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

NCT02166593 | Completed Phase 3 DMC

• 1 other identifier: YYP-Pravafenix-C31301
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Target disease : Patients with combined dyslipidemia with adequately controlled LDL-C but inadequately controlled triglyceride level by atorvastatin monotherapy
2. 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. 3.Phase and design : A multicenter, double blind, randomized, active controlled, parallel-design, Phase 3 study
4. 4.Duration of study : 12 months from the IRB approval date
5. 5.Duration of administration : 4-week single blind run-in period plus 8-week double blind treatment period

Conditions

Combined Dyslipidemia

Outcome Measures

Primary Outcomes (1)

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

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

  at Week 8

Secondary Outcomes (7)

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

  Week 4

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

  Week 4 and Week 8

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

  Week 4 and Week 8

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

  Week 4 and Week 8

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

  Week 4 and Week 8

Study Arms (2)

Pravastatin 40mg/Fenofibrate160mg

EXPERIMENTAL

Pravastatin (40mg/day) Fenofibrate (160mg/day)

Drug: Pravastatin40mg/Fenofibrate160mg; Drug: Atorvastatin Sodium 10mg

Atorvastatin Sodium

ACTIVE COMPARATOR

Atorvastatin Sodium (10mg/day)

Drug: Pravastatin40mg/Fenofibrate160mg; Drug: Atorvastatin Sodium 10mg

Interventions

Pravastatin40mg/Fenofibrate160mg DRUG

Pravafenix(Pravastatin40mg/Fenofibrate160mg)

Also known as: Pravafenix(Pravastatin40mg/Fenofibrate160mg)

Atorvastatin Sodium; Pravastatin 40mg/Fenofibrate160mg

Atorvastatin Sodium 10mg DRUG

Lipitor 10mg(Atorvastatin Sodium)

Also known as: Lipitor 10mg(Atorvastatin Sodium)

Atorvastatin Sodium; Pravastatin 40mg/Fenofibrate160mg

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Yooyoung Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Hyo-Soo Kim, M.D.

  Seoul National University Hospital, Department of Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: June 18, 2014
• Study Start: May 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)