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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT01288469
Eligibility Criteria:
Inclusion criteria:
\- Participants receiving a lipid-lowering treatment other than atorvastatin/ or not at stable dose of atorvastatin 10 mg for at least 6 weeks prior to screening, or drug naive participants with primary hypercholesterolemia if they are likely to have low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (≥ 2.59 mmol/L) at the end of the 6-week run-in treatment period on atorvastatin therapy
OR
\- Participants with primary hypercholesterolemia treated with stable dose of atorvastatin 10 mg for at least 6 weeks prior to screening and likely to have low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (≥ 2.59 mmol/L) at the screening visit.
Exclusion criteria:
1. LDL-C \< 100 mg/dL (\< 2.59 mmol/L) at Week -1 (V1):
* After the run-in period on atorvastatin 10 mg for participants receiving a lipid lowering treatment other than atorvastatin/ or not at stable dose of atorvastatin 10 mg for at least 6 weeks prior to the screening period, or drug naive participants.
OR
* At the first visit for participants who are being treated with atorvastatin 10 mg at stable dose for at least 6 weeks prior to screening visit.
2. Participants not previously instructed on a cholesterol-lowering diet.
3. Participants with type 1 diabetes.
4. Participants with type 2 diabetes treated with insulin.
5. Participants with type 2 diabetes and with an HbA1c ≥ 8.5% at screening visit (considered poorly controlled).
6. Laboratory findings measured before randomization:
* Triglycerides (TG) \> 350 mg/dL (\> 3.95 mmol/L) at screening visit.
* Positive serum or urine pregnancy test in females of childbearing potential.
7. Pregnant or breast-feeding women.
8. Women of childbearing potential with no effective contraceptive method.
The above information is not intended to contain all considerations relevant to a Participant's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01288469
Study Brief:
Protocol Section:
NCT01288469