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 @ 12:37 PM
Ignite Modification Date:
2025-12-24 @ 12:37 PM
NCT ID:
NCT01982461
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged 20 to 85;
* LDL - C between 130 mg/dL and 250 mg/dL;
* TG \< 400 mg/dL;
* Who without use of any statin within 2 week prior to the trial;
* Informed consent given.
Exclusion Criteria:
* Known hypersensitivity or history of SAE with another HMG-CoA reductase inhibitor, in particular any history of myopathy;
* Active liver disease/severe hepatic impairment(Child-Pugh C,ALT2×ULN);
* Treatment with Cyclosporin or any disallowed drug;
* Patients with unstable angina pectoris;
* Pregnant, lactating women;
* Patients who have severe medical condition(s) that in the view of the Investigator prohibits participation in the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
85 Years
Study:
NCT01982461
Study Brief:
Protocol Section:
NCT01982461