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to evaluate the efficacy and safety of CKD-828, D326, and D337 combination therapy in Hypertensive patients with Dyslipidemia
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | 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 |
|
| Comparator group 1 | Active Comparator | 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 |
|
| Comparator group 2 | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-828 | Drug | orally, 1 tablet once a day for 8 weeks |
| |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change and change rate from baseline in Low Density Lipoprotein-C, 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 |
Inclusion Criteria:
Exclusion Criteria:
Patients whose blood pressure measured at screening is one of the following:
Patients whose lipid level measured at screening is one of the following:
Patients diagnosed with secondary hypertension or suspected of secondary hypertension(coarctation of aorta, primary aldosteronism, etc).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ChangGyu Park, M.D, Ph.D | Contact | +82-2-2626-3019 | parkch@kumc.or.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| CKD-828(placebo) |
| Drug |
orally, 1 tablet once a day for 8 weeks |
|
| D326 | Drug | orally, 1 tablet once a day for 8 weeks |
|
| D326(placebo) | Drug | orally, 1 tablet once a day for 8 weeks |
|
| D337 | Drug | orally, 1 tablet once a day for 8 weeks |
|
| D337(placebo) | Drug | orally, 1 tablet once a day for 8 weeks |
|
| D013 | Drug | orally, 1 tablet once a day for 8 weeks |
|
| D013(placebo) | Drug | orally, 1 tablet once a day for 8 weeks |
|
| 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 |
| Baseline, 4 weeks, 8 weeks |
| Change from baseline in Mean Sitting Systolic Blood Pressure and Mean 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 |
| D009750 | Nutritional and Metabolic Diseases |