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A Randomized Study to Evaluate the Efficacy and Safety of Bempedoic Acid 180 + Ezetimibe 10 Fixed-Dose Combination Compared to Ezetimibe and Placebo In Subjects With T2DM and Elevated LDL-Cholesterol
12 week study to assess the LDL-C lowering efficacy, other lipid and glycemic measures, and safety of bempedoic acid/ezetimibe FDC compared to ezetimibe and placebo in patients with type 2 diabetes (T2D) and elevated LDL-C
Assess efficacy of FDC vs. ezetimibe vs. placebo for 12 week LDL-C lowering, changes in atherogenic lipids, hsCRP and exploratory glycemic measures as well as safety in patients with type 2 diabetes and elevated LDL-C.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Clinical Trials Research
Lincoln, California, United States
FInlay Medical Research
Miami, Florida, United States
L-MARC Research Center
Louisville, Kentucky, United States
Hampton Roads Center for Clinical Research
Suffolk, Virginia, United States
Start Date
May 9, 2018
Primary Completion Date
June 18, 2019
Completion Date
June 18, 2019
Last Updated
April 9, 2020
242
ACTUAL participants
Bempedoic acid + Ezetimibe FDC Oral Tablet
DRUG
Ezetimibe 10 mg Oral Tablet
DRUG
Placebo Oral Tablet
DRUG
Placebo oral capsule
DRUG
Lead Sponsor
Esperion Therapeutics, Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07296484