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Efficacy and Safety of Fenofibrate Added on to Atorvastatin Compared With Atorvastatin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01956201
Recruitment Status : Unknown
Verified February 2015 by Chong Kun Dang Pharmaceutical.
Recruitment status was:  Recruiting
First Posted : October 8, 2013
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of Atorvastatin and Fenofibrate compared with atorvastatin monotherapy in mixed hypercholesterolemic patients.

Condition or disease Intervention/treatment Phase
Mixed Hyperlipidemia Drug: Atorvastatin 20mg Drug: Fenofibrate 160mg Other: Placebo (Fenofibrate 160 mg) Phase 3

Detailed Description:

Multi center, randomized, double-blind, parallel-group, therapeutic confirmatory study

Primary Outcome Measure:

The mean percent change of Non-HDL Cholesterol [Time Frame: from baseline at week 8]

Secondary Outcome Measures:

The achievement rate of LDL-C<100mg/dl, Non-HDL-C<130mg/dl [Time Frame: from baseline at week 8] The mean percent change of LDL-C, HDL-C, TG, TC, Apo-AI, Apo-B [Time Frame: from baseline at week 4, 8] The mean percent change of Non-LDL-C/HDL-C, TC/HDL-C, LDL-C/HDL-C, Apo-B/Apo-AI [Time Frame: from baseline at week 4, 8] The mean percent change of Fibrinogen, hs-CRP [Time Frame: from baseline at week 4, 8] Safety evaluation [Time Frame: Treatment period and Extension period]

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 476 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Fenofibrate Added on to Atorvastatin Compared With Atorvastatin in Mixed Hypercholesterolemic Patient: Multi Center, Randomized, Double-blind, Parallel-group, Therapeutic Confirmatory Study.
Study Start Date : December 2013
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Atorvastatin 20mg, Fenofibrate 160mg
Atorvastatin 20mg, Fenofibrate 160mg: po, q.d.
Drug: Atorvastatin 20mg
[Atorvastatin Run-in Period] Take Atorvastatin 20mg 1 tablet once a day (after breakfast) [Treatment Period] Take Atrovastatin 20mg/Fenofibrate 160mg or Atorvastiatin 20mg/Placebo of Finofibrate 160mg 2 tablet once a day (after breakfast) [Extension Period] Take Atrovastatin 20mg, Fenofibrate 160mg 2 tablet once a day (after breakfast)
Other Name: Lipilou Tab.

Drug: Fenofibrate 160mg
Refer to Intervention Description of Atorvastatin 20mg

Active Comparator: Atorvastatin 20mg, Placebo
Atorvastatin 20mg, Placebo for Fenofibrate 160mg po, q.d.
Drug: Atorvastatin 20mg
[Atorvastatin Run-in Period] Take Atorvastatin 20mg 1 tablet once a day (after breakfast) [Treatment Period] Take Atrovastatin 20mg/Fenofibrate 160mg or Atorvastiatin 20mg/Placebo of Finofibrate 160mg 2 tablet once a day (after breakfast) [Extension Period] Take Atrovastatin 20mg, Fenofibrate 160mg 2 tablet once a day (after breakfast)
Other Name: Lipilou Tab.

Other: Placebo (Fenofibrate 160 mg)
Refer to Intervention Description of Atorvastatin 20mg
Other Name: Placebo




Primary Outcome Measures :
  1. The mean percent change of Non-HDL Cholesterol [ Time Frame: from baseline at week 8 ]

Secondary Outcome Measures :
  1. The achievement rate of LDL-C<100mg/dl, Non-HDL-C<130mg/dl [ Time Frame: from baseline at week 8 ]
  2. The mean percent change of LDL-C, HDL-C, TG, TC, Apo-AI, Apo-B [ Time Frame: from baseline at week 4, 8 ]
  3. The mean percent change of Non-LDL-C/HDL-C, TC/HDL-C, LDL-C/HDL-C, Apo-B/Apo-AI [ Time Frame: from baseline at week 4, 8 ]
  4. The mean percent change of Fibrinogen, hs-CRP [ Time Frame: from baseline at week 4, 8 ]
  5. Safety evaluation (Physical examination, Vital sign, Laboratory, AE etc.) [ Time Frame: Treatment period (8 weeks) and Extension period (16 weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >19 years old
  • High risk patient to Coronary Heart Disease (applied to 1 or more CHD risk factor listed below)

    1. Patient with Coronary Heart Disease
    2. Patient with carotid artery disease, peripheral blood vessel disease, abdominal aneurysm
    3. Patient with diabetes(HbA1C≤9.0%)
    4. 10-year risk of CHD >20%(by Framingham 10-year risk score calculation)
  • At Visit 1(Screening)

    1. 100mg/dl≥LDL-C, 150mg/dl≤TG≤500mg/dl

      • 4weeks of Atorvastatin 20mg monotherapy run-in period
    2. LDL-C<100mg/dl, 150mg/dl≤TG≤500mg/dl

      • If treated with Atorvastatin 20mg monotherapy 4weeks prior to this study
  • At Visit 2(After 4weeks of Atorvastatin monotherapy run-in period)

    • LDL<100mg/dl, 150mg/dl≤TG≤500mg/dl

Exclusion Criteria:

  • Patients with acute artery disease within 3 months
  • Patients with congestive heart failure(NYHA class III~IV) or uncontrolled arrhythmia within 6 months
  • Patients with uncontrolled hypertension(SBP>160mmHg or DBP>95mmHg)
  • TSH>1.5X ULN
  • Patients with myopathy, rhabdomyolysis or CK>2X ULN
  • Hypersensitive to Atorvastatin and/or Fenofibrate or had photoallergy or phototoxicity during fibrate and/or ketoprofen treatment
  • Serum Creatinine>2.5mg/dl, AST or ALT > 2X ULN
  • History of drug or alcohol abuse within 6 months
  • History of GI tract surgery or disability to drug absorption
  • Women with pregnant, breast-feeding
  • Patients with gallbladder disease
  • Patients with biliary cirrhosis
  • Patients with pancreatitis(acute pancreatitis is excluded due to severe hypertriglyceridemia)
  • Patients treated with any investigational drugs within 4 weeks at the time consents are obtained
  • History of malignant tumor including leukemia, lymphoma within 5 years
  • Patients must be treated with medications prohibited for concomitant use during study period
  • Not eligible to participate for the study at the discretion of investigator

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): NCT01956201


Contacts
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Contact: Hyun-Kyung Oh 82-2-2194-0469 hkoh@ckdpharm.com

Locations
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Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: MoonKyu Lee, M.D. , Ph.D. Samsung Medical Center - Seoul

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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01956201    
Other Study ID Numbers: 146MHL13011
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Hyperlipidemia, Familial Combined
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Atorvastatin
Fenofibrate
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors