Efficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia
NCT ID: NCT01442987
Last Updated: 2013-08-13
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
230 participants
INTERVENTIONAL
2011-05-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Irbesartan/Atorvastatin A
Irbesartan/Atorvastatin A
once daily, P.O. 8week
Irbesartan
Irbesartan
once daily, P.O. 8week
Atorvastatin A
Atorvastatin A
once daily, P.O. 8week
Placebo
Placebo
once daily, P.O. 8week
Irbesartan/Atorvastatin B
Irbesartan/Atorvastatin B
once daily, P.O. 8week
Atorvastatin B
Atorvastatin B
once daily, P.O. 8week
Interventions
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Irbesartan/Atorvastatin A
once daily, P.O. 8week
Irbesartan
once daily, P.O. 8week
Atorvastatin A
once daily, P.O. 8week
Placebo
once daily, P.O. 8week
Irbesartan/Atorvastatin B
once daily, P.O. 8week
Atorvastatin B
once daily, P.O. 8week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
Exclusion Criteria
* Has a history of hypersensitivity to Angiotensin Ⅱ receptor blocker or HMG-CoA reductase inhibitor or component of this drug
* Has a history of multi-drug allergy
19 Years
75 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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Byeong Hee Oh, M.D
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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16 institutions including Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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Kim SH, Jo SH, Lee SC, Lee SY, Yoon MH, Lee HL, Lee NH, Ha JW, Lee NH, Kim DW, Han GR, Hyon MS, Cho DG, Park CG, Kim YD, Ryu GH, Kim CH, Kim KS, Chung MH, Chae SC, Seung KB, Oh BH. Blood Pressure and Cholesterol-lowering Efficacy of a Fixed-dose Combination With Irbesartan and Atorvastatin in Patients With Hypertension and Hypercholesterolemia: A Randomized, Double-blind, Factorial, Multicenter Phase III Study. Clin Ther. 2016 Oct;38(10):2171-2184. doi: 10.1016/j.clinthera.2016.09.005. Epub 2016 Oct 12.
Other Identifiers
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HM-IBAT-301
Identifier Type: -
Identifier Source: org_study_id