A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate /Simvastatin 145/20mg and Fenofibrate / Simvastatin 145/40mg Tablets versus Fenofibrate or Simvastatin Monotherapies in Subjects with Abnormal Levels of Fats(lipids) in the Blood and at High Risk of Cardiovascular Disease.
- Registry ID
- EUCTR2011-005924-16
- Source registry
- EUCTR
- Status
- Completed
- Phase
- PHASE3
- Sponsor
- Abbott Laboratories Ireland Limited
- Start date
- 2012-06-13
- Completion date
- 2014-01-28
- Last update
- 2026-08-16
Conditions
Summary
To compare the efficacy of the two fixed-combinations (FC) - fenofibrate/simvastatin 145/20 mg tablet and fenofibrate/simvastatin 145/40 mg tablet in reducing triglycerides (TG) and increasing high density lipoprotein cholesterol (HDL-C) versus simvastatin 20 mg or 40 mg, and in reducing low density lipoprotein cholesterol LDL-C versus fenofibrate 145 mg in subjects with mixed dyslipidemia (type IIb) at high or very high risk of cardiovascular disease after 12 weeks of treatment.
Locations
Related clinical trials
- A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors
- Kodo Millet Porridge and Its Effects on Gut Health and Metabolic Syndrome
- A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated Lipoprotein (a) (Lp[a]) Levels, and Participants With Dyslipidemia
- Taiwan Green Propolis for Blood Lipids and Body Fat in Patients With MASLD
- A Randomized, Open-label, Two-arm, Two-period, Multiple-dose, Study to Evaluate Pharmacokinetic Drug-drug Interaction, Safety and Tolerability of UIC202601 and UIC202602 in Healthy Volunteers
- Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD
View on source registry