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NCT01442987 Clinical Trial

Efficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia

Hypertension Clinical Trial

Official title:
Efficacy and Safety of Coadministered Irbesartan and Atorvastatin in Patients With Hypertension and Hyperlipidemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01442987
Other study ID # HM-IBAT-301
Secondary ID
Status Completed
Phase Phase 3
First received July 1, 2011
Last updated August 12, 2013
Start date May 2011
Est. completion date May 2013

Study information
Verified date August 2013
Source Hanmi Pharmaceutical Company Limited
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate efficacy and safety of coadministered Irbesartan and Atorvastatin in patients with hypertension and hyperlipidemia.

Recruitment information / eligibility
Status Completed
Enrollment 230
Est. completion date May 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 75 Years
Eligibility 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 ? receptor blocker or HMG-CoA reductase inhibitor or component of this drug

- Has a history of multi-drug allergy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• 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

Locations
Country Name City State
Korea, Republic of 16 institutions including Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent change from baseline to 8 week in LDL-Cholesterol baseline and 8 week No
Primary Change from baseline to 8 week in Blood Pressure. baseline and 8 week No
Secondary Percentage of patients reaching treatment goals according to NCEP ATP III Guideline and Blood pressure responder rate according to JNC VII Guideline. week 8 No
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