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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT00385658
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent to participate in the study prior to any study procedures.
* Male or female subjects, age between 18-75 years inclusive.
* All women of child bearing potential must have a negative pregnancy test
* Metabolic Syndrome according to the International Diabetes Federation definition:
* Low plasma HDL-C (Men \< 40 mg/dl ; Women \< 50 mg/dl ).
* Elevated waist circumference (men ≥ 94 cm, women ≥ 80cm)
* And one or more of the following criteria:
* Triglycerides ≥ 150 mg/d.l
* Raised blood pressure (DBP ≥ 85 mmHg and/or SBP ≥ 130mmHg ) or treated hypertension.
* Fasting plasma glucose≥ 100mg/dl.
* Previously diagnosed type 2 diabetes.
Exclusion Criteria:
* Dyslipidemia secondary to other causes such as nephrotic syndrome, autoimmune disease.
* Type 1 diabetes.
* HbA1c \> 9.5%.
* Unexplained serum creatine phosphokinase \> 2 x Upper limit of normal.
* History of myocardial infarction and/or cerebral stroke and/or unstable angina pectoris.
* Known or suspected contraindications and warnings according to the country specific label for the investigational drugs.
Other protocol-defined inclusion/exclusion criteria may apply.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00385658
Study Brief:
Protocol Section:
NCT00385658