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

Not Applicable

• Conditions: -E78 Disorders of lipoprotein metabolism and other lipidaemias; Disorders of lipoprotein metabolism and other lipidaemias; E78

• Registration Number: PER-064-02
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-10-28
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified