Back to resultsEfficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia
Primary Purpose
Hypertension, Hyperlipidemia
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Irbesartan/Atorvastatin A
Irbesartan
Atorvastatin A
Placebo
Irbesartan/Atorvastatin B
Atorvastatin B
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Irbesartan, Atorvastatin, Hypertension, Hyperlipidemia
Eligibility Criteria
Inclusion Criteria:
- Aged between 19 and 75 years
- Signed informed consent
Exclusion Criteria:
- At screening, SPB ≥ 180mmHg or DBP ≥ 110mmHg or LDL-C > 250mg/dL or TG ≥ 400mg/dL
- 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
Sites / Locations
- 16 institutions including Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Experimental
Active Comparator
Arm Label
Irbesartan/Atorvastatin A
Irbesartan
Atorvastatin A
Placebo
Irbesartan/Atorvastatin B
Atorvastatin B
Arm Description
Outcomes
Primary Outcome Measures
Percent change from baseline to 8 week in LDL-Cholesterol
Change from baseline to 8 week in Blood Pressure.
Secondary Outcome Measures
Percentage of patients reaching treatment goals according to NCEP ATP III Guideline and Blood pressure responder rate according to JNC VII Guideline.
Full Information
NCT ID
NCT01442987
First Posted
July 1, 2011
Last Updated
August 12, 2013
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT01442987
Brief Title
Efficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia
Official Title
Efficacy and Safety of Coadministered Irbesartan and Atorvastatin in Patients With Hypertension and Hyperlipidemia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate efficacy and safety of coadministered Irbesartan and Atorvastatin in patients with hypertension and hyperlipidemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hyperlipidemia
Keywords
Irbesartan, Atorvastatin, Hypertension, Hyperlipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Irbesartan/Atorvastatin A
Arm Type
Experimental
Arm Title
Irbesartan
Arm Type
Active Comparator
Arm Title
Atorvastatin A
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Irbesartan/Atorvastatin B
Arm Type
Experimental
Arm Title
Atorvastatin B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Irbesartan/Atorvastatin A
Other Intervention Name(s)
HCP0912 A
Intervention Description
once daily, P.O. 8week
Intervention Type
Drug
Intervention Name(s)
Irbesartan
Intervention Description
once daily, P.O. 8week
Intervention Type
Drug
Intervention Name(s)
Atorvastatin A
Intervention Description
once daily, P.O. 8week
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
once daily, P.O. 8week
Intervention Type
Drug
Intervention Name(s)
Irbesartan/Atorvastatin B
Other Intervention Name(s)
HCP0912 B
Intervention Description
once daily, P.O. 8week
Intervention Type
Drug
Intervention Name(s)
Atorvastatin B
Intervention Description
once daily, P.O. 8week
Primary Outcome Measure Information:
Title
Percent change from baseline to 8 week in LDL-Cholesterol
Time Frame
baseline and 8 week
Title
Change from baseline to 8 week in Blood Pressure.
Time Frame
baseline and 8 week
Secondary Outcome Measure Information:
Title
Percentage of patients reaching treatment goals according to NCEP ATP III Guideline and Blood pressure responder rate according to JNC VII Guideline.
Time Frame
week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged between 19 and 75 years
Signed informed consent
Exclusion Criteria:
At screening, SPB ≥ 180mmHg or DBP ≥ 110mmHg or LDL-C > 250mg/dL or TG ≥ 400mg/dL
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byeong Hee Oh, M.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
16 institutions including Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
27742464
Citation
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.
Results Reference
derived
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Efficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia
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