A randomized, active-controlled, open-label, multicenter cross-over study with two 6-week treatment periods to investigate the effect of the combination of Lescol XL (fluvastatin) 80 mg and fenofibrate 200 mg on HDL-C in comparison to the combination of simvastatin 20 mg and ezetimibe 10 mg in patients with metabolic syndrome

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-002007-13-DE
• Date of registration: 26/04/2006
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma GmbH
• Public title: A randomized, active-controlled, open-label, multicenter cross-over study with two 6-week treatment periods to investigate the effect of the combination of Lescol XL (fluvastatin) 80 mg and fenofibrate 200 mg on HDL-C in comparison to the combination of simvastatin 20 mg and ezetimibe 10 mg in patients with metabolic syndrome
• Scientific title: A randomized, active-controlled, open-label, multicenter cross-over study with two 6-week treatment periods to investigate the effect of the combination of Lescol XL (fluvastatin) 80 mg and fenofibrate 200 mg on HDL-C in comparison to the combination of simvastatin 20 mg and ezetimibe 10 mg in patients with metabolic syndrome
• Date of first enrolment: 29/06/2006
• Target sample size: 70
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002007-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
1. Written informed consent to participate in the study prior to any study procedures.
2. Male or female subjects, age between 18-75 years inclusive.
3. All women of child bearing potential must have a negative pregnancy test
4. Metabolic Syndrome according to the IDF definition:
a) Low plasma HDL-C (Men < 40 mg/dl; Women < 50 mg/dl).
b) Elevated waist circumference (men = 94 cm, women = 80cm)
c) And one ore more of the following criteria:
i) Triglycerides = 150 mg/dl
ii) Raised blood pressure (DBP = 85 mmHg and/or SBP = 130mmHg) or treated hypertension.
iii) FPG = 100mg/dl.
iv) Previously diagnosed type 2 diabetes.

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

Exclusion criteria:
1. Patients with homozygous familial hypercholesterolemia, and Fredrickson Types I, IV and V dyslipoproteinemia.
2. Dyslipidemia secondary to other causes such as nephrotic syndrome, autoimmune disease etc.
3. Type 1 diabetes or secondary type 2 diabetes such as cushing syndrome
4. Lipid-lowering agents: A 6-week wash out period from HMG-CoA reductase inhibitors, fibrate derivatives, niacin and anti-obesity drugs is required. Patients treated with probucol should have discontinued it for at least one year.
5. Triglyceride levels > 1000 mg/dL (11.28 mmol/L) at week -1.
6. FPG > 270 mg/dL (15 mmol/L) at week -1.
7. HbA1c > 9.5% at week -1.
8. ALT/SGPT and/or AST/SGOT > 2 x ULN at Visit 2/Week -1.
9. Impaired renal function with a serum creatinine > 2 x ULN at Visit 2/Week -1.
10. Unexplained serum CPK levels >2 x ULN at Visit 2/Week -1.
11. History of dialysis or of nephrotic syndrome.
12. History or evidence of muscular or neuromuscular disease.
13. Malignant or poorly controlled hypertension (SBP>160mmHg, DBP >100mmHg).
14. History of severe cardiovascular disease (myocardial infarction, bypass surgery, coronary angioplasty, cerebral stroke, unstable angina pectoris).
15. History of heart failure (e.g., New York Heart Association Class II and above).
16. Any surgical or medical conditions which, at the discretion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period.

Further exclusion criteria are defined in the study protocol


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Dyslipidaemia
MedDRA version: 5.1 Level: LLT Classification code 10058108

Intervention(s)

Trade Name: Locol 80 mg Retardtabletten
Product Name: Locol 80 mg Retardtabletten
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Fluvastatin
CAS Number: 93957-55-2
Current Sponsor code: XUO320
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-

Trade Name: Inegy 10mg/20mg Tabletten
Product Name: Inegy 10mg/20mg Tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: Ezetimib
CAS Number: 163222-33-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
INN or Proposed INN: Simvastatin
CAS Number: 79902-63-9
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 20-

Trade Name: Fenofibrat Sandoz 200mg Hartkapseln
Product Name: Fenofibrat Sandoz 200 mg Hartkapseln
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Fenofibrate
CAS Number: 49562-28-9
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)

Main Objective: To confirm that the combination of fluvastatin 80 mg extended release (ER) and fenofibrate 200 mg has superior efficacy in increasing HDL-C compared with the combination of simvastatin 20 mg and ezetimibe 10 mg after a treatment period of 6 weeks each in patients with type 2 diabetes/metabolic syndrome

Secondary Objective: To compare the effects of the combination of fluvastatin 80 mg ER and fenofibrate 200 mg to the combination of simvastatin 20 mg and ezetimibe 10 mg on the following parameters
1. Number of patients reaching target levels of LDL-C <100mg/dl
2. Number of patients reaching target levels of non-HDL-C <130mg/dl
3. LDL-C/HDL-C
4. Apolipoprotein A-I
5. Triglycerides
6. Total cholesterol
7. LDL subfractions in a subgroup of patients
8. Endothelial function in a subgroup of patients
9. Liver enzymes and CPK levels

Primary end point(s): The primary parameter of the study will be HDL-C measured at the end of each study period.

Secondary ID(s)

CXUO320BDE35