A MULTICENTRIC, DOUBLE-BLIND, RANDOMIZED, ACTIVE STUDY CONTROLLED WITH PARALLEL PLACEBO TO EVALUATE EFFICACY OF LIPID ALTERATION AND SAFETY OF L-410198 IN PATIENTS WITH METABOLIC SYNDROME AND DISLIPIDEMIA TO DETERMINE THE EFFECTS OF LIPID REDUCTION OF L-410198 IN COMBINATION WITH SIMVASTATIN.
- Conditions
- -E785 Hyperlipidaemia, unspecifiedHyperlipidaemia, unspecifiedE785
- Registration Number
- PER-058-02
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Patients can participate in the extension study if: (a) they complete the initial double-blind study and (b) they have met> 75% of the study medication during the double-blind period of the baseline study. Patients who begin the extension study will begin with the study medication the morning after the last visit of the base study period.
Patients who have discontinued the initial study for any reason will not be able to participate in the extension study.
Hypersensitivity or documented myopathy (muscle symptoms and / or CK elevations> 10 times ULN) in simvastatin or another HMG-CoA reductase inhibitor.
AST or ALT of the blood sample in the week before Visit 8 / Week 12> 50% above the Upper Normal Limit (ULN) (ALT> 38 units / L and AST> 33 units / L).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:triglycerides<br>Measure:Reductive activity in the triglycerides of L-410198 5mg in combination with simvastatin 10mg compared with that of simvastatin 20mg alone.<br>Timepoints:week 46<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:triglycerides<br><br><br>Measure:Determine the reducing activity in the triglycerides of L-410198 5mg in combination with simvastatin lOmg compared with that of simvastatin 10mg alone.<br>Timepoints:week 46<br>