints:16 weeks ; Outcome name:Safety will be assessed by clinical and / or statistical review of all safety parameters, including adverse events (AE), laboratory values and vital signs throughout the treatment period. Measure:Safety Timepoints:16 weeks | — |
Countries
Chile, Colombia, Lithuania, Peru, Poland, Spain, Switzerland, United Kindgdom, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed