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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02015988
Other study ID # A14-284
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received December 14, 2013
Last updated August 3, 2016
Start date January 2014
Est. completion date May 2017

Study information

Verified date August 2016
Source Dnipropetrovsk State Medical Academy
Contact n/a
Is FDA regulated No
Health authority Ukraine: Ministry of Health
Study type Interventional

Clinical Trial Summary

To test the hypothesis that early (within 5-21 days after index event) administration of combined lipid-lowering therapy in extremely high risk population of patients with type 2 diabetes mellitus (T2DM) and hypertriglyceridemia (HTG) who experienced acute coronary syndrome (ACS) will be effective and well tolerated in achievement of contemporary strict requirements for triglyceride (TG) levels as an independent risk factor in the case of HTG with diabetes.


Description:

The primary objective of this parallel group study is to demonstrate that the combined therapy of simvastatin and fenofibrate is superior compared to monotherapy with simvastatin based on the comparisons of change of TG levels after 12 weeks of treatment compared to baseline.

Secondary objectives are to compare both treatment alternatives the combination therapy of simvastatin and fenofibrate to simvastatin monotherapy with respect to achievement the European Society of Cardiology 2011 (ESC 2011) non-HDL-C target (less than 2,6 mmol/l), change of apolipoprotein B/apolipoprotein A1 (apoB/apoA1) ratio, High-Density Lipoprotein-Cholesterol (HDL-C), Low-Density Lipoprotein-Cholesterol (LDL-C) and Uric Acid (UA) after 12 weeks and 52 weeks (1 year) of treatment compared to baseline.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date May 2017
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Type 2 Diabetes Mellitus

- Fasting triglycerides = 1,7 mmol/l

- Acute coronary syndrome at least before 5 and maximum 21 days before the inclusion

- If previously treated with statin therapy, the dose should be equivalent to 40 mg of simvastatin at inclusion

- In case of previous statin therapy, last LDL-C measurement before event should be = 2,6 mmol/l

- Written informed consent obtained

Exclusion Criteria:

- Heart failure IV class (NYHA)

- Acute decompensated heart failure

- Life expectancy no more than 1 year

- Chronic kidney disease (CKD) with Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2

- Severe chronic liver diseases with Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 3 Upper Limit of Normal (ULN)

- Known gallbladder disease, including cholecystolithiasis

- Creatinphosphokinase (CPK) > 5 ULN at baseline

- Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia

- Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen,

- Known allergy to peanut or arachis oil or soya lecithin or related products

- Hypersensitivity to simvastatin or fenofibrate or to any of the excipients of the investigational drugs

- Concomitant administration of potent cytochrome P450 isoenzyme 3A4 inhibitors (e.g. itraconazole, ketoconazole, fluconazole, posaconazole, Human Immunodeficiency Virus (HIV) protease inhibitors (e.g. nelfinavir), erythromycin, clarithromycin, telithromycin and nefazodone)

- Pregnancy and lactation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Fenofibrate

Simvastatin


Locations

Country Name City State
Ukraine State Institution "Dnipropetrovsk Medical Academy of Health Ministry of Ukraine" Dnipropetrovsk

Sponsors (1)

Lead Sponsor Collaborator
Koval' O., MD

Country where clinical trial is conducted

Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of adverse events (AE) caused discontinuations of investigational products Up to 52 week Yes
Primary Percentage change from baseline in triglycerides (TG) at week 12 Baseline, Week 12 No
Secondary Percentage of patients who achieved non-High-Density Lipoprotein-Cholesterol (non-HDL-C) level less than 2,6 mmol/l at week 12 Week 12 No
Secondary Percentage changes from baseline in apoB/apoA1 ratio at week 12 Baseline, Week 12 No
Secondary Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 12 Baseline, Week 12 No
Secondary Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 12 Baseline, Week 12 No
Secondary Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 12 Baseline, Week 12 No
Secondary Percentage changes from baseline in uric acid at week 12 Baseline, Week 12 No
Secondary Percentage of patients who achieved non-High-Density Lipoprotein-Cholesterol (non-HDL-C) level less than 2,6 mmol/l at week 52 Week 52 No
Secondary Percentage changes from baseline in apoB/apoA1 ratio at week 52 Baseline, Week 52 No
Secondary Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 52 Baseline, Week 52 No
Secondary Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 52 Baseline, Week 52 No
Secondary Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 52 Baseline, Week 52 No
Secondary Percentage changes from baseline in uric acid at week 52 Baseline, Week 52 No
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