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A Randomized, Double-blinded, Multi-center, Phase III Study to Compare The Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 versus HCP1701 in Patients with Hypertension and Dyslipidemia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | HCP1701 |
|
| Active Comparator 1 | Active Comparator | HGP0904, HGP0608 |
|
| Active Comparator 2 | Active Comparator | HGP0608, HCP1306 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCP1701 | Drug | HCP1701 |
| |
| Losartan |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in LDL-C (%) | Experimental, Active Control 1 | baseline, 8 weeks |
| Change from baseline in sitting systolic blood pressure | Experimental, Active Control 2 | baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in LDL-C (%) | Experimental, Active Control 2 | baseline, 8 weeks |
| Change from baseline in sitting systolic blood pressure | Experimental, Active Control 1 |
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Inclusion Criteria:
Exclusion Criteria:
Patients with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
Patients with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg
Concomitant administration of cyclosporine
Tolerance or Hypersensitivity Angiotensin II receptor blocker or HMG-CoA reductase inhibitor, Calcium channel blocker(dihydropyridine) or Multi-drug allergy
Hereditary angioedema or medical history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor blockers
Fibromyalgia, myopathy, rhabdomyolysis or acute myopathy or medical history of adverse effect to statin
CPK normal range > 2 times
Secondary hypertension and suspected secondary hypertension
Orthostatic hypotension with symptoms
Uncontrolled primary hypothyroidism(TSH normal range ≥ 1.5 times)
Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
Active gout or hyperuricemia(uric acid ≥ 9mg/dL)
IDDM or uncontrolled type 2 diabetes mellitus (HbA1c > 9%)
Ventricular arrhythmia
Medical history
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| Name | Affiliation | Role |
|---|---|---|
| Hyo-Soo Kim, M.D., Ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37395974 | Derived | Kim MC, Ahn Y, Kim MH, Kim SY, Hong TJ, Rhee MY, Kim SH, Hong SJ, Kim H, Kim W, Chae IH, Kang DH, Kim BK, Kim HS. A Randomized, Multicenter, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Quadruple Combination of Amlodipine, Losartan, Rosuvastatin, and Ezetimibe in Patients with Concomitant Essential Hypertension and Dyslipidemia. Am J Cardiovasc Drugs. 2023 Jul;23(4):441-454. doi: 10.1007/s40256-023-00590-9. Epub 2023 Jul 3. |
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| Drug |
Losartan |
|
| Amlodipine | Drug | Amlodipine |
|
| Rosuvastatin and Ezetimibe | Drug | Rosuvastatin and Ezetimibe |
|
| baseline, 8 weeks |
| Change from baseline in LDL-C (%) | baseline, 4 weeks |
| Change from baseline in sitting systolic blood pressure | baseline, 4 weeks |
| Change from baseline in TC, HDL-C, TG (%) | baseline, 4 weeks, 8 weeks |
| Change from baseline in sitting distolic blood pressure | baseline, 4 weeks, 8 weeks |
| Proportion of subject achieving LDL-C control | baseline, 4 weeks, 8 weeks |
| Proportion of subjects achieving blood pressure control | baseline, 4 weeks, 8 weeks |
| Proportion of responder for blood pressure | baseline, 4 weeks, 8 weeks |
| Proportion of subject achieving both LDL-C and blood pressure control | baseline, 4 weeks, 8 weeks |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019808 | Losartan |
| D017311 | Amlodipine |
| D000068718 | Rosuvastatin Calcium |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D001384 | Azetidines |
| D001385 | Azetines |
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