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Complex-dyslipidemiaPhase 3NCT03618797

A Clinical Trial to Evaluate the Efficacy and Safety of Pitavastatin/Fenofibrate in Complex-dyslipidemia

A Phase 3 study of Complex-dyslipidemia, 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
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of Pitavastatin versus Pitavastatin/Fenofibrate in complex-dyslipidemia patients. Read more about this study

Who is it for?
Ages 19 to 80 years
Conditions the study is for
Complex-dyslipidemia
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
347 participants
Where
No sites listed yet
Study dates
Nov 2015to May 2018
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • High risk patient to Coronary Heart Disease
  • At visit 1(Screening)
  • If treated with Pitavastatin 2mg monotherapy 4 weeks prior to this study : LDL-C<100mg/dL and 150mg/dL≤TG<500mg/dL, randomize without run-in period
  • If non treated with Pitavastatin 2mg monotherapy 4 weeks prior to this study : LDL-C≥100mg/dL and 150mg/dL≤TG<500mg/dL, treatment of Pitavastatin 2mg for 4 weeks(run-in period)
  • LDL-C<100mg/dL and 150mg/dL≤TG<500mg/dL after 4 weeks of Pitavastatin 2mg monotherapy

Who cannot join

  • Subject with acute artery disease
  • Subject with congestive heart failure(NYHA class III~IV) or uncontrolled arrhythmia
  • Secondary or iatrogenic dyslipidemia caused by hypothyroidism, nephrotic syndrome etc.
  • AST or ALT > 2XULN, Serum Creatinine > 2.5mg/dL, Creatinine phosphokinase > 2XULN
  • Subject with gall bladder disease or pancreatitis
  • Uncontrolled hypertension
Show all 9Show fewer
  • Endocrine or metabolic disease affected on serum lipid or liprotein
  • Subject with medical history of myopathy or rhabdomyolysis caused by Statin treatment, hereditary myopathy or family history
  • Not eligible to participate for the study at the discretion of investigator

About this study

Official title: A Multicenter, Randomized, Double-blinded, Parallel, Therapeutic Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of Pitavastatin Versus Pitavastatin/Fenofibrate in Complex-dyslipidemia Patients

The purpose of this study is to evaluate the efficacy and safety of Pitavastatin versus Pitavastatin/Fenofibrate in complex-dyslipidemia patients.

Read the detailed description

The purpose of this study is to demonstrate the efficacy of the Pitavastatin/Fenofibrate in complex-dyslipidemia patients by the reduction of non-HDL-Cholesterol levels compared with Pitavastatin.

Being tested
HL-PIF cap.160/2mg + Placebo, Livalo tab. 2mg + Placebo

What participants receive

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

  • HL-PIF cap.160/2mg + PlaceboDrug

    Also called Fenofibrate 160mg/Pitavastatin Ca 2mg

    Fenofibrate pellet (as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg

  • Livalo tab. 2mg + PlaceboDrug

    Also called Pitavastatin Ca 2mg

    Pitavastatin ca 2mg

Study groups in NCT03618797
Study groupRoleWhat they receive
HL-PIF cap.160/2mg + PlaceboExperimental* Fenofibrate pellet (as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg * once a day
Receives: Drug: HL-PIF cap.160/2mg + Placebo
Livalo tab. 2mg + PlaceboActive comparator* Pitavastatin ca 2mg * once a day
Receives: Drug: Livalo tab. 2mg + Placebo

What is being measured

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

  1. The mean percentage change of Non-HDL Cholesterol

    Change rate of Non-HDL-C after 8 weeks compared to baseline (%)

    Measured: from baseline at week 8

Secondary outcomes (15)

  1. The mean percentage change of Non-HDL Cholesterol

    Change rate of Non-HDL-C after 4 weeks compared to baseline (%)

    Measured: from baseline at week 4

  2. The mean percentage change of LDL-C

    Change rate of LDL-C after 4 and 8 weeks compared to baseline (%)

    Measured: from baseline at week 4,8

  3. The mean percentage change of HDL-C

    Change rate of HDL-C after 4 and 8 weeks compared to baseline (%)

    Measured: from baseline at week 4,8

  4. The mean percentage change of LDL-C/HDL-C

    Change rate of LDL-C/HDL-C after 4 and 8 weeks compared to baseline (%)

    Measured: from baseline at week 4,8

  5. The mean percentage change of TC/HDL-C

    Change rate of TC/HDL-C after 4 and 8 weeks compared to baseline (%)

    Measured: from baseline at week 4,8

  6. The mean percentage change of non-HDL-C/HDL-C

    Change rate of non-HDL-C/HDL-C after 4 and 8 weeks compared to baseline (%)

    Measured: from baseline at week 4,8

  7. The mean percentage change of VLDL-C

    Change rate of VLDL-C after 4 and 8 weeks compared to baseline (%)

    Measured: from baseline at week 4,8

  8. The mean percentage change of TG

    Change rate of TG after 4 and 8 weeks compared to baseline (%)

    Measured: from baseline at week 4,8

  9. The mean percentage change of TC

    Change rate of TC after 4 and 8 weeks compared to baseline (%)

    Measured: from baseline at week 4,8

  10. The mean percentage change of Apo Al

    Change rate of Apo Al after 4 and 8 weeks compared to baseline (%)

    Measured: from baseline at week 4,8

  11. The mean percentage change of Apo B

    Change rate of Apo B change after 4 and 8 weeks compared to baseline (%)

    Measured: from baseline at week 4,8

  12. The mean percentage change of Apo Al/Apo B

    Change rate of Apo Al/Apo B after 4 and 8 weeks compared to baseline (%)

    Measured: from baseline at week 4,8

  13. The mean percentage change of fibrinogen

    Change rate of fibrinogen after 4 and 8 weeks compared to baseline (%)

    Measured: from baseline at week 4,8

  14. The mean percentage change of hs-CRP

    Change rate of hs-CRP after 4 and 8 weeks compared to baseline (%)

    Measured: from baseline at week 4,8

  15. Achievement rate(%) of treatment goals after 4 weeks and 8 weeks

    LDL-C<100mg/dL \& non-HDL-C <130mg/dL

    Measured: from baseline at week 4,8

Timeline

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

  1. First posted7 Aug 2018
  2. Study startNov 2015
  3. Primary completionJan 2018
  4. Study completionMay 2018

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
347 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03618797
Sponsor's protocol ID
HL-PIF-301
Status last verified
Aug 2018
First submitted
1 Aug 2018
Last updated
7 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ihm SH, Chung WB, Lee JM, Hwang BH, Yoo KD, Her SH, Song WH, Chae IH, Park TH, Kim JH, Jeon DW, Cho BR, Kang SH, Park SD, Lee JB, Woo JT, Lee BW, Han KA, Won KH, Kim HS, Yu JM, Chung CH, Kim HJ, Cho HC, Seung KB. Efficacy and Tolerability of Pitavastatin Versus Pitavastatin/Fenofibrate in High-risk Korean Patients with Mixed Dyslipidemia: A Multicenter, Randomized, Double-blinded, Parallel, Therapeutic Confirmatory Clinical Trial. Clin Ther. 2020 Oct;42(10):2021-2035.e3. doi: 10.1016/j.clinthera.2020.08.002. Epub 2020 Sep 2.

    PubMed 32891418

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of Complex-dyslipidemia, 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 5 inclusion and 9 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 7 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?

The mean percentage change of Non-HDL Cholesterol (time frame: from baseline at 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 NCT03618797, which also lists 1 linked publication.

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 7 Aug 2018.

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