Efficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01442987
First received: July 1, 2011
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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
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

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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:
Irbesartan
Atorvastatin
Hypertension
Hyperlipidemia

Additional relevant MeSH terms:
Hyperlipidemias
Hypertension
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Atorvastatin
Irbesartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anticholesteremic Agents
Antihypertensive Agents
Antimetabolites
Cardiovascular Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014