A randomised, double-blind study comparing the efficacy and safety of 145mg NanoCrystal® fenofibrate, 10mg ezetimibe and their combination in patients with type IIb dyslipidemia and features of the metabolic syndrome. - see protocol page 1
- Conditions
- Patients with type IIb dyslipidemia and features of the metabolic syndrome.
- Registration Number
- EUCTR2004-002408-13-DE
- Lead Sponsor
- FOURNIER Laboratories Ireland Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 186
Patients will be selected for V1 based on the biological values (not older than 6 months) of LDL-C, HDL-C and TG in their medical files.
A patient will be eligible for study participation if he/she meets the following criteria at randomisation (V2):
1. Both genders, from 18 to 70 years old,
2. Presenting with type IIb dyslipidemia, as evidenced by:
• LDL-C >or= 160 mg/dL (>or= 4.15 mmol/L)
• TG >or= 150 mg/dL (>or= 1.7 mmol/L), and 3. In addition, they should have at least 2 of 4 following criteria, thus qualifying for the ATPIII/NCEP criteria for metabolic syndrome :
• Waist circumference: men >102 cm, women >88cm
• HDL cholesterol: men < 40 mg/dL (<1 mmol/L) and women <50 mg/dL (<1.3 mmol/L)
• Blood pressure = 130 / = 85 mm Hg
• Fasting glucose = 110 mg/dL (= 6.1 mmol/L)
4. With negative pregnancy test and a reliable method of contraception in female of
child bearing potential
5. Having signed a written informed consent at inclusion (V1)
6. Patient must be willing to observe the Step I Diet recommended by the NCEP throughout the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
A patient will be excluded from the study if he/she meets any of the following criteria at V2:
1. Known hypersensitivity to fibrates or ezetimibe or known photoallergic or phototoxic reactions under treatment with fibrates or ketoprofen.
2. Women who are not surgically sterilized or not using adequate contraceptive precautions or not postmenopausal
3. Pregnant or lactating women
4. Having received an investigational drug or vaccine in the last 30 days before date of inclusion, or still participating in such a trial at V1
Associated diseases or conditions:
5. Type 1 or type 2 diabetes (fasting plasma glucose = 7 mmol/L)
6. Current chronic pancreatitis or identified risk or known history of acute pancreatitis
7. Known cholelithiasis in absence of cholecystectomy
8. Known gastric or peptic ulcer or intestinal disease within the previous 3 months of randomisation capable of modifying the intestinal absorption of the drugs
9. Significant hepatic disease: AST and/or ALT > 2 times the upper normal limit (UNL)
10. Acute alcohol intoxication, known alcoholism
11. Past medical history of myositis, myopathy or rhabdomyolysis
12. Musculoskeletal disease with increased Creatine phosphokinase (CK) > 3 times UNL
13. Renal failure or renal dysfunction defined by serum creatinine levels > 135 µmol/L in males and >110 µmol/L in females
14. Known abnormal thyroid hormone levels, or high thyroid stimulating hormone (TSH) level
15. Uncontrolled hypertension (SBP > 180 mm Hg and/or DBP > 110 mm Hg)
16. History of coronary heart disease (CHD), CHD-equivalent disease, or CHD risk >20% as defined by NCEP ATP III criteria
17. Any other severe pathology such as cancer, mental illness, chronic respiratory insufficiency, etc…, which in the opinion of the investigator might pose a risk to the patient or confound the results of the study
18. Treated with anti-diabetic drug(s), Cyclosporin A, anticoagulants, protease inhibitors
19. Treated within the last 4 to 6 weeks before randomisation with lipid lowering drug
20. Treated within the last 4 to 6 weeks before randomisation and/or surgery with weight lowering drugs
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate, in patients with type IIb dyslipidemia and features of the metabolic syndrome, the clinical advantage of 145mg NanoCrystal® fenofibrate over 10mg ezetimibe on plasma triglycerides (TG) and HDL-cholesterol (HDL-C) levels.;Secondary Objective: To compare the efficacy of 145mg NanoCrystal® fenofibrate, 10mg ezetimibe and combined therapy (145mg NanoCrystal® fenofibrate + 10mg ezetimibe) from baseline to 12 weeks treatment on Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Non HDL-Cholesterol, LDL size, Remnant Like Particles Cholesterol (RLP-C), Apo AI, Apo AII, Apo B, hs CRP, Fasting plasma Glucose and Insulin, HOMA-IR.<br><br>To assess the safety of 145mg NanoCrystal® fenofibrate, 10mg ezetimibe and combined therapy after 12 weeks of treatment.;Primary end point(s): Percent change in TG and HDL-C from baseline to 12 weeks treatment between 145mg NanoCrystal® fenofibrate and 10mg ezetimibe.
- Secondary Outcome Measures
Name Time Method