Clinical Efficacy and Safety Evaluation of Co-administered HGP0904, HGP0608 and HGP0816 in Patients With Hypertension and Dyslipidemia
NCT ID: NCT02899455
Last Updated: 2016-10-20
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
146 participants
INTERVENTIONAL
2014-07-31
2016-06-30
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
HGP0904 + HGP0608 + HGP0816, once daily
HGP0904
HGP0608
HGP0816
Active Comparator1
HGP0904 placebo + HGP0608 + HGP0816, once daily
HGP0608
HGP0816
HGP0904 Placebo
Active Comparator2
HGP0904 + HGP0608 + HGP0816 placebo, once daily
HGP0904
HGP0608
HGP0816 Placebo
Interventions
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HGP0904
HGP0608
HGP0816
HGP0904 Placebo
HGP0816 Placebo
Eligibility Criteria
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Inclusion Criteria
2. at Visit 1 1) BP: sitDBP ≥ 90mmHg 2) Cholesterol : LDL-C ≤ 250mg/dL, TG \< 400mg/dL
3. at Visit 2 : after TLC (after 4weeks) 1) BP: 80 mmHg ≤ sitDBP \< 110mmHg 2) Cholesterol : following risk category (Cardiovascular Risk category) A : CHD risk factor 0 - 1, 160mg/dL ≤ LDL-C ≤ 250mg/dL B①: CHD risk factor≥2 and 10 year risk \<10%, 160mg/dL ≤ LDL-C ≤ 250mg/dL B②: CHD risk factor≥2 and 10 year risk =10-20%, 130mg/dL ≤ LDL-C ≤ 250mg/dL C : CHD/CHD risk equivalents\* or 10 year risk\>20 ,100mg/dL ≤ LDL-C ≤ 250mg/dL 3) TG \< 400mg/dL 4. Patients understood the contents and purpose of this trial and signed informed consent form
Exclusion Criteria
2. Tolerance or Hypersensitivity Angiotensin II receptor blocker or HMG-CoA. reductase inhibitor, Calcium channel blocker(dihydropyridine) or Multi-drug allergy
3. Fibromyalgia, myopathy, rhabdomyolysis or acute myopathy or medical history of adverse effect to statin
4. CPK normal range ≥ 3times
5. Uncontrolled primary hypothyroidism(TSH normal range ≥ 2 times)
6. Renal disease or suspected renal disease (Scr ≥ 2mg/dL, AST or ALT≥2 times)
7. Active gout or hyperuricemia(at Visit 1, uric acid \> 9mg/dL)
8. IDDM or uncontrolled diabetes mellitus (HbA1c\>9%)
9. ventricular arrhythmia
10. medical history
* severe cerebrovascular disease within 6 months (cerebral infarction, cerebral hemorrhage), hypertension
* encephalopathy, transient cerebral ischemic attack(TIA)
* severe heart disease(heart failure of NYHA class III-IV), valvular disease of heart or myocardial infarction and unstable angina
* angioplasty or coronary artery bypass graft(CABG) surgery within 6months
19 Years
75 Years
ALL
No
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Locations
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23 institutions including Samsung Medical Center
Seoul, , South Korea
Countries
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References
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Lee HY, Kim SY, Choi KJ, Yoo BS, Cha DH, Jung HO, Ryu DR, Choi JH, Lee KJ, Park TH, Oh JH, Kim SM, Choi JY, Kim KH, Shim J, Kim WS, Choi SW, Park DG, Song PS, Hong TJ, Rhee MY, Rha SW, Park SW. A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and the Tolerability of a Triple Combination of Amlodipine/Losartan/Rosuvastatin in Patients With Comorbid Essential Hypertension and Hyperlipidemia. Clin Ther. 2017 Dec;39(12):2366-2379. doi: 10.1016/j.clinthera.2017.10.013. Epub 2017 Nov 14.
Other Identifiers
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HM-ALRO-301
Identifier Type: -
Identifier Source: org_study_id
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