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Evaluate the Efficacy of Fenofibrate on Microalbuminuria

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. Identifier: NCT02314533
Recruitment Status : Unknown
Verified December 2014 by Guang Wang, Beijing Chao Yang Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 11, 2014
Last Update Posted : December 11, 2014
Information provided by (Responsible Party):
Guang Wang, Beijing Chao Yang Hospital

Brief Summary:
The investigators design this prospective, open-label, parallel, controlled study to investigate fenofibrate's effect on microalbuminuria reduction and serum creatinine on top of statin therapy in Chinese hypertriglyceridemic patients with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Microalbuminuria Drug: fenofibrate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open-label, Parallel, Controlled Study to Evaluate the Efficacy of Fenofibrate on Microalbuminuria in Hypertriglyceridemic Patients With Type 2 Diabetes on Top of Statin Therapy
Study Start Date : December 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Fenofibrate

Arm Intervention/treatment
Experimental: fenofibrate
Fenofibrate 200mg capsule will be administered orally with breakfast once daily according to the Chinese prescription information of Lipanthyl, while previous type and dose of statin will be administered in the evening.
Drug: fenofibrate
Fenofibrate (Lipanthyl®) 200mg capsule will be administered orally with breakfast once daily
Other Name: Lipanthyl

Primary Outcome Measures :
  1. urinary albumin to creatinine ratio (mg/g) [ Time Frame: 6 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Females or males, and aged 20 to 65 years.
  • Type 2 diabetes with microalbuminuria (Urinary albumin /creatinine ratio, ACR, between 30 and 300 mg/g, a first morning spot urine sample will be used to approximate the 24-hour urine albumin excretion) in two consecutive laboratory tests before the study period.
  • At least 2 months statin monotherapy with low to moderate dose (atorvastatin ≤20mg q.d. or rosuvastatin≤10mg q.d. or simvastatin≤40mg q.d. or pravastatin≤40mg q.d.or pitavastatin≤2mg q.d or fluvastatin≤80mg q.d.or lovastatin≤40mg q.d) prior to enrollemnt and plan to continue the same type and dose of statin.
  • TG≥1.7 mmol/L (150mg/dl) and TG<5.65 mmol/L (500mg/dl).
  • HbA1C<8% and blood pressure<140/90mmHg.

Exclusion Criteria:

  • Any contraindication of fenofibrate and statins in Chinese label.
  • Hepatic insufficiency (ALT or AST> 1.5*ULN)
  • Renal insufficiency [Creatinine clearance rate (Ccr)]<60ml/min estimated from MDRD equation)
  • CK > 1.5*ULN
  • Hypothyroidism
  • Use of non-statin lipid-regulating drugs such as niacin and fish oil in previous 1 month
  • Combination use of other fibrates or drug with similar structure, especially ketoprofen
  • Combination use of oral anticoagulants
  • Pregnant or lactating woman
  • Other conditions at investigator's discretion

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Responsible Party: Guang Wang, director of department of endocrinology, Beijing Chao Yang Hospital Identifier: NCT02314533    
Other Study ID Numbers: FENOD003
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents