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Efficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia

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ClinicalTrials.gov Identifier: NCT01442987
Recruitment Status : Completed
First Posted : September 29, 2011
Last Update Posted : August 13, 2013
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

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

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 230 participants
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
Study Start Date : May 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Percent change from baseline to 8 week in LDL-Cholesterol [ Time Frame: baseline and 8 week ]
  2. Change from baseline to 8 week in Blood Pressure. [ Time Frame: baseline and 8 week ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01442987


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01442987     History of Changes
Other Study ID Numbers: HM-IBAT-301
First Posted: September 29, 2011    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: August 2013

Keywords provided by Hanmi Pharmaceutical Company Limited:
Irbesartan
Atorvastatin
Hypertension
Hyperlipidemia

Additional relevant MeSH terms:
Hypertension
Hyperlipidemias
Hyperlipoproteinemias
Vascular Diseases
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Irbesartan
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
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