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

A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-330 and D086 Combination Therapy in Hypertensive Patients With Dyslipidemia

To Evaluate the Efficacy and Safety of CKD-333

A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-330 and D086 Combination Therapy in Hypertensive Patients with Dyslipidemia

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