Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-24 @ 1:06 PM
NCT ID:
NCT02072161
Eligibility Criteria:
Inclusion Criteria:
* Fasting, calculated mean LDL-C ≥130 mg/dL and ≤220 mg/dL
* Fasting mean TG level ≤400 mg/dL
* Stable statin therapy for at least 3 months prior to screening: atorvastatin (10 or 20 mg daily), simvastatin (5, 10 or 20 mg daily), rosuvastatin (5 or 10 mg daily), or pravastatin (10, 20 or 40 mg daily)
Exclusion Criteria:
* Clinically significant cardiovascular disease within 12 months of screening
* Current muscle-related symptoms that may be due to ongoing statin therapy or a history of certain lab abnormalities that occurred during statin therapy and resolved when statin therapy was discontinued
* Type 1 diabetes or uncontrolled type 2 diabetes
* Use of metformin or thiazolidinediones (TZD) within 4 weeks of screening
* History of chronic musculoskeletal symptoms such as fibromyalgia
* Uncontrolled hypothyroidism
* Liver disease or dysfunction
* Renal dysfunction or nephritic syndrome
* Gastrointestinal conditions or procedures or surgeries
* Hematologic or coagulation disorders or low hemoglobin levels
* HIV or AIDS
* History of malignancy
* History of drug or alcohol abuse within 2 years
* Use of experimental or investigational drugs within 30 days of screening
* Use of ETC-1002 in a previous clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02072161
Study Brief:
Protocol Section:
NCT02072161