Phase III Study of Rosuvastatin and Fenofibrate Versus Ro... | NCT02262143

Studies
Phase III Study of Rosuvastatin and Fenofibrate Versus Rosuvastatin in Mixed Dyslipidemia

NCT02262143

Sponsor

IlDong Pharmaceutical Co Ltd

Status

Completed

Last Update Posted

Aug 24, 2018Actual

Enrollment

362Actual

Phase

Phase 3

Conditions

Mixed Dyslipidemias

Interventions

Rosuvastatin
Fenofibrate

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Oct 2016Actual

Completion Date

Jun 2017Actual

First Submitted Date

Oct 7, 2014

First Submission Date that Met QC Criteria

Oct 7, 2014

First Posted Date

Oct 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2018

Last Update Posted Date

Aug 24, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Efficacy and safety of combination therapy of rosuvastatin and fenofibrate versus rosuvastatin monotherapy in mixed dyslipidemia patients: A randomized, multi-center, double-blind, phase 3 study

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

362Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	Rosuvastatin 10 mg, Fenofibrate 160 mg	Drug: Rosuvastatin Drug: Fenofibrate
Comparator	Active Comparator	Rosuvastatin 10 mg	Drug: Rosuvastatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rosuvastatin	Drug	Rosuvastatin 10 mg, qd, po	Comparator Experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The mean percent change of Non-HDL Cholesterol		from baseline at week 8

Secondary Outcomes

Measure	Description	Time Frame
The mean change, percent change of Non-LDL-C		from baseline at week 4
The mean change of Non-LDL-C		from baseline at week 8
The mean percent change of LDL-C, HDL-C, VLDL-C, TG, TC, Apo-AI, Apo-B

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

19 ~ 80 years old
High risk patient to Coronary Heart Disease
At Visit 1(Screening)
1. Treated with Rosuvastatin 10mg monotherapy 4weeks prior to this study
2. 110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl
At Visit 2 (Baseline), 110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl

Exclusion Criteria:

AST or ALT > 2X ULN
Patients with uncontrolled hyperthyroidism (TSH>1.5X ULN)
Patients with uncontrolled diabetes (HbA1c ≥ 9%)
Patients with uncontrolled hypertension(SBP>160mmHg or DBP>95mmHg)
Patients with congestive heart failure(NYHA class III~IV) or uncontrolled arrhythmia within 6 months
Patients treated with any investigational drugs within 3 months at the time consents are obtained
Not eligible to participate for the study at the discretion of investigator

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeongtaeck Woo, M.D., Ph.D	Kyunghee University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ildong Pharm.		Seoul			South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D000068718	Rosuvastatin Calcium
D011345	Fenofibrate

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes

Browse Leaves

Not provided

Browse Branches

Not provided