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MULTICENTRIC, DOUBLE-BLIND, FACTORIAL STUDY CONTROLLED WITH PLACEBO AND RANDOMIZED TO EVALUATE EFFICACY AND SAFETY IN THE ALTERATION OF LIPIDS OF THE EZETIMIBE / SIMVASTATIN MIXED TABLET IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA

MULTICENTRIC, DOUBLE-BLIND, FACTORIAL STUDY CONTROLLED WITH PLACEBO AND RANDOMIZED TO EVALUATE EFFICACY AND SAFETY IN THE ALTERATION OF LIPIDS OF THE EZETIMIBE / SIMVASTATIN MIXED TABLET IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-059-02
Enrollment
20
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

Ezetimibe Type of group
Ezetimibe will be supplied in 10 mg tablets simvastatin tablets of 10, 20, 40 and 80 mg Group name:Ezetimibe Type of group
Ezetimibe will be supplied in 10 mg tablets

Sponsors

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

Eligibility

Inclusion criteria

Inclusion criteria: a. Men or women> 18 and <80 years of age. b. People willing to make a regimen of Therapeutic Changes of Lifestyle (TLC) of the NCEP or a similar diet of cholesterol reduction during the course of the study.

Exclusion criteria

Exclusion criteria: a. Weight 14 drinks per week. e. Pregnant women or breastfeeding

Design outcomes

Primary

MeasureTime frame
Outcome name:LDL-C Measure:efficacy in the reduction of low lipoprotein cholesterol in patients with primary hypercholesterolemia. Timepoints:12 weeks—

Secondary

MeasureTime frame
Outcome name:physical examination, vital signs, electrocardiogram and interviews with patients. Laboratory evaluations: serum alanine aminotransferase, serum aspartate aminotransferase, and creatine phosphokinase. Measure:To assess the safety and tolerability of the combination tablet of ezetimibe / simvastatin. Timepoints:12 weeks—

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)