NCT03571087|CompletedPhase 3

Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia

A Multi Center, Randomized, Double-blind, Parallel, Factorial Design, Therapeutic Phase III Study to Evaluate the Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia

Hanlim Pharm. Co., Ltd.ClinicalTrials.gov

Compare

1 other identifier

HL_HL140_301

Study Type

interventional

Target

374

Locations

0 countries

Sites

N/A

Timeline

RegisteredJun 2018

StartedSep 2014

CompletionSep 2015

Brief Summary

The purpose of this study is to evaluate efficacy and safety of HL140 in patients with primary hypercholesterolemia.

Trial Health

100

On Track

Trial Health Score

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

Enrollment

374

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Sep 2014

Shorter than P25 for phase_3

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

1 year study duration

Study Start

First participant enrolled

September 1, 2014

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed

2.8 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2018

Completed

10 days until next milestone

First Posted

Study publicly available on registry

June 27, 2018

Completed

Last Updated

August 14, 2018

Status Verified

June 1, 2018

Enrollment Period

11 months

First QC Date

June 17, 2018

Last Update Submit

August 12, 2018

Conditions

Primary Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

Percentage change in LDL-Cholesterol from baseline
Percentage change(%) in LDL-Cholesterol from baseline at week 8
Week 8

Secondary Outcomes (10)

Percentage change in LDL-Cholesterol from baseline
Week 4
Percentage change in TG from baseline
Week 4, Week 8
Percentage change in TC from baseline
Week 4, Week 8
Percentage of change in non-HDL-Cholesterol
Week 4, Week 8
Percentage of change in HDL-Cholesterol
Week 4, Week 8
+5 more secondary outcomes

Study Arms (6)

HL140 5/10

EXPERIMENTAL

Treatment(W0\~W8), Extension(W9\~W20): : 6Tab./q.d. HL140 5/10(Rosuvastatin5mg/Ezetimibe10mg)

Drug: HL140 5/10

HL140 10/10

EXPERIMENTAL

Treatment(W0\~W8), Extension(W9\~W20): : 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg)

Drug: HL140 10/10

HL140 20/10

EXPERIMENTAL

Treatment(W0\~W8), Extension(W9\~W20): : 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg)

Drug: HL140 20/10

Rosuvastatin 5mg → HL140 5/10

EXPERIMENTAL

1. Treatment(W0\~W8): 6Tab./q.d. Rosuvastatin 5mg 2. Extension period(W9\~W20): 6Tab./q.d. HL140 5/10(Rosuvastatin5mg/Ezetimibe10mg)

Drug: Rosuvastatin 5mg → HL140 5/10

Rosuvastatin 10mg → HL140 10/10

EXPERIMENTAL

1. Treatment(W0\~W8): 6Tab./q.d. Rosuvastatin 10mg 2. Extension period(W9\~W20): 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg)

Drug: Rosuvastatin 10mg → HL140 10/10

Rosuvastatin 20mg → HL140 20/10

EXPERIMENTAL

1. Treatment(W0\~W8): 6Tab./q.d. Rosuvastatin 20mg 2. Extension period(W9\~W20): 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg)

Drug: Rosuvastatin 20mg → HL140 20/10

Interventions

HL140 5/10DRUG

1\) Treatment(W0\~W8), Extension(W9\~W20): 6Tab./q.d. HL140 5/10(Rosuvastatin5mg/Ezetimibe10mg) : ●♤♡□△◇ ●: HL140 5/10mg, ♤: HL140 10/10mg placebo, ♡: HL140 20/10mg placebo, □: Crestor Tab.5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo

HL140 5/10

HL140 10/10DRUG

1\) Treatment(W0\~W8), Extension(W9\~W20): 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg) : ○♠♡□△◇ ○: HL140 5/10mg placebo, ♠: HL140 10/10mg, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo

HL140 10/10

HL140 20/10DRUG

1\) Treatment(W0\~W8), Extension(W9\~W20): 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg) : ○♤♥□△◇ ○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo, ♥: HL140 20/10mg, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo

HL140 20/10

Rosuvastatin 5mg → HL140 5/10DRUG

1. Treatment(W0\~W8): 6Tab./q.d. Rosuvastatin 5mg : ○♤♡■△◇ ○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo,♡: HL140 20/10mg placebo, ■: Crestor Tab. 5mg, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo 2. Extension period(W9\~W20): 6Tab./q.d. HL1405/10(Rosuvastatin5mg/Ezetimibe10mg) : ●♤♡□△◇ * HL140 5/10mg, ♤: HL140 10/10mg placebo, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo

Rosuvastatin 5mg → HL140 5/10

Rosuvastatin 10mg → HL140 10/10DRUG

1. Treatment(W0\~W8): 6Tab./q.d. Rosuvastatin 10mg : ○♤♡□▲◇ ○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, ▲: Crestor Tab. 10mg, ◇: Crestor Tab. 20mg placebo 2. Extension period(W9\~W20): 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg) : ○♠♡□△◇ * HL140 5/10mg placebo, ♠: HL140 10/10mg, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo

Rosuvastatin 10mg → HL140 10/10

Rosuvastatin 20mg → HL140 20/10DRUG

1. Treatment(W0\~W8): 6Tab./q.d.Rosuvastatin 20mg : ○♤♡□△◆ ○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◆: Crestor Tab. 20mg 2. Extension period(W9\~W20): 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg) : ○♤♥□△◇ ○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo, ♥: HL140 20/10mg, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo

Rosuvastatin 20mg → HL140 20/10

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Aged over 19 years
Signed informed consent form
At visit 1 and visit 2, LDL-Cholesterol ≤ 250mg/dL and Triglyceride ≤ 400mg/dL

You may not qualify if:

At visit 1, BMI ≥ 30kg/㎡
Has a history of myopathy or rhabdomyolysis cased by statin treatment, hereditary myopathy or family history and hypersensitivity to statin(HMG-CoA reductase inhibitor) and component of ezetimibe
Has a Severe renal disorder(Ccr \<30mL/min) or nephrotic syndrome
Creatine Kinase \> 5 x upper limit of normal
ALT or AST \> 3 x upper limit of normal
Has a activity/chronic hepatic disease or HIV-positive
Has a endocrine or metabolic diseases known to affect the serum phospholipid or protein
Uncontrolled diabetes mellitus(HbA1c ≥9%)
Hypothyroidism (TSH \> 1.5 x upper limit of normal rate at the screening )
Uncontrolled hypertension (SBP ≥180mmHg or DBP ≥110mmHg)
Has a acute arteriopathy(history of unstable angina, cardiac infarction, transient ischemic stroke, cerebrovascular disease, coronary artery bypass, coronary intervention within 12 weeks prior to screening)
Severe heart failure (NYHA Class III or IV)
Has a drug absorption disorder by gastrointestinal surgery or gastrointestinal disorder
History of malignant tumor including myelogenous and lymphoma within 5 years (Participation is possible, if the tumor has not recurred for more than 5 years)
Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
+5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Hanlim Pharm. Co., Ltd.lead

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

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

Study Officials

Kisik Kim
The Catholic University of Korea, Dagu St. Mary's Hospital
STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

June 17, 2018

First Posted

June 27, 2018

Study Start

September 1, 2014

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

August 14, 2018

Record last verified: 2018-06

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (6)

HL140 5/10

HL140 10/10

HL140 20/10

Rosuvastatin 5mg → HL140 5/10

Rosuvastatin 10mg → HL140 10/10

Rosuvastatin 20mg → HL140 20/10

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates