None listed
Conditions
Interventions
GROUP 1 Type of group
1) Period I: This group will be treated with MK-0524B 1g / 10mg PO QID every day, Sinvastatin Placebo 3 tablets each one, once a day every day. This regimen will be administered for 4 weeks.
2) Period II: This group will be treated with MK-0524B 2g / 20mg PO QID every day, Sinvastatin Placebo 3 tablets each one, once a day every day. This regimen will be administered until week 12.
Group name:GROUP 7 Type of group
1) Period I: This group will be treated with Sinvastatin 40 mg QID PO, Sinvastatin Placebo 20 mg and 40 mg each once a day every day, MK-0524B Placebo PO QID every day. This regimen will be administered for 4 weeks.
2) Period II: This group will be treated with Sinvastatin 40 mg QID PO, Sinvastatin Placebo 2 tablets once a day every day, MK-0524B Placebo PO BID every day. This regimen will be administered for 4 weeks.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: a) The patient is male or female> 18 and <85 years old. b) A potentially fertile patient agrees to abstain or use (or have her partner use) 2 acceptable methods of birth control during the course of the study. c) The patient has a history of primary hypercholesterolemia or mixed hyperlipidemia. d) The patient has TG <350 mg / dL (3.95 mmol / L) at Visit 2.
Exclusion criteria
Exclusion criteria: a) The patient is pregnant or breastfeeding, or waiting to conceive during the study. b) The patient has a history of malignancy 2.0 mg / dL (177 micromol / L), 2) ALT (SGPT)> 1.5 X ULN, 3) AST (SGOT)> 1.5xULN, 4) CK> 2 X ULN i) The patient is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse. j) The patient has a condition or situation that, in the opinion of the investigator, may put the patient at risk, confuse the results or interfere with their participation in the study. k) The patient is currently dedicated, or plans to dedicate himself during the study, to perform visorose exercise or to an aggressive diet. l) The patient met in 50 mg / day. cc) The patient is currently taking a fibrate. dd) The patient is taking coumarins. ee) The patient is receiving treatment with systemic corticosteroids or systemic anabolic agents. ff) Drugs that are potent inhibitors of CYP3A4. gg) Drugs that increase the risk of myopathy will also be banned. hh) The patient ingests more than 2 alcoholic beverages per day. ii) The patient is a woman who is currently taking hormonal contraceptives or usi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of low density lipoprotein (LDL-c) in peripheral blood. Measure:Percentage change from baseline in LDL-C at week 8 after dose adjustment. Timepoints:Before starting treatment, day 0 and weeks 4 and 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Complete lipid profile: HDL-C, TG, LDL-C ratio: HDL-C, non-HDL-C, Apo B and Apo A-I, TC, Lp (a), TCiHDL, CRP, Apo-Cm and lipid subfractions. Measure:Percent change from baseline in Week 8 of the complete lipid profile. Percent change from baseline in Week 4 of the complete lipid profile. Timepoints:Before starting treatment, day 0 and weeks 4, 8 and 12. ; Outcome name:Physical examination and vital signs. Laboratory tests: Panels of hematology and serum biochemistry. Measure:Safety and tolerability. Timepoints:Physical examination and vital signs: Before starting treatment, day 0 and weeks 4, 8 and 12. Panel of hematology: Before starting the treatment, day 0 and week 12. Serum biochemistry panel: Before starting treatment, day 0 and weeks 4, 8 and 12. | — |
Countries
Andorra, Brazil, Canada, China, Denmark, France, Lithuania, Malasya, Netherlands, Norway, Peru, Poland, Sweden, Taiwan, United Kindgdom, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed