Evaluation of ETC-1002 in Participants With Hypercholesterolemia and Hypertension

Esperion Therapeutics

Status and phase: Completed; Phase 2

Conditions: Hypertension; Hypercholesterolemia

Treatments: Drug: Placebo; Drug: ETC-1002

Study type: Interventional

Funder types: Industry

Identifiers

NCT02178098

1002-014

Details and patient eligibility

About

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

Enrollment: 143 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

143 participants in 2 patient groups, including a placebo group

ETC-1002

Experimental group

Description:

ETC-1002 180 mg/day

Treatment:

Drug: ETC-1002

Placebo

Placebo Comparator group

Description:

Placebo control

Treatment:

Drug: Placebo