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Combined DyslipidemiaPhase 3NCT02166593

Clinical Trial to Evaluate the Efficacy and Safety of Pravafenix Cap to Verify the Superiority Than Atorvastatin

A Phase 3 study testing Pravastatin40mg/Fenofibrate160mg and Atorvastatin Sodium 10mg in people with Combined Dyslipidemia, run by Yooyoung Pharmaceutical Co., Ltd. at 1 site in South Korea.

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

1. Target disease : Patients with combined dyslipidemia with adequately controlled LDL-C but inadequately controlled triglyceride level by atorvastatin monotherapy 2. Study objective : The objective of this study is to demonstrate that Pravafenix Cap. Read more about this study

Who is it for?
Ages 20 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Combined Dyslipidemia
What is being tested?
Pravastatin40mg/Fenofibrate160mg and Atorvastatin Sodium 10mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
302 participants
Where
1 siteSouth Korea
Study dates
May 2014to Jan 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 20 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Screening visit (Pre-Study Visit :D-28)
  • Men and women at the age ≥ 20 and < 80
  • Patients at a high risk of coronary heart disease according to the NCEP ATPIII guidelines
  • Patients with coronary artery disease, or
  • Patients with symptomatic carotid artery disease, or
  • Patients with peripheral vascular disease, or
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  • Patients with abdominal aneurysm, or
  • Patients with diabetes mellitus, or
  • Patients at a more than 20% 10-year risk of coronary heart disease, or
  • LDL-C < 160mg/dL at screening
  • Fasting triglyceride (TG) level ≥ 150mg/dL and < 500mg/dL at screening
  • HDL-C level <40mg/dL (Male Patient), <50mg/dL(Female Patient)
  • Voluntary written informed consent to study participation
  • Secondary visit (Visit 2 (D0))
  • LDL-C < 100mg/dL after the 4-week atorvastatin run-in period
  • Fasting TG level ≥ 150mg/dL and < 500mg/dL after the 4-week atorvastatin run-in period
  • HDL-C level <40mg/dL (Male Patient), <50mg/dL(Female Patient)

Who cannot join

  • Acute arterial disease (history of unstable angina pectoris, myocardial infarction, acute coronary syndrome, transient ischemic attack, cerebrovascular disease, coronary bypass, or coronary artery disease within 3 months prior to study participation)
  • Revascularzation procedure or aortic aneurysm operation within 6 months prior to study participation
  • Myopathy, history of rhabdomyolysis or myopathy due to statins or fibrates, or elevated CK level ≥ 5 x upper limit of normal (ULN) during the previous statin treatment
  • Acute or chronic pancreatitis due to hypertriglyceridemia
  • Cardiovascular, hepatic, neurological, endocrine, or other serious systemic disease that may affect the study conduct or interpretations of the study results
  • Known positive serum tests to human immunodeficiency virus (HIV) Antibody I or II
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  • Diagnosis of cancer within the past 2 years (except successfully treated basal cell carcinoma and squamous cell carcinoma)
  • Patients treated with prohibited concomitant medications during the study period or those for whom treatment with prohibited concomitant medications is considered inevitable (systemic or inhalant corticosteroids may be allowed during the study provided that the treatment is maintained at the same dose.)
  • Administration of or will be administered with periodic sex hormone therapies or oral contraceptives within 2 months prior to the screening visit or during the study participation
  • Moderate to severe renal impairment (GFR<60ml/min) at screening
  • Severe hepatic impairment with AST/ALT level > 3 x ULN at screening (biliary cirrhosis, active liver disease, or continued increases in transaminases by unknown causes (> 3 x ULN), etc.)
  • Uncontrolled hypothyroidism
  • Uncontrolled diabetes mellitus (HbA1c>8.5%)
  • Hyperlipidemia Class I, IIa, IV, or V
  • Requiring insulin treatment for diabetes mellitus
  • Allergies or hypersensitivity reactions to the study drug
  • Patients known to have, or suspected of having a history of drug or alcohol abuse within the past 2 years
  • Confirmed pregnant or lactating women at screening
  • Women of childbearing potential at screening and planning to become pregnant during the study. Women at the childbearing age who did not undergo surgical sterilization may participate in the study only if the pregnancy test is determined negative and should maintain effective contraceptive methods throughout the study period. Periodic abstinence (e.g., calendar method, ovulation method, symptothermal method, post-ovulation method) and self control are not considered to be acceptable contraceptive methods, and use of hormonal contraceptives is not allowed.
  • Having participated in another clinical trial within 1 month prior to screening
  • History of photoallergic or phototoxic reactions during treatment with fibrates or ketoprofen
  • Biliary disease
  • Interstitial pulmonary disease
  • Other patients considered by the principal investigator or sub-investigator inappropriate for study participation

