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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 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
Hypertension Hyperlipidemia 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
Intervention Model: Factorial Assignment
Masking: Double (Participant, 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 ]
  • Change from baseline to 8 week in Blood Pressure. [ Time Frame: baseline and 8 week ]

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 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its 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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hanmi Pharmaceutical Company Limited Identifier: NCT01442987     History of Changes
Other Study ID Numbers: HM-IBAT-301
Study First Received: July 1, 2011
Last Updated: August 12, 2013

Keywords provided by Hanmi Pharmaceutical Company Limited:

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists processed this record on September 19, 2017