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
Information source: Yooyoung Pharmaceutical Co.,Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Combined Dyslipidemia
Intervention: Pravastatin40mg/Fenofibrate160mg (Drug); Atorvastatin Sodium 10mg (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Yooyoung Pharmaceutical Co.,Ltd. Official(s) and/or principal investigator(s): Hyo-Soo Kim, M.D., Principal Investigator, Affiliation: Seoul National University Hospital, Department of Internal Medicine
Overall contact: Min-Kyung Kwon, Manager, Email: mkkwon@yypharm.co.kr
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
Clinical Details
Official title: A Multicenter, Double Blind, Randomized, Active Controlled, Parallel-design, Phase 3 Study to Evaluate the Efficacy and Safety of Pravafenix Cap. (Pravastatin Sodium/Fenofibrate) in Patients With Combined Dyslipidemia With Adequately Controlled LDL-C But Inadequately Controlled Triglyceride Level by Atorvastatin Monotherapy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Percent change (%) from baseline in Non-HDL-C
Secondary outcome: Percent change (%) from baseline in Non-HDL-C◦Percent change (%) from baseline at Week 4 and Week 8 in TG Percent change (%) from baseline at Week 4 and Week 8 in TC Percent change (%) from baseline at Week 4 and Week 8 in LDL-C Percent change (%) from baseline at Week 4 and Week 8 in HDL-C 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 B
Eligibility
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Min-Kyung Kwon, Manager, Email: mkkwon@yypharm.co.kr
Seoul National University Hospital, Seoul, Korea, Republic of; Recruiting Phone: +82-2-2072-0694 Hyo-Soo Kim, M.D., Principal Investigator
Additional Information
Starting date: May 2014
Last updated: July 14, 2015
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