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

Study Overview
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Brief Summary
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To Evaluate the Efficacy and Safety of CKD-333

Detailed Description
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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

Official Title
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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

Conditions
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Hypertensive Patients With Dyslipidemia

Intervention / Treatment
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* Drug: CKD-330
* Drug: Placebo of CKD-330
* Drug: D086
* Drug: Placebo of D086
* Drug: D723
* Drug: Placebo of D723


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a mean sitting systolic blood pressure (MSSBP) ≥ 140 mmHg measured on selected arms after run-in period 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: Patients whose blood pressures measured at Visit 2 were: Patients with MSSBP ≥ 180 mmHg and / or MSDBP ≥ 110 mmHg 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group 1<br>Patients assigned to this group are treated with CKD-330, D086 | Drug: CKD-330<br>* CKD-330 Tab.<br>Drug: D086<br>* D086 Tab.<br>Drug: Placebo of D723<br>* Placebo of D723 Tab.<br>|
| Placebo Comparator: Placebo Group 1<br>Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the D086) | Drug: CKD-330<br>* CKD-330 Tab.<br>Drug: Placebo of D086<br>* Placebo of D086 Tab.<br>Drug: Placebo of D723<br>* Placebo of D723 Tab.<br>|
| Placebo Comparator: Placebo Group 2<br>Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the CKD-330) | Drug: Placebo of CKD-330<br>* Placebo of CKD-330 Tab.<br>Drug: D086<br>* D086 Tab.<br>Drug: D723<br>* D723 Tab.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change rate from baseline in LDL-C | Compare experimental group 1 with placebo group 1 | 8 weeks after drug administrations | 
| Change from baseline in MSSBP | Compare experimental group 1 with placebo group 2 | 8 weeks after drug administrations | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change rate from baseline in LDL-C | Compare experimental group 1 with placebo group 1 | 4 weeks after drug administrations | 
| Change from baseline in LDL-C | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations | 
| Attainment of LDL-C treatment goal as defined by NCEP ATP Ⅲ Guideline | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations | 
| Change from baseline in MSSBP(mmHg) | Compare experimental group 1 with placebo group 2 | 4 weeks after drug administrations | 
| Change from baseline in MSDBP | Compare experimental group 1 with placebo group 2 | 4, 8 weeks after drug administrations | 
| Attainment of normal blood pressure as defined by JNC Ⅶ | Compare experimental group 1 with placebo group 2 | 4, 8 weeks after drug administrations | 
| Change from baseline in TC | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations | 
| Change from baseline in TG | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations | 
| Change from baseline in HDL-C | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations | 
| change rate from baseline in TC | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations | 
| change rate from baseline in TG | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations | 
| change rate from baseline in HDL-C | Compare experimental group 1 with placebo group 1 | 4, 8 weeks after drug administrations |