Efficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia

August 12, 2013 updated by: Hanmi Pharmaceutical Company Limited

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • 16 institutions including Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
once daily, P.O. 8week
Active Comparator: Irbesartan
Drug: Irbesartan
once daily, P.O. 8week
Experimental: Irbesartan/Atorvastatin A
Drug: Irbesartan/Atorvastatin A
once daily, P.O. 8week
Other Names:
  • HCP0912 A
Active Comparator: Atorvastatin A
Drug: Atorvastatin A
once daily, P.O. 8week
Experimental: Irbesartan/Atorvastatin B
Drug: Irbesartan/Atorvastatin B
once daily, P.O. 8week
Other Names:
  • HCP0912 B
Active Comparator: Atorvastatin B
Drug: Atorvastatin B
once daily, P.O. 8week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline to 8 week in LDL-Cholesterol
Time Frame: baseline and 8 week
baseline and 8 week
Change from baseline to 8 week in Blood Pressure.
Time Frame: baseline and 8 week
baseline and 8 week

Secondary Outcome Measures

Outcome Measure
Time Frame
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
week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Principal Investigator: Byeong Hee Oh, M.D, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

July 1, 2011

First Submitted That Met QC Criteria

September 28, 2011

First Posted (Estimate)

September 29, 2011

Study Record Updates

Last Update Posted (Estimate)

August 13, 2013

Last Update Submitted That Met QC Criteria

August 12, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-IBAT-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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