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EVALUATION OF THE EFFICACY AND SAFETY OF THE CO-ADMINISTRATION OF PHENOFIBRATE AND EZETIMIBE IN PATIENTS WITH MIXED HYPERLIPIDEMIA - GENOMIC AMENDMENT

EVALUATION OF THE EFFICACY AND SAFETY OF THE CO-ADMINISTRATION OF PHENOFIBRATE AND EZETIMIBE IN PATIENTS WITH MIXED HYPERLIPIDEMIA - GENOMIC AMENDMENT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-064-02
Enrollment
16
Registered
2002-10-28
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

Fenofibrate / Ezetimibe Type of group
You will be given 160 mg / day of fenofibrate and 10 mg / day of ezetimibe. Group name:Placebo Type of group
fenofibrate and ezetimibe placebo will be administered.

Sponsors

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

Eligibility

Inclusion criteria

Inclusion criteria: If they are adults between 18 and 75 years of age. Men, women in post-menopausal stage or women in premenopausal age: both sterilized surgically and with high probabilities of not conceiving, and with a negative pregnancy test in Visit 1.

Exclusion criteria

Exclusion criteria: a. Chronic cardiac dysfunction NYHA Classes m or IV. b. Cardiac arrhythmias not controllable. c. History of CHD disease or equivalent to CHD (except diabetes mellitus), or a risk of developing CHD> 20%, as established by the NCEP ATP Ht criteria (see Appendix 7 for definitions). d. History of pancreatitis. e. Unstable hypertension (systolic pressure> 160 mm Hg or diastolic pressure> 100 mm Hg) at Visit 1. f. Disorders of the haematological, digestive, or central nervous system including the degenerative disease that would limit the evaluation or participation in the study.

Design outcomes

Primary

MeasureTime frame
Outcome name:LDL-C Measure:Reductive efficacy in the low density lipoprotein cholesterol of the co-administration of 160 mg / day of fenofibrate and 10 mg / day of ezetimibe compared to the monotherapy of 160 mg / day of fenofibrate. Timepoints:12 week—

Secondary

MeasureTime frame
Outcome name:Clinical evaluation (physical examination, vital signs); adverse events; laboratory tests-ALT, AST, CK, TG, serum creatinine and any other laboratory evaluation of general control (hematology, chemistry, urinalysis, B-hCG). Measure:Safety and tolerance of the co-administration of 160 mg / day of fenofibrate and 10 mg / day of ezetimibe. Timepoints:12 week—

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)