Efficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia

This study has been completed.
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
First received: July 1, 2011
Last updated: August 12, 2013
Last verified: August 2013
The purpose of this study is to evaluate efficacy and safety of coadministered Irbesartan and Atorvastatin in patients with hypertension and hyperlipidemia.

Condition Intervention Phase
Drug: Irbesartan/Atorvastatin A
Drug: Irbesartan
Drug: Atorvastatin A
Drug: Placebo
Drug: Irbesartan/Atorvastatin B
Drug: Atorvastatin B
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Coadministered Irbesartan and Atorvastatin in Patients With Hypertension and Hyperlipidemia

Resource links provided by NLM:

Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • Percent change from baseline to 8 week in LDL-Cholesterol [ Time Frame: baseline and 8 week ] [ Designated as safety issue: No ]
  • Change from baseline to 8 week in Blood Pressure. [ Time Frame: baseline and 8 week ] [ Designated as safety issue: No ]

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. [ Time Frame: week 8 ] [ Designated as safety issue: No ]

Enrollment: 230
Study Start Date: May 2011
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Irbesartan/Atorvastatin A Drug: Irbesartan/Atorvastatin A
once daily, P.O. 8week
Other Name: HCP0912 A
Active Comparator: Irbesartan Drug: Irbesartan
once daily, P.O. 8week
Active Comparator: Atorvastatin A Drug: Atorvastatin A
once daily, P.O. 8week
Placebo Comparator: Placebo Drug: Placebo
once daily, P.O. 8week
Experimental: Irbesartan/Atorvastatin B Drug: Irbesartan/Atorvastatin B
once daily, P.O. 8week
Other Name: HCP0912 B
Active Comparator: Atorvastatin B Drug: Atorvastatin B
once daily, P.O. 8week


Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01442987

Korea, Republic of
16 institutions including Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Principal Investigator: Byeong Hee Oh, M.D Seoul National University Hospital
  More Information

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01442987     History of Changes
Other Study ID Numbers: HM-IBAT-301 
Study First Received: July 1, 2011
Last Updated: August 12, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanmi Pharmaceutical Company Limited:

Additional relevant MeSH terms:
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Atorvastatin Calcium
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anticholesteremic Agents
Antihypertensive Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 25, 2016