Ezetimibe-Simvastatin Evaluation Study
Nyckelord
Abstrakt
Beskrivning
The additional study objectives are:
1. To evaluate the efficacy of a fixed combination of ezetimibe-simvastatin in patients with hypercholesterolemia to improve the lipid profile (HDL-C ↑, T-CHOL, Triglycerides ↓).
2. Evaluation of the response of patients with hypercholesterolemia who received a fixed combination of ezetimibe-simvastatin to achieve a target according to the category of total cardiovascular risk to which they belong.
3. To evaluate the efficacy of a stable combination of ezetimibe and simvastatin in patients with hypercholesterolemia in improving non-HDL-cholesterol (non-HDL-C) levels.
4. Safety assessment through the recording of Adverse Events during the study.
Datum
| Senast verifierad: | 06/30/2020 |
| Först skickat: | 05/09/2019 |
| Beräknad anmälan inlämnad: | 05/09/2019 |
| Först publicerad: | 05/12/2019 |
| Senaste uppdatering skickad: | 07/20/2020 |
| Senaste uppdatering publicerad: | 07/21/2020 |
| Faktiskt startdatum för studien: | 08/31/2020 |
| Uppskattat primärt slutdatum: | 09/29/2021 |
| Beräknat slutfört datum: | 09/29/2021 |
Tillstånd eller sjukdom
Fas
Urvalskriterier
| Åldrar berättigade till studier | 18 Years Till 18 Years |
| Kön som är berättigade till studier | All |
| Testmetod | Non-Probability Sample |
| Accepterar friska volontärer | Ja |
| Kriterier | Inclusion Criteria: - Patients diagnosed with primary (heterozygous familial and non-familial) hypercholesterolemia, homozygous familial hypercholesterolemia or mixed hyperlipidemia. - Patients not properly responded with a statin only. - Patients who have not achieved LDL-C with previous treatment. - Adult patients who will sign their consent form to participate in the study. Exclusion Criteria: - Patients who have not fully understood the study procedures and have not signed the consent form. - Hypersensitivity to the active substances or to any of the excipients of study drug. - Pregnancy and breastfeeding. - Active liver disease or unexplained persistent increases in serum transaminases. - Concomitant administration of potent inhibitors of the CYP3A4 system (agents that increase the AUC approximately 5 times or more) (eg, itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors (eg nelfinavir ), boceprevir, telaprevir, nefazodone and combesistate containing medicines. - Concomitant administration of gemfibrozil, cyclosporine or danazol. - Patients with homozygous familial hypercholesterolaemia (HoFH), concurrent administration of lopithipid with doses of study drug> 10 mg / 40 mg. |
Resultat
Primära resultatåtgärder
1. LDL-C [3 months]
Sekundära resultatåtgärder
1. Lipidemic profile [3 months]
2. Cardiovascular risk factor [3 months]
3. Adverse Events [3 months]
