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MULTICENTRIC STUDY DOUBLE BLIND, RANDOMIZED, PARALLEL, CONTROLLED WITH PLACEBO AND ACTIVE CONTROLLER TO EVALUATE THE EFFECTIVENESS AND SAFETY OF L-410198 IN THE ALTERATION OF LIPIDS IN PATIENTS THAT SUFFER FROM METABOLIC SYNDROME AND DYSLIPIDEMIAS

MULTICENTRIC STUDY DOUBLE BLIND, RANDOMIZED, PARALLEL, CONTROLLED WITH PLACEBO AND ACTIVE CONTROLLER TO EVALUATE THE EFFECTIVENESS AND SAFETY OF L-410198 IN THE ALTERATION OF LIPIDS IN PATIENTS THAT SUFFER FROM METABOLIC SYNDROME AND DYSLIPIDEMIAS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-020-02
Enrollment
30
Registered
2002-02-28
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

placebo Type of group
The patient will take the placebo in the morning a once a day as directed by the study doctor. Patients will be advised to continue with the diet and exercise regimen. Group name:200 mg fenofibrate Type of group
200 mg fenofibrate will be given in the morning once a day as directed by the study doctor. Patients will be advised to continue with the diet and exercise regimen during the simple blind transition period.

Sponsors

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

Eligibility

Inclusion criteria

Inclusion criteria: * Between 21 and 65 years of age, inclusive. * Fasting triglyceride levels of> 180 mg / dL (> 2.0 mmol / L), but <600 mg / dL (<6.8 mmol / L). * Have at least 2 of the following additional Metabolic Syndrome criteria (as defined by NCEP)

Exclusion criteria

Exclusion criteria: It excludes participation in the study of those individuals who fail to comply with one of the criteria of the visit 1

Design outcomes

Primary

MeasureTime frame
Outcome name:All analytes evaluated after the standard dinner and remain fasted for 12 hours: 1) Lipid metabolism: Routine lipid profile (total cholesterol, LDL-C, HDL-C, non-HDL-C, triglycerides): Visits 1,2,4 and fasting blood sample 7 days before the visit 8). Lipid profile with analysis based on ultracentrifugation including LDL-C, VLDL-C, VLDL-TG: Visits 3, 6, 8. Apolipoproteins AI, AII, CIII, B, and free fatty acids: Visits 3 and 8. (2) Glucose metabolism: Selected visits: GPA, HbA1c, C-peptide, insulin; Visits 3 and 8: OGTT (75 grams) with insulin, C peptide, and glucose afterload. Measure:Efficacy in the reduction of triglycerides and the dose range of L-410198 in patients with metabolic syndrome-dyslipidemia. Timepoints:It will be measured in weeks 2, 4, 6, 8, 12 and a follow-up visit in Week 14.—

Secondary

MeasureTime frame
Outcome name:Lipid metabolism: Routine lipid profile (total cholesterol, LDL-C, HDL-C, non-HDL-C, triglycerides): Visits 1,2,4 and fasting blood sample 7 days before Visit 8) . Measure:Efficacy in the elevation of high density lipids (HDL) and the dose range of L-410198 Timepoints:It will be measured in weeks 2, 4, 6, 8, 12 and a follow-up visit in Week 14.—

Countries

Peru, United States

Contacts

Public ContactStela Lopez

MERCK SHARP & DOHME PERU S.R.L

stela_lopez@merck.com4115935

Outcome results

None listed

Source: REPEC (via WHO ICTRP)