AzTrials
AzTrials

Primary HypercholesterolemiaPhase 3NCT03571087

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

A Phase 3 study testing HL140 5/10, HL140 10/10 and HL140 20/10 in people with Primary Hypercholesterolemia, run by Hanlim Pharm. Co., Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 19 years and older
Conditions the study is for
Primary Hypercholesterolemia
What is being tested?
HL140 5/10, HL140 10/10 and HL140 20/10
Could I receive a placebo?
No, everyone receives an active treatment
How many people
374 participants
Where
No sites listed yet
Study dates
Sep 2014to Sep 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 20Show fewer
  • 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
  • Female subjects of childbearing potential who disagree with the contraceptive methods(surgical sterilization, intrauterine device or condoms)
  • Pregnant or breast-feeding
  • Patients who have a drug or alcohol abuse or are being treated for psychological disorder
  • Patients who were treated with other investigational drug within 12 weeks prior to screening
  • Other patients who are inappropriate to participate in the study considered by the investigator or other study staffs

About this study

Official title: 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

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

Read the detailed description

The purpose of this study is to demonstrate that the efficacy of combination drug of rosuvastatin/ezetimibe is superior to single rosuvastatin drug and to confirm the safety of combination drug of rosuvastatin/ezetimibe

Being tested
HL140 5/10, HL140 10/10, HL140 20/10, Rosuvastatin 5mg → HL140 5/10, Rosuvastatin 10mg → HL140 10/10

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 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 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

  • 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 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 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
Study groups in NCT03571087
Study groupRoleWhat they receive
HL140 5/10ExperimentalTreatment(W0~W8), Extension(W9~W20): : 6Tab./q.d. HL140 5/10(Rosuvastatin5mg/Ezetimibe10mg)
Receives: Drug: HL140 5/10
HL140 10/10ExperimentalTreatment(W0~W8), Extension(W9~W20): : 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg)
Receives: Drug: HL140 10/10
HL140 20/10ExperimentalTreatment(W0~W8), Extension(W9~W20): : 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg)
Receives: Drug: HL140 20/10
Rosuvastatin 5mg → HL140 5/10Experimental1. Treatment(W0~W8): 6Tab./q.d. Rosuvastatin 5mg 2. Extension period(W9~W20): 6Tab./q.d. HL140 5/10(Rosuvastatin5mg/Ezetimibe10mg)
Receives: Drug: Rosuvastatin 5mg → HL140 5/10
Rosuvastatin 10mg → HL140 10/10Experimental1. Treatment(W0~W8): 6Tab./q.d. Rosuvastatin 10mg 2. Extension period(W9~W20): 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg)
Receives: Drug: Rosuvastatin 10mg → HL140 10/10
Rosuvastatin 20mg → HL140 20/10Experimental1. Treatment(W0~W8): 6Tab./q.d. Rosuvastatin 20mg 2. Extension period(W9~W20): 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg)
Receives: Drug: Rosuvastatin 20mg → HL140 20/10

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage change in LDL-Cholesterol from baseline

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

    Measured: Week 8

Secondary outcomes (10)

  1. Percentage change in LDL-Cholesterol from baseline

    Percentage change(%) in LDL-Cholesterol from baseline at week 4

    Measured: Week 4

  2. Percentage change in TG from baseline

    Percentage change(%) in TG from baseline at week 4 and week 8

    Measured: Week 4, Week 8

  3. Percentage change in TC from baseline

    Percentage change(%) in TC from baseline at week 4 and week 8

    Measured: Week 4, Week 8

  4. Percentage of change in non-HDL-Cholesterol

    Percentage change(%) in non-HDL-Cholesterol from baseline at week 4 and week 8

    Measured: Week 4, Week 8

  5. Percentage of change in HDL-Cholesterol

    Percentage change(%) in HDL-Cholesterol from baseline at week 4 and week 8

    Measured: Week 4, Week 8

  6. Percentage of change weeks in Apo A-I

    Percentage change(%) in Apo A-I from baseline at week 4 and week 8

    Measured: Week 4, Week 8

  7. Percentage of change in Apo B

    Percentage change(%) in Apo B from baseline at week 4 and week 8

    Measured: Week 4, Week 8

  8. Percentage of change in Lipoprotein(a)

    Percentage change(%) in Lipoprotein(a) from baseline at week 4 and week 8

    Measured: Week 4, Week 8

  9. The rate of change in hs-CRP

    Percentage change(%) in hs-CRP from baseline at week 4 and week 8

    Measured: Week 4, Week 8

  10. Percentage of patients reached treatment goals according to NCEP ATP III Guideline

    Percentage(%) of patients reached treatment goal, by NCEP ATP III guideline, at week 4 and week 8

    Measured: Week 4, Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2018
  2. Study startSep 2014
  3. Primary completionAug 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
374 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03571087
Sponsor's protocol ID
HL_HL140_301
Status last verified
Jun 2018
First submitted
17 Jun 2018
Last updated
14 Aug 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HL140 5/10, HL140 10/10 and HL140 20/10 in people with Primary Hypercholesterolemia, run by Hanlim Pharm. Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change in LDL-Cholesterol from baseline (time frame: Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03571087.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in