Hyperlipidemia, Hypertension
Conditions
Keywords
Irbesartan, Atorvastatin, Hypertension, Hyperlipidemia
Brief summary
The purpose of this study is to evaluate efficacy and safety of coadministered Irbesartan and Atorvastatin in patients with hypertension and hyperlipidemia.
Interventions
DRUGIrbesartan/Atorvastatin A
once daily, P.O. 8week
DRUGIrbesartan
once daily, P.O. 8week
DRUGAtorvastatin A
once daily, P.O. 8week
DRUGPlacebo
once daily, P.O. 8week
DRUGIrbesartan/Atorvastatin B
once daily, P.O. 8week
DRUGAtorvastatin B
once daily, P.O. 8week
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Percentage of patients reaching treatment goals according to NCEP ATP III Guideline and Blood pressure responder rate according to JNC VII Guideline. | week 8 |
Countries
South Korea
Outcome results
None listed