Overview

This trial is active, not recruiting.

Condition hypercholesterolemia
Treatments etc-1002, ezetimibe
Phase phase 2
Sponsor Esperion Therapeutics
Collaborator Medpace, Inc.
Start date September 2013
End date October 2014
Trial size 322 participants
Trial identifier NCT01941836, 1002-008

Summary

The purpose of this research study is to see how ETC-1002 is tolerated in the body, to measure the amount of ETC-1002 in the blood, and to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine in patients with elevated LDL-cholesterol with or without statin intolerance.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Orally, once daily in morning as capsules
etc-1002
Patients receive ETC-1002
(Experimental)
Orally, once daily in morning as capsules
etc-1002
Patients receive ETC-1002
(Active Comparator)
Orally, once daily in morning as capsules
ezetimibe Zetia
Patients receive ezetimibe
(Experimental)
Orally, once daily in morning
etc-1002
Patients receive ETC-1002
ezetimibe Zetia
Patients receive ezetimibe
(Experimental)
Orally, once daily in morning
etc-1002
Patients receive ETC-1002
ezetimibe Zetia
Patients receive ezetimibe

Primary Outcomes

Measure
Percent change in calculated low density lipoprotein-cholesterol (LDL-C)
time frame: Baseline and 12 weeks

Secondary Outcomes

Measure
Percent change in other lipid measures non high density lipoprotein cholesterol (nonHDL-C)
time frame: Baseline and 12 weeks
Safety using adverse event reports; vital signs
time frame: up to 21 weeks including screening
Percent change in Apolipoprotein B (ApoB)
time frame: Baseline and 12 weeks
Percent change in high sensitivity C-reactive protein (hsCRP)
time frame: Baseline and 12 weeks
Safety using adverse event reports; clinical laboratory results
time frame: up to 21 weeks including screening
Safety using adverse event reports; rates of muscle-related adverse
time frame: up to 21 weeks including screening

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Key Inclusion Criteria: - Statin intolerant and statin tolerant - Fasting LDL-C between 130 mg/dL and 220 mg/dL - Fasting triglyceride less than or equal to 400 mg/dL - Body mass index (BMI) between 18 and 45 kg/m2 Key Exclusion Criteria: - History or current clinically significant cardiovascular disease - History or current type 1 diabetes or uncontrolled type 2 diabetes - Use of metformin or thiazolidinediones (TZD) within 3 months of screening - History of joint symptoms difficult to differentiate from myalgia - Uncontrolled hypothyroidism - Liver disease or dysfunction - Renal dysfunction or nephritic syndrome - Gastrointestinal (GI) conditions or prior GI procedures - HIV or AIDS - History or malignancy - History or drug or alcohol abuse within last 2 years - Use of experimental or investigational drugs within 30 days of screening - Use of ETC-1002 in a previous clinical study

Additional Information

Official title A Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients With or Without Statin Intolerance
Description Hypercholesterolemic patients either with or without a history of statin intolerance (1:1 ratio) will be randomized to receive once daily by mouth capsules containing either ETC-1002, ezetimibe, or ETC-1002 + ezetimibe. This study will explore the safety and efficacy of concomitant administration of ETC-1002 and ezetimibe, while also exploring the effect of ezetimibe on ETC-1002 systemic exposure.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Esperion Therapeutics.