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

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ClinicalTrials.gov Identifier: NCT02166593
Recruitment Status : Completed
First Posted : June 18, 2014
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Yooyoung Pharmaceutical Co., Ltd.

Brief 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. 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

Condition or disease Intervention/treatment Phase
Combined Dyslipidemia Drug: Pravastatin40mg/Fenofibrate160mg Drug: Atorvastatin Sodium 10mg Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : May 2014
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018


Arm Intervention/treatment
Experimental: Pravastatin 40mg/Fenofibrate160mg
Pravastatin (40mg/day) Fenofibrate (160mg/day)
Drug: Pravastatin40mg/Fenofibrate160mg
Pravafenix(Pravastatin40mg/Fenofibrate160mg)
Other Name: Pravafenix(Pravastatin40mg/Fenofibrate160mg)

Drug: Atorvastatin Sodium 10mg
Lipitor 10mg(Atorvastatin Sodium)
Other Name: Lipitor 10mg(Atorvastatin Sodium)

Active Comparator: Atorvastatin Sodium
Atorvastatin Sodium (10mg/day)
Drug: Pravastatin40mg/Fenofibrate160mg
Pravafenix(Pravastatin40mg/Fenofibrate160mg)
Other Name: Pravafenix(Pravastatin40mg/Fenofibrate160mg)

Drug: Atorvastatin Sodium 10mg
Lipitor 10mg(Atorvastatin Sodium)
Other Name: Lipitor 10mg(Atorvastatin Sodium)




Primary Outcome Measures :
  1. Percent change (%) from baseline in Non-HDL-C [ Time Frame: at Week 8 ]
    Percent change (%) from baseline at Week 8 in Non-HDL-C


Secondary Outcome Measures :
  1. Percent change (%) from baseline in Non-HDL-C [ Time Frame: Week 4 ]
    Percent change (%) from baseline at Week 4 in Non-HDL-C

  2. ◦Percent change (%) from baseline at Week 4 and Week 8 in TG [ Time Frame: Week 4 and Week 8 ]
    Percent change (%) from baseline at Week 4 and Week 8 in TG

  3. Percent change (%) from baseline at Week 4 and Week 8 in TC [ Time Frame: Week 4 and Week 8 ]
    Percent change (%) from baseline at Week 4 and Week 8 in TC

  4. Percent change (%) from baseline at Week 4 and Week 8 in LDL-C [ Time Frame: Week 4 and Week 8 ]
    Percent change (%) from baseline at Week 4 and Week 8 in LDL-C

  5. Percent change (%) from baseline at Week 4 and Week 8 in HDL-C [ Time Frame: Week 4 and Week 8 ]
    Percent change (%) from baseline at Week 4 and Week 8 in HDL-C

  6. Percent change (%) from baseline at Week 4 and Week 8 in Apo A-I [ Time Frame: Week 4 and Week 8 ]
    Percent change (%) from baseline at Week 4 and Week 8 in Apo A-I

  7. Percent change (%) from baseline at Week 4 and Week 8 in Apo B [ Time Frame: Week 4 and Week ]
    Percent change (%) from baseline at Week 4 and Week 8 in Apo B



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Screening visit (Pre-Study Visit :D-28)

  1. Men and women at the age ≥ 20 and < 80
  2. 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
    • Patients with abdominal aneurysm, or
    • Patients with diabetes mellitus, or
    • Patients at a more than 20% 10-year risk of coronary heart disease, or
  3. LDL-C < 160mg/dL at screening
  4. Fasting triglyceride (TG) level ≥ 150mg/dL and < 500mg/dL at screening
  5. HDL-C level <40mg/dL (Male Patient), <50mg/dL(Female Patient)
  6. Voluntary written informed consent to study participation

Secondary visit (Visit 2 (D0))

  1. LDL-C < 100mg/dL after the 4-week atorvastatin run-in period
  2. Fasting TG level ≥ 150mg/dL and < 500mg/dL after the 4-week atorvastatin run-in period
  3. HDL-C level <40mg/dL (Male Patient), <50mg/dL(Female Patient)

Exclusion Criteria:

  1. 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)
  2. Revascularzation procedure or aortic aneurysm operation within 6 months prior to study participation
  3. 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
  4. Acute or chronic pancreatitis due to hypertriglyceridemia
  5. Cardiovascular, hepatic, neurological, endocrine, or other serious systemic disease that may affect the study conduct or interpretations of the study results
  6. Known positive serum tests to human immunodeficiency virus (HIV) Antibody I or II
  7. Diagnosis of cancer within the past 2 years (except successfully treated basal cell carcinoma and squamous cell carcinoma)
  8. 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.)
  9. 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
  10. Moderate to severe renal impairment (GFR<60ml/min) at screening
  11. 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.)
  12. Uncontrolled hypothyroidism
  13. Uncontrolled diabetes mellitus (HbA1c>8.5%)
  14. Hyperlipidemia Class I, IIa, IV, or V
  15. Requiring insulin treatment for diabetes mellitus
  16. Allergies or hypersensitivity reactions to the study drug
  17. Patients known to have, or suspected of having a history of drug or alcohol abuse within the past 2 years
  18. Confirmed pregnant or lactating women at screening
  19. 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.
  20. Having participated in another clinical trial within 1 month prior to screening
  21. History of photoallergic or phototoxic reactions during treatment with fibrates or ketoprofen
  22. Biliary disease
  23. Interstitial pulmonary disease
  24. Other patients considered by the principal investigator or sub-investigator inappropriate for study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02166593


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yooyoung Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Hyo-Soo Kim, M.D. Seoul National University Hospital, Department of Internal Medicine
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Responsible Party: Yooyoung Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02166593    
Other Study ID Numbers: YYP-Pravafenix-C31301
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Pravastatin
Fenofibrate
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors