search
Back to results

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

Primary Purpose

Hypercholesterolemia

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rosuvastatin/Ezetimibe
Sponsored by
IlDong Pharmaceutical Co Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring cholesterol

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hypercholesterolemic patient

Exclusion Criteria:

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

Sites / Locations

  • Gil Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Experimental

Experimental

Experimental

Arm Label

R5

R10

R20

R5/E10

R10/E10

R20/E10

Arm Description

Rosuvastatin 5mg

Rosuvastatin 10mg

Rosuvastatin 20mg

Rosuvastatin 5mg/ezetimibe 10mg

Rosuvastatin 10mg/ezetimibe 10mg

Rosuvastatin 20mg/ezetimibe 10mg

Outcomes

Primary Outcome Measures

Percent change from baseline to 8 week in LDL-Cholesterol

Secondary Outcome Measures

Percent change from baseline to 4 week in LDL-Cholesterol

Full Information

First Posted
September 25, 2014
Last Updated
September 25, 2014
Sponsor
IlDong Pharmaceutical Co Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT02251847
Brief Title
The Efficacy and Safety of a Combination Therapy of Rosuvastatin and Ezetimibe Versus Monotherapy of Rosuvastatin in Hypercholesterolemia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IlDong Pharmaceutical Co Ltd

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
cholesterol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
R5
Arm Type
Active Comparator
Arm Description
Rosuvastatin 5mg
Arm Title
R10
Arm Type
Active Comparator
Arm Description
Rosuvastatin 10mg
Arm Title
R20
Arm Type
Active Comparator
Arm Description
Rosuvastatin 20mg
Arm Title
R5/E10
Arm Type
Experimental
Arm Description
Rosuvastatin 5mg/ezetimibe 10mg
Arm Title
R10/E10
Arm Type
Experimental
Arm Description
Rosuvastatin 10mg/ezetimibe 10mg
Arm Title
R20/E10
Arm Type
Experimental
Arm Description
Rosuvastatin 20mg/ezetimibe 10mg
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin/Ezetimibe
Intervention Description
Rosuvastatin 5mg
Primary Outcome Measure Information:
Title
Percent change from baseline to 8 week in LDL-Cholesterol
Time Frame
baseline and 8 week
Secondary Outcome Measure Information:
Title
Percent change from baseline to 4 week in LDL-Cholesterol
Time Frame
baseline and 4 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hypercholesterolemic patient Exclusion Criteria: Has history of hypersensitivity to HMG-CoA reductase inhibitor and Ezetimibe
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min-Hee Kwon
Phone
02-526-3379
Email
minhee@ildong.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae Hoon Ahn
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gil Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Hoon Ahn

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs