Clinical Study to Evaluate the Efficacy and Safety of CKD-348(CKD-828, D326, D337) Tablet

Study Overview
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Brief Summary
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to evaluate the efficacy and safety of CKD-828, D326, and D337 combination therapy in Hypertensive patients with Dyslipidemia

Detailed Description
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The purpose of this phase III study was to evaluate the efficacy and safety of CKD-348(CKD-828, D326, D337) tablet administration for treatment period(8 weeks) in essential hypertesive patients with Dyslipidemia.

Official Title
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A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-828, D326, and D337 Combination Therapy in Hypertensive Patients With Dyslipidemia

Conditions
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Hypertension, Dyslipidemias

Intervention / Treatment
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* Drug: CKD-828
* Drug: CKD-828(placebo)
* Drug: D326
* Drug: D326(placebo)
* Drug: D337
* Drug: D337(placebo)
* Drug: D013
* Drug: D013(placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 19 years and 75 years old(male or female) Diagnosed essential hypertensive patients with dyslipidemia or the patients who has been taking antihypertensive and antidyslipidemic drugs The patients who can stop taking antihypertensive and antidyslipidemic drugs accroding to Principle Investigator's opinion Agreement with written informed consent Exclusion Criteria: Patients whose blood pressure measured at screening is one of the following: Mean Sitting Systolic Blood Pressure ≥ 200 mmHg or Mean Sitting Diastolic Blood Pressure ≥ 120 mmHg Difference in Mean Sitting Systolic Blood Pressure between patient's both arms ≥ 20 mmHg and Mean Sitting Diastolic Blood Pressure ≥ 10 mmHg Patients whose lipid level measured at screening is one of the following: Low Density Lipoprotein-C > 250 mg/dL or Triglyceride ≥ 500 mg/dL Patients diagnosed with secondary hypertension or suspected of secondary hypertension(coarctation of aorta, primary aldosteronism, etc).

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Drug: CKD-828 80/5mg, D326 20mg, D337 10mg, D013(placebo) 80mg - CKD-828 80/5mg, D326 20mg, D337 10mg, D013(placebo) 80mg, orally, 1 tablet once a day for 8 weeks | Drug: CKD-828<br>* orally, 1 tablet once a day for 8 weeks<br>Drug: D326<br>* orally, 1 tablet once a day for 8 weeks<br>Drug: D337<br>* orally, 1 tablet once a day for 8 weeks<br>Drug: D013(placebo)<br>* orally, 1 tablet once a day for 8 weeks<br>|
| Active Comparator: Comparator group 1<br>Drug: CKD-828 80/5mg, D326(placebo) 20mg, D337(placebo) 10mg, D013(placebo) 80mg - CKD-828 80/5mg, D326(placebo) 20mg, D337(placebo) 10mg, D337(placebo) 10mg, D013(placebo) 80mg, orally, 1 tablet once a day for 8 weeks | Drug: CKD-828<br>* orally, 1 tablet once a day for 8 weeks<br>Drug: D326(placebo)<br>* orally, 1 tablet once a day for 8 weeks<br>Drug: D337(placebo)<br>* orally, 1 tablet once a day for 8 weeks<br>Drug: D013(placebo)<br>* orally, 1 tablet once a day for 8 weeks<br>|
| Active Comparator: Comparator group 2<br>Drug: CKD-828(placebo) 80/5mg, D326 20mg, D337 10mg, D013 80mg - CKD-828(placebo) 80/5mg, D326 20mg, D337 10mg, D013 80mg, orally, 1 tablet once a day for 8 weeks | Drug: CKD-828(placebo)<br>* orally, 1 tablet once a day for 8 weeks<br>Drug: D326<br>* orally, 1 tablet once a day for 8 weeks<br>Drug: D337<br>* orally, 1 tablet once a day for 8 weeks<br>Drug: D013<br>* orally, 1 tablet once a day for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change rate from baseline in Low Density Lipoprotein-C | (compare treatment group with comparator group 1) | Baseline, 8 weeks | 
| Change from baseline in Mean Sitting Systolic Blood Pressure | (compare treatment group with comparator group 2) | Baseline, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change rate from baseline in Low Density Lipoprotein-C |  | Baseline, 4 weeks | 
| Change from baseline in Low Density Lipoprotein-C |  | Baseline, 4 weeks, 8 weeks | 
| Change and change rate from baseline in Total Cholesterol, Triglyceride, High Density Lipoprotein-C |  | Baseline, 4 weeks, 8 weeks | 
| Low Density Lipoprotein-C target achievement rate accroding to National Cholesterol Education Program(NCEP) Third Adult Treatment Panel(ATP III) guideline at 4 weeks and 8 weeks |  | Baseline, 4 weeks, 8 weeks | 
| Change from baseline in Mean Sitting Systolic Blood Pressure |  | Baseline, 4 weeks | 
| Change from baseline in Mean Sitting Diastolic Blood Pressure |  | Baseline, 4 weeks, 8 weeks | 
| Normalization rate of blood pressure after 4 weeks and 8 weeks | Blood Pressure < 140/90 mmHg | Baseline, 4 weeks, 8 weeks |