The Efficacy and Safety of a Combination Therapy of Rosuvastatin and Ezetimibe Versus Monotherapy of Rosuvastatin in Hypercholesterolemia Patients

September 25, 2014 updated by: IlDong Pharmaceutical Co Ltd
To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients

Study Type

Interventional

Enrollment (Anticipated)

400

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 Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Gil Medical Center
        • Contact:
          • Tae Hoon Ahn

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

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hypercholesterolemic patient

Exclusion Criteria:

  • Has history of hypersensitivity to HMG-CoA reductase inhibitor and Ezetimibe

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: R5
Rosuvastatin 5mg
Drug: Rosuvastatin/Ezetimibe
Rosuvastatin 5mg
Active Comparator: R10
Rosuvastatin 10mg
Drug: Rosuvastatin/Ezetimibe
Rosuvastatin 5mg
Active Comparator: R20
Rosuvastatin 20mg
Drug: Rosuvastatin/Ezetimibe
Rosuvastatin 5mg
Experimental: R5/E10
Rosuvastatin 5mg/ezetimibe 10mg
Drug: Rosuvastatin/Ezetimibe
Rosuvastatin 5mg
Experimental: R10/E10
Rosuvastatin 10mg/ezetimibe 10mg
Drug: Rosuvastatin/Ezetimibe
Rosuvastatin 5mg
Experimental: R20/E10
Rosuvastatin 20mg/ezetimibe 10mg
Drug: Rosuvastatin/Ezetimibe
Rosuvastatin 5mg

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline to 4 week in LDL-Cholesterol
Time Frame: baseline and 4 week
baseline and 4 week

Collaborators and Investigators

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

Sponsor

IlDong Pharmaceutical Co Ltd

Investigators

  • Principal Investigator: Tae Hoon Ahn, Gachon University Gil Medical Center

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

July 1, 2014

Primary Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

September 25, 2014

First Submitted That Met QC Criteria

September 25, 2014

First Posted (Estimate)

September 29, 2014

Study Record Updates

Last Update Posted (Estimate)

September 29, 2014

Last Update Submitted That Met QC Criteria

September 25, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID-ROEZ-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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