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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.

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.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
REPEC
Registry ID
PER-058-02
Enrollment
6
Registered
2002-09-04
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

L-410198 5 mg / day plus simvastatin 10mg Type of group
L-410198 5mg in combination with simvastatin 10mg Group name:simvastatin 10 mg Type of group
Patients will be administered simvastatin 10 mg via oran tablets, then simvastatin 20 mg.

Sponsors

MERCK SHARP & DOHME PERU S.R.L.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

MeasureTime frame
Outcome name:triglycerides Measure:Reductive activity in the triglycerides of L-410198 5mg in combination with simvastatin 10mg compared with that of simvastatin 20mg alone. Timepoints:week 46—

Secondary

MeasureTime frame
Outcome name:triglycerides Measure:Determine the reducing activity in the triglycerides of L-410198 5mg in combination with simvastatin lOmg compared with that of simvastatin 10mg alone. Timepoints:week 46—

Countries

Peru

Contacts

Public ContactStela Lopez

MERCK SHARP & DOHME PERU S.R.L

stela_lopez@merck.com4115935

Outcome results

None listed

Source: REPEC (via WHO ICTRP)