Efficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia
Efficacy and Safety of Coadministered Irbesartan and Atorvastatin in Patients With Hypertension and Hyperlipidemia
1 other identifier
interventional
230
1 country
1
Brief Summary
The purpose of this study is to evaluate efficacy and safety of coadministered Irbesartan and Atorvastatin in patients with hypertension and hyperlipidemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hypertension
Started May 2011
Typical duration for phase_3 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 1, 2011
CompletedFirst Posted
Study publicly available on registry
September 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedAugust 13, 2013
August 1, 2013
1.9 years
July 1, 2011
August 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percent change from baseline to 8 week in LDL-Cholesterol
baseline and 8 week
Change from baseline to 8 week in Blood Pressure.
baseline and 8 week
Secondary Outcomes (1)
Percentage of patients reaching treatment goals according to NCEP ATP III Guideline and Blood pressure responder rate according to JNC VII Guideline.
week 8
Study Arms (6)
Irbesartan/Atorvastatin A
EXPERIMENTALIrbesartan
ACTIVE COMPARATORAtorvastatin A
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORIrbesartan/Atorvastatin B
EXPERIMENTALAtorvastatin B
ACTIVE COMPARATORInterventions
once daily, P.O. 8week
once daily, P.O. 8week
Eligibility Criteria
You may qualify if:
- Aged between 19 and 75 years
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
16 institutions including Seoul National University Hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 27742464DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Byeong Hee Oh, M.D
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2011
First Posted
September 29, 2011
Study Start
May 1, 2011
Primary Completion
April 1, 2013
Study Completion
May 1, 2013
Last Updated
August 13, 2013
Record last verified: 2013-08