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Study to Evaluate the Efficacy and Safety of Pravastatin/Fenofibrate Complex in Patients With Combined Dyslipidemia With Adequately Controlled LDL-C But Inadequately Controlled Triglyceride Level by Atorvastatin Monotherapy

  1. Target disease : Patients with combined dyslipidemia with adequately controlled LDL-C but inadequately controlled triglyceride level by atorvastatin monotherapy
  2. Study objective : The objective of this study is to demonstrate that Pravafenix Cap. is clinically superior to atorvastatin by evaluating a percent change in Non-HDL-C in each group after 8 weeks treatment with atorvastatin or Pravafenix Cap. (pravastatin sodium/fenofibrate) in patients with adequately controlled LDL-C but inadequately controlled triglyceride level by atorvastatin monotherapy in a multicenter, randomized, double blind setting.
  3. Phase and design : A multicenter, double blind, randomized, active controlled, parallel-design, Phase 3 study
  4. Duration of study : 12 months from the IRB approval date
  5. Duration of administration : 4-week single blind run-in period plus 8-week double blind treatment period
Read the detailed description

This study is to Evaluate the Efficacy and Safety of Pravastatin/Fenofibrate Complex in Patients With Combined Dyslipidemia With Adequately Controlled LDL-C But Inadequately Controlled Triglyceride Level by Atorvastatin Monotherapy. After administrating the atorvastatin or Pravafenix Cap. (pravastatin sodium/fenofibrate) for 8 weeks, evaluate the variation of the Non-HDL-C for each arm. Ultimatly verificaite the Pravafenix Cap. (pravastatin sodium/fenofibrate) have better effects than atorvastatin.

Being tested
Pravastatin40mg/Fenofibrate160mg, Atorvastatin Sodium 10mg

What participants receive

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

  • Pravastatin40mg/Fenofibrate160mgDrug

    Also called Pravafenix(Pravastatin40mg/Fenofibrate160mg)

    Pravafenix(Pravastatin40mg/Fenofibrate160mg)

  • Atorvastatin Sodium 10mgDrug

    Also called Lipitor 10mg(Atorvastatin Sodium)

    Lipitor 10mg(Atorvastatin Sodium)

Study groups in NCT02166593
Study groupRoleWhat they receive
Pravastatin 40mg/Fenofibrate160mgExperimentalPravastatin (40mg/day) Fenofibrate (160mg/day)
Receives: Drug: Pravastatin40mg/Fenofibrate160mg; Drug: Atorvastatin Sodium 10mg
Atorvastatin SodiumActive comparatorAtorvastatin Sodium (10mg/day)
Receives: Drug: Pravastatin40mg/Fenofibrate160mg; Drug: Atorvastatin Sodium 10mg

What is being measured

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

  1. Percent change (%) from baseline in Non-HDL-C

    Percent change (%) from baseline at Week 8 in Non-HDL-C

    Measured: at Week 8

Secondary outcomes (7)

  1. Percent change (%) from baseline in Non-HDL-C

    Percent change (%) from baseline at Week 4 in Non-HDL-C

    Measured: Week 4

  2. ◦Percent change (%) from baseline at Week 4 and Week 8 in TG

    Percent change (%) from baseline at Week 4 and Week 8 in TG

    Measured: Week 4 and Week 8

  3. Percent change (%) from baseline at Week 4 and Week 8 in TC

    Percent change (%) from baseline at Week 4 and Week 8 in TC

    Measured: Week 4 and Week 8

  4. Percent change (%) from baseline at Week 4 and Week 8 in LDL-C

    Percent change (%) from baseline at Week 4 and Week 8 in LDL-C

    Measured: Week 4 and Week 8

  5. Percent change (%) from baseline at Week 4 and Week 8 in HDL-C

    Percent change (%) from baseline at Week 4 and Week 8 in HDL-C

    Measured: Week 4 and Week 8

  6. Percent change (%) from baseline at Week 4 and Week 8 in Apo A-I

    Percent change (%) from baseline at Week 4 and Week 8 in Apo A-I

    Measured: Week 4 and Week 8

  7. Percent change (%) from baseline at Week 4 and Week 8 in Apo B

    Percent change (%) from baseline at Week 4 and Week 8 in Apo B

    Measured: Week 4 and Week

Timeline

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

  1. First posted18 Jun 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionJan 2018
  4. Study completionJan 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
Double blind
Who is masked
Participant, Investigator
Enrolment
302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02166593
Sponsor's protocol ID
YYP-Pravafenix-C31301
Status last verified
Sep 2018
First submitted
27 May 2014
Last updated
28 Sep 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pravastatin40mg/Fenofibrate160mg and Atorvastatin Sodium 10mg in people with Combined Dyslipidemia, run by Yooyoung Pharmaceutical Co., Ltd. at 1 site in South Korea.

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 17 inclusion and 24 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 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Percent change (%) from baseline in Non-HDL-C (time frame: 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 NCT02166593.

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 28 Sep 2018.

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