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 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
NCT ID:
NCT01342666
Eligibility Criteria:
Inclusion Criteria:
* Males with HDL-c less than 40 mg/dl
* Females with HDL-c less than 50 mg/dl
* Age between 18 to 65 years old
* Acceptance for participation with signed informed consent
Exclusion Criteria:
Previous diagnosis of:
* Diabetes,
* Hypertension,
* Kidney, liver or heart insufficiency,
* Hyperuricemia,
* Hyperandrogenic anovulation,
* Thyroid dysfunction (hypo or hyperthyroidism),
* Any difficulty to swallow appropriately, or
* Hospitalization in the previous six months.
Additionally, those subjects under current treatment with fibrates, statins, nicotinic acid, steroids, allopurinol, hormone replacement therapy (testosterone, estrogens or progesterone), metformin, other oral hypoglycemic agents, insulin, sibutramine, or orlistat treatment and those with daily consumption of any non-steroidal anti-inflammatory drug were also excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01342666
Study Brief:
Protocol Section:
NCT01342666