Effectiveness of Treatment of Hypercholesterolemia With Rosuvastatin and Ezetimibe

• Status: Completed
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to demonstrate, whether the time of day of administration of the study drug (containing rosuvastatin and ezetimibe) has an impact on the effectiveness of lipid-lowering therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Collegium Medicum w Bydgoszczy
• Treatments: Ezetimibe; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

1. Hypercholesterolemia

2. Ineffectiveness of statin monotherapy in the treatment of hypercholesterolemia after at least 6 weeks

Exclusion Criteria:

1. Active liver disease

2. Unexplained persistent increase in serum transaminase levels, including more than 3 times the upper limit of normal activity of one of them

3. Severe renal impairment (creatinine clearance <30 ml / min)

4. Myopathy

5. Concomitant treatment with cyclosporine, gemfibrozil

6. Pregnancy

7. Lactation

8. Women of childbearing age not using effective methods of contraception

9. Symptoms of muscle damage after using statins or fibrates in the past.

10. The activity of creatine kinase> 5 times the upper limit of normal