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

NCT ID: NCT02251847

Last Updated: 2014-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Brief Summary

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

Detailed Description

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

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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R5

Rosuvastatin 5mg

Group Type ACTIVE_COMPARATOR

Rosuvastatin/Ezetimibe

Intervention Type DRUG

Rosuvastatin 5mg

R10

Rosuvastatin 10mg

Group Type ACTIVE_COMPARATOR

Rosuvastatin/Ezetimibe

Intervention Type DRUG

Rosuvastatin 5mg

R20

Rosuvastatin 20mg

Group Type ACTIVE_COMPARATOR

Rosuvastatin/Ezetimibe

Intervention Type DRUG

Rosuvastatin 5mg

R5/E10

Rosuvastatin 5mg/ezetimibe 10mg

Group Type EXPERIMENTAL

Rosuvastatin/Ezetimibe

Intervention Type DRUG

Rosuvastatin 5mg

R10/E10

Rosuvastatin 10mg/ezetimibe 10mg

Group Type EXPERIMENTAL

Rosuvastatin/Ezetimibe

Intervention Type DRUG

Rosuvastatin 5mg

R20/E10

Rosuvastatin 20mg/ezetimibe 10mg

Group Type EXPERIMENTAL

Rosuvastatin/Ezetimibe

Intervention Type DRUG

Rosuvastatin 5mg

Interventions

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Rosuvastatin/Ezetimibe

Rosuvastatin 5mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hypercholesterolemic patient

Exclusion Criteria

* Has history of hypersensitivity to HMG-CoA reductase inhibitor and Ezetimibe
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IlDong Pharmaceutical Co Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tae Hoon Ahn

Role: PRINCIPAL_INVESTIGATOR

Gachon University Gil Medical Center

Locations

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Gil Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Min-Hee Kwon

Role: CONTACT

02-526-3379

Facility Contacts

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Tae Hoon Ahn

Role: primary

Other Identifiers

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ID-ROEZ-301

Identifier Type: -

Identifier Source: org_study_id

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