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:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 12:17 PM
NCT ID:
NCT01554800
Eligibility Criteria:
Inclusion Criteria:
* A history of stable documented CAD
* Currently non-smoking males and females ages 30 to 85 years inclusive.
o Female subjects of child-bearing potential (neither pregnant nor breast-feeding) must be using adequate birth control during study conduct.
* Chronic concomitant medications must be stable for at least 2 months prior to screening
* HDL-C \< 50 mg/dL for men and \< 55 mg/dL for women
* Body Mass Index (BMI) of approximately 18 to 35 kg/m\^2; and a total body weight \>= 50 kg (110 lbs) and \<= 110 kg (approximately 242 lbs)
Exclusion Criteria:
* Myocardial infarction, stroke, or coronary intervention/revascularization procedure within 6 months prior to dosing.
* Chronic heart failure (\> New York Heart Association (NYHA) Functional Classification II).
* Ventricular tachyarrhythmias.
* Uncontrolled Type 2 (HbA1c \> 8.5%) or Type 1 diabetes mellitus.
* History of febrile illness within 5 days prior to dosing.
* History of regular alcohol consumption exceeding 10 drinks per week.
* 12-lead ECG demonstrating QTc \> 500 msec at screening.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
85 Years
Study:
NCT01554800
Study Brief:
Protocol Section:
NCT01554800