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

1002-014

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

2014-06-16

2015-05-22

2015-05-22

Completed

Early phase I

143

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 143, 'type': 'ACTUAL'}}

2023-04-04