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 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT03583905
Eligibility Criteria:
Inclusion Criteria:
1. Patients with a mean sitting systolic blood pressure (MSSBP) ≥ 140 mmHg measured on selected arms after run-in period
2. Lipid levels measured after run-in period were:
* Group 1: hypertension + dyslipidemia only → fasting LDL-C ≥ 160 mg / dL
* Group 2: hypertension + dyslipidemia + cardiovascular risk factor more than 1 → fasting LDL-C ≥ 130mg / dL
* Group 3: hypertension + dyslipidemia + coronary artery disease or equivalent or 10-year risk assessed by Framingham Point Score greater than 20% → fasting LDL-C ≥ 100 mg / dL
Exclusion Criteria:
1. Patients whose blood pressures measured at Visit 2 were:
* Patients with MSSBP ≥ 180 mmHg and / or MSDBP ≥ 110 mmHg
2. Patients who had lipid levels measured at Visit 2
* Patients with fasting LDL-C \<100 mg / dL or fasting LDL-C\> 250 mg / dL and / or TG ≥ 500 mg / dL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03583905
Study Brief:
Protocol Section:
NCT03583905