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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT01101204
Eligibility Criteria:
Inclusion Criteria:
* Age (35-64yr)
* Primary hyperlipidemia (Total cholesterol \>200mg/dl, Triglycerides \>150mg/dl)
* Type 2 Diabetes
* For women:
* Menopause (\>12 months)
* Post hysterectomy
* Mechanical contraception
* Obtained informed consent
Exclusion Criteria:
* Secondary hyperlipidemia
* Morbid obesity (BMI\>40kg/m2)
* Alcohol or drug abuse
* Acute or chronic inflammation
* Congestive Heart Failure (NYHA III or IV)
* Unstable Ischaemic Heart Disease
* Moderate or severe hypertension
* Cancer in less than 5 years
* Chronic kidney disease (stage III-V)
* Liver failure
* Oral contraception
* Not compliant patient
* Laboratory results:
* alanine transferase (\>3xULN)
* creatine kinase (\>5xULN)
* haemoglobin (\<10/dl)
* PLT (\<100G/l)
* WBC (\<3,5G/l or \>10G/l)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
64 Years
Study:
NCT01101204
Study Brief:
Protocol Section:
NCT01101204