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:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT01200160
Eligibility Criteria:
Inclusion Criteria
* Male and female subject \>18 years-old
* Subjects with primary hyperlipidemia or mixed dyslipidemia with elevated levels of total cholesterol,, LDL-C (low-density lipoprotein-cholesterol), triglycerides and/or decreased levels of HDL-C (high-density lipoprotein-cholesterol) (\< 40 mg/dL) and has demonstrated an inadequate response to a lipid-restricted diet and other non-pharmacologic measures alone such as exercise
* Subject has demonstrated persistent dyslipidemic values and/or inadequate response or intolerance to other pharmacologic therapies such as statins, fibrates, resins, etc.
* Female subjects with reproductive potential must use an approved contraceptive method (intrauterine device (IUD), birth control pills or barrier device) during and for 3 months after discontinuation of study treatment.
Exclusion Criteria
* Subject has been treated with any other investigational product in the last 30 days before the day of the screening visit
* Subject exhibits signs of acute illness with clinically relevant findings in the pre-study examination
* Subject has known hypersensitivity to niacin or any component of Niaspan®
* Subject has significant or unexplained hepatic and/or renal dysfunction
* Subject has active peptic ulcer disease
* Subject exhibits active arterial bleeding
* Subject is pregnant or lactating
* The mental condition of the subject renders him/her unable to understand the nature, scope, and possible consequences of the study
* Subject is unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01200160
Study Brief:
Protocol Section:
NCT01200160