A Phase 3 Study to Compare the Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia
NCT ID: NCT04074551
Last Updated: 2020-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
145 participants
INTERVENTIONAL
2019-07-16
2020-03-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental
HCP1701
HCP1701
HCP1701
Active Comparator 1
HGP0904, HGP0608
Losartan
Losartan
Amlodipine
Amlodipine
Active Comparator 2
HGP0608, HCP1306
Losartan
Losartan
Rosuvastatin and Ezetimibe
Rosuvastatin and Ezetimibe
Interventions
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HCP1701
HCP1701
Losartan
Losartan
Amlodipine
Amlodipine
Rosuvastatin and Ezetimibe
Rosuvastatin and Ezetimibe
Eligibility Criteria
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Inclusion Criteria
* Patients who understood the contents and purpose of this trial and signed informed consent form
* Patients with essential hypertension and dyslipidemia
Exclusion Criteria
* 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
* Severe heart disease(heart failure of NYHA class III-IV)
* Severe cerebrovascular disease within 6 months (cerebral infarction, cerebral hemorrhage), hypertensive encephalopathy, transient cerebral ischemic attack(TIA)
* Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant stenosis in aortic valve or mitral valve
* Ischemic heart disease(myocardial infarction, angina) within 6months
* Angioplasty or coronary artery bypass graft(CABG) surgery within 6months
19 Years
ALL
No
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Hyo-Soo Kim, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, Seoul, South Korea
Countries
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References
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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.
Other Identifiers
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HM-AMOS-301
Identifier Type: -
Identifier Source: org_study_id