Evaluation of ETC-1002 in Patients With Hypercholesterolemia and Hypertension

Sponsor

Esperion Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02178098

Collaborator

Medpace, Inc. (Industry)

143

Enrollment

Locations

Arms

Duration (Months)

4.1

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Phase 2 study will assess the efficacy and safety of ETC-1002 monotherapy versus placebo in patients with hypercholesterolemia and hypertension.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia Hypertension	Drug: ETC-1002 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

143 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Placebo-Controlled, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of ETC-1002 in Patients With Hypercholesterolemia and Hypertension

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ETC-1002 ETC-1002 180 mg/day	Drug: ETC-1002 ETC-1002 capsules taken once daily
Placebo Comparator: Placebo Placebo control	Drug: Placebo Placebo capsules taken once daily

Arm

Intervention/Treatment

Experimental: ETC-1002

ETC-1002 180 mg/day

Drug: ETC-1002

ETC-1002 capsules taken once daily

Placebo Comparator: Placebo

Placebo control

Drug: Placebo

Placebo capsules taken once daily

Outcome Measures

Primary Outcome Measures

Percent change in calculated LDL-cholesterol (LDL-C) [Baseline to week 6]

Secondary Outcome Measures

Change in 24-hour, day-time and night-time mean systolic blood pressure [Baseline to week 6]
Change in 24-hour, day-time and night-time mean diastolic blood pressure [Baseline to week 6]
Percent change in high-sensitivity C-reactive protein (hsCRP) [Baseline to week 6]

Other Outcome Measures

Percent change in non-HDL-C [Baseline to week 6]
Percent change in total cholesterol [Baseline to week 6]
Percent change in apolipoprotein B (ApoB) [Baseline to week 6]
Change in body weight [Baseline to week 6]
Kg change in body weight from baseline to week 6
Plasma trough study drug pharmacokinetics [Baseline and week 6]
ETC-1002 and ESP15228 trough plasma concentrations

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Mean 24-hour ambulatory SBP greater than or equal to 130 mmHg
or- Mean 24-hour ambulatory DBP greater than or equal to 80 mmHg
Fasting LDL-C between 100 and 220 mg/dL
Fasting triglycerides less than 400 mg/dL
Body mass index (BMI) between 18 and 45 kg/m2

Exclusion Criteria:

Known or suspected secondary hypertension or history of malignant hypertension
Taking more than two anti-hypertension medications at the first visit
History or current clinically significant cardiovascular disease
History or current type 1 diabetes or type 2 diabetes

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Birmingham	Alabama	United States	35209
2	Chandler	Arizona	United States	85224
3	Phoenix	Arizona	United States	85006
4	DeLand	Florida	United States	32720
5	Fort Lauderdale	Florida	United States	33306
6	Hialeah	Florida	United States	33012
7	Pembroke Pines	Florida	United States	33026
8	Pembroke Pines	Florida	United States	33029
9	Port Orange	Florida	United States	32127
10	Gurnee	Illinois	United States	60031
11	Indianapolis	Indiana	United States	46260
12	Kansas City	Kansas	United States	66160
13	Paducah	Kentucky	United States	42003
14	Auburn	Maine	United States	04210
15	Olive Branch	Mississippi	United States	38654
16	Butte	Montana	United States	59701
17	Las Vegas	Nevada	United States	89123
18	Berlin	New Jersey	United States	08009
19	Endwell	New York	United States	13760
20	Wilmington	North Carolina	United States	28401
21	Cincinnati	Ohio	United States	45219
22	Cincinnati	Ohio	United States	45246
23	Willoughby Hills	Ohio	United States	44094
24	Eugene	Oregon	United States	97404
25	Downingtown	Pennsylvania	United States	19335
26	Charleston	South Carolina	United States	29407
27	Simpsonville	South Carolina	United States	29681
28	Corpus Christi	Texas	United States	78404
29	Dallas	Texas	United States	75230
30	Dallas	Texas	United States	75234
31	Houston	Texas	United States	77074
32	Salt Lake City	Utah	United States	84095
33	Salt Lake City	Utah	United States	84107
34	Kenosha	Wisconsin	United States	53142
35	Madison	Wisconsin	United States	53719