Clinical Trial to Evaluate the Efficacy and Safety of CKD-333 Tablet

• Status: Completed
• Trial end date: 2019-07-17
• Target enrollment: 0
• Participant gender: All

Summary

To Evaluate the Efficacy and Safety of CKD-333

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical

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