Clinical Trials Logo
  1. Home
  2. Hypertriglyceridemia
  3. NCT02859129

Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®) — ECLIPSEIII  

Hypertriglyceridemia Clinical Trial

Official title:
An Open-Label, 2-Cohort Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®), to Assess the Dose Proportionality of Epanova™, and to Compare the Systemic Exposure of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Following Multiple Doses of Epanova™ and Vascepa® in Healthy Normal Subjects

Clinical Trial Summary

This study is intended to evaluate the potential 2-way reciprocal interaction between multiple doses of Epanova™ and a single dose of rosuvastatin

Clinical Trial Description

The PK of rosuvastatin will be monitored following single-dose administration of rosuvastatin with and without multiple-dose administration of 4 g Epanova™ for 13 consecutive days in order to detect a possible interaction between rosuvastatin and Epanova™. The PK of total EPA, total DHA and total EPA+DHA will also be monitored following multiple-dose administration of Epanova™ with and without single-dose administration of 40 mg rosuvastatin. A single dose administration for rosuvastatin has been judged sufficient to yield plasma concentrations that will be detectable with an adequate validated analytical method and characterize adequately the PK of rosuvastatin. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02859129
Study type Interventional
Source AstraZeneca
Contact
Status Completed
Phase Phase 1
Start date September 2013
Completion date November 2013
View Details
See also
  Status Clinical Trial Phase
Completed NCT03929198 - Translation of Pritikin Program to the Community N/A
Completed NCT02250105 - Trial of ARI-3037MO to Reduce Triglyceride Levels in Adults With Severe (≥500 mg/dl) Hypertriglyceridemia Phase 2
Completed NCT01437930 - Intervention With n-3 Polyunsaturated Fatty Acids (PUFA)-Supplemented Products in Moderate Hypertriglyceridemic Patients N/A
Completed NCT01455844 - TRIal For Efficacy of Capre on hyperTriglyceridemiA Phase 2
Completed NCT00959842 - Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia Phase 1/Phase 2
Completed NCT01010399 - Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects Phase 4
Completed NCT00519714 - A Study to Evaluate the Lipid Regulating Effects of 1-Methylnicotinamide (1-MNA) Phase 2/Phase 3
Recruiting NCT00186537 - Comparing Tricor, Avandia, or Weight Loss to Lower Cardiovascular Risk Factors in People With High Triglycerides. N/A
Completed NCT00246402 - Acipimox to Improve Hyperlipidemia and Insulin Sensitivity Associated With HIV N/A
Completed NCT06020950 - Chia Seeds Consumption in Hypertriglyceridemia N/A
Completed NCT02354976 - A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects. Phase 2
Completed NCT04966494 - Impact of Beans and Oats Snack Bar on Hypertriglyceridemic Women N/A
Completed NCT04630366 - A Phase 1, First Time in Humans Study of NST-1024 Phase 1
Completed NCT04650152 - Study to Assess Tricor Therapy Effectiveness in Patients With Metabolic Syndrome (TRISTAN)
Completed NCT03693131 - Efficacy of MND-2119 in Participants With Hypertriglyceridemia Phase 3
Completed NCT04756180 - An Efficacy and Safety Study of Omega-3-acid Ethyl Ester in Chinese Subjects With Hypertriglyceridemia. Phase 3
Completed NCT02868177 - Effect of Totum-63, Active Ingredient of Valedia, on Glucose and Lipid Homeostasis on Subjects With Prediabetes Phase 2/Phase 3
Completed NCT01968720 - Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia Phase 2
Completed NCT01462877 - A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic Phase 4
Completed NCT01211847 - Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia Phase 2