NCT02251847

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

September 29, 2014

Status Verified

September 1, 2014

Enrollment Period

1 year

First QC Date

September 25, 2014

Last Update Submit

September 25, 2014

Conditions

Hypercholesterolemia

Keywords

cholesterol

Outcome Measures

Primary Outcomes (1)

  • Percent change from baseline to 8 week in LDL-Cholesterol

    baseline and 8 week

Secondary Outcomes (1)

  • Percent change from baseline to 4 week in LDL-Cholesterol

    baseline and 4 week

Study Arms (6)

R5

ACTIVE COMPARATOR

Rosuvastatin 5mg

Drug: Rosuvastatin/Ezetimibe

R10

ACTIVE COMPARATOR

Rosuvastatin 10mg

Drug: Rosuvastatin/Ezetimibe

R20

ACTIVE COMPARATOR

Rosuvastatin 20mg

Drug: Rosuvastatin/Ezetimibe

R5/E10

EXPERIMENTAL

Rosuvastatin 5mg/ezetimibe 10mg

Drug: Rosuvastatin/Ezetimibe

R10/E10

EXPERIMENTAL

Rosuvastatin 10mg/ezetimibe 10mg

Drug: Rosuvastatin/Ezetimibe

R20/E10

EXPERIMENTAL

Rosuvastatin 20mg/ezetimibe 10mg

Drug: Rosuvastatin/Ezetimibe

Interventions

Rosuvastatin/EzetimibeDRUG

Rosuvastatin 5mg

R10R10/E10R20R20/E10R5R5/E10

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypercholesterolemic patient

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gil Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Rosuvastatin CalciumEzetimibe

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAzetidinesAzetines

Study Officials

  • Tae Hoon Ahn

    Gachon University Gil Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Min-Hee Kwon

CONTACT

02-526-3379minhee@ildong.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2014

First Posted

September 29, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2015

Last Updated

September 29, 2014

Record last verified: 2014-09

Locations

KR(1)