NCT02280590

Brief Summary

Comparison of the efficacy and safety of Cresnon® and Crestor® in patients with hyperlipidemia \- 8-week, active-controlled, open-label, randomized, parallelgroup, fixed-dose, noninferiority, multicenter, phase 4 design

Trial Health

80
On Track

Trial Health Score

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

Enrollment
223

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

July 7, 2015

Status Verified

July 1, 2015

Enrollment Period

9 months

First QC Date

October 29, 2014

Last Update Submit

July 2, 2015

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • The percent change in LDL-C

    After taken medication for 8 weeks

Secondary Outcomes (2)

  • The percent change in total cholesterol, Triglyceride, HDL-C, non-HDL-C, and non-HDL-C/HDL-C

    After taken medication for 8 weeks

  • The proportion of subjects reaching LDL-C targeted level in accordance with the treatment guidelines for dyslipidemia released by Korean Society of Lipidology and Atherosclerosis

    After taken medication for 8 weeks

Study Arms (2)

Cresnon®

EXPERIMENTAL

Rosuvastatin 10mg, tablet, q.d.

Drug: Rosuvastatin(Cresnon®)

Crestor®

ACTIVE COMPARATOR

Rosuvastatin 10mg, tablet, q.d.

Drug: Rosuvastatin(Crestor®)

Interventions

Rosuvastatin(Cresnon®)DRUG

10mg

Cresnon®
Rosuvastatin(Crestor®)DRUG

10mg

Crestor®

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 20
  • Persons who have not reached LDL-C targeted level in accordance with the treatment guidelines for dyslipidemia released by Korean Society of Lipidology and Atherosclerosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2014

First Posted

October 31, 2014

Study Start

September 1, 2014

Primary Completion

June 1, 2015

Last Updated

July 7, 2015

Record last verified: 2015-07

Locations

KR(1)