Overview

Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Rosuvastatin

Status:
NOT_YET_RECRUITING

Trial end date:
2025-11-18

Target enrollment:

Participant gender:

Summary

The recommended first-line treatment of cardiovascular disease is a statin monotherapy; however, combination therapies represent an opportunity for an individualized, patient centered approach to lower low density lipoprotein cholesterol (LDL-C) and reduce atherosclerotic cardiovascular disease risk in patients unable to reach individualized serum LDL-C levels. This study will test the bioequivalence of a test fixed dose combination (FDC) vs the co-administration of individual tablets.

Phase:

PHASE1

Details

Lead Sponsor:

Daiichi Sankyo

Treatments:

8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Ezetimibe
Rosuvastatin Calcium