NCT03949374

Brief Summary

This 8 weeks, prospective, single center, randomized, open-label, parallel-group, non-inferiority study was performed from October 2015 to April 2018. This study as designed to evaluate the efficacy and safety of 10mg of the generic formulation (rosuvastatin, ROVASRO®) compared to the reference formulation (rosuvastatin, CRESTOR®) in patients with primary hypercholesterolemia and complex dyslipidemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2015

Typical duration 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

October 23, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
Last Updated

May 14, 2019

Status Verified

May 1, 2019

Enrollment Period

2.5 years

First QC Date

May 3, 2019

Last Update Submit

May 13, 2019

Conditions

HypercholesterolemiaDyslipidemias

Outcome Measures

Primary Outcomes (2)

  • Percentage change in the level of LDL-C

    Percentage change in the level of low-density lipoprotein-cholesterol (LDL-C)(mg/dL) from baseline to week 8 of drug treatment.

    8 weeks after treatment

  • Target achievement rate in the level of LDL-C

    Target achievement rate in the level of LDL-C from baseline to week 8 of drug treatment The LDL-C targets were defined as \<70 mg/dL for the very high risk group, \<100 mg/dL for the high risk group, \<130 mg/dL for the moderate risk group, and \<160 mg/dL for the low risk group (Committee. KCJ 2016).

    8 weeks after treatment

Secondary Outcomes (6)

  • Change in biochemical parameters : total cholesterol (mg/dL)

    8 weeks after treatment

  • Change in biochemical parameters : triglyceride (mg/dL)

    8 weeks after treatment

  • Change in biochemical parameters : high-density lipoprotein-cholesterol(HDL-C)(mg/dL)

    8 weeks after treatment

  • Change in biochemical parameters : apolipoprotein B(mg/dL)

    8 weeks after treatment

  • Change in biochemical parameters : apolipoprotein A1(mg/dL)

    8 weeks after treatment

  • +1 more secondary outcomes

Study Arms (2)

10mg of the generic formulation (rosuvastatin, ROVASRO®)

ACTIVE COMPARATOR

Taking 10mg of the generic formulation (rosuvastatin, ROVASRO®)

Drug: ROVASRO, generic formulation of rosuvastatin

10mg of the reference formulation (rosuvastatin, CRESTOR®)

ACTIVE COMPARATOR

Taking 10mg of the reference formulation (rosuvastatin, CRESTOR®)

Drug: CRESTOR, reference formulation of rosuvastatin

Interventions

CRESTOR, reference formulation of rosuvastatinDRUG

Use of ROVASRO for hypercholesterolemia

10mg of the reference formulation (rosuvastatin, CRESTOR®)
ROVASRO, generic formulation of rosuvastatinDRUG

Use of CRESTOR for hypercholesterolemia

10mg of the generic formulation (rosuvastatin, ROVASRO®)

Eligibility Criteria

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

You may qualify if:

  • Individuals aged between 19 and 80 years old.
  • The following patients who belong to the low-risk group to the very-high risk group according to 2015 Korean guidelines for the management of dyslipidemia (Committee, KCJ 2016).
  • Very high risk group (coronary artery disease, ischemic stroke, peripheral vascular disease) were not receiving lipid-lowering agents (statins) within 4 weeks of the screening, regardless of LDL-C levels
  • High risk group (carotid artery disease, abnormal aneurysm, diabetes)\* : LDL-C ≥ 100 mg/dl
  • Moderate risk group (2 or more major risk factors)\* : LDL-C ≥ 130 mg/dl
  • Low risk group (less than 1 major risk factors)\* : LDL-C ≥ 160 mg/dl
  • If the patients taka a lipid-lowering agents (statin) within 4 weeks of screening, enrolled them after wash-out for 4 weeks or more.
  • Patients who voluntarily participated in the trial and obtained document consent.

You may not qualify if:

  • a history of acute arterial disease (patients with unstable angina myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft or percutaneous transluminal coronary angioplasty within 3 months prior to study enrollment)
  • uncontrolled hypertension (systolic blood pressure ≥180mmHg or diastolic blood pressure ≥100mmHg)
  • uncontrolled diabetes (hemoglobin A1c ≥9% or fasting glucose ≥160mg/dl)
  • uncontrolled thyroid dysfunction (thyroid stimulation hormone ≥1.5 times the upper limits of normal (ULN))
  • usage of antihyperlipidemic drugs (bile acid sequestrants, fibrates, niacin, etc.) within 4 weeks before enrollment
  • a history of myopathy, rhabdomyolysis or elevated serum creatinine kinase (CK) more than 2 times the ULN
  • chronic kidney disease (serum creatinine ≥2 times the ULN)
  • elevated liver enzymes (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2 times the ULN)
  • a history of drug or alcohol abuse
  • a history of gastrointestinal surgery or gastrointestinal tract disorders
  • hypersensitivity to the components of this drug
  • those who disagree with contraception
  • pregnancy and/or lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

Location

Related Publications (1)

  • Kim H, Lee CJ, Choi D, Kim BK, Kim IC, Kim JS, Ahn CM, Hong GR, Cho IJ, Shim CY, Lee SH. Lipid-Lowering Efficacy and Safety of a New Generic Rosuvastatin in Koreans: an 8-Week Randomized Comparative Study with a Proprietary Rosuvastatin. J Lipid Atheroscler. 2020 May;9(2):283-290. doi: 10.12997/jla.2020.9.2.283. Epub 2020 Mar 6.

    PMID: 32821737DERIVED

MeSH Terms

Conditions

HypercholesterolemiaDyslipidemias

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

HyperlipidemiasLipid 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
Model Details: 10mg of the generic formulation (rosuvastatin, ROVASRO®) versus 10mg of the reference formulation (rosuvastatin, CRESTOR®)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2019

First Posted

May 14, 2019

Study Start

October 23, 2015

Primary Completion

April 16, 2018

Study Completion

June 1, 2018

Last Updated

May 14, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)