None listed
Conditions
Interventions
Intervention1: A FDC of Rosuvastatin 10mg + Fenofibrate 160mg: Rosuvastatin 10mg + Fenofibrate 160mg,once daily, Duration 12 weeks
Control Intervention1: A FDC of Atorvastatin 10mg + Fenofibrate 160mg
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subjects of both sexes aged between 18-65 years will be included in the study. Patients lipid results after 10-12 hour fasting interval including: LDL-C > 130mg/dl TG >150mg/dl HDL ? C < 40mg / dl for men and < 50 mg / dl for women ?Mixed dyslipidaemia Naive subjects / with or without dietary counselling (OR) ?Subjects receiving treatment with starting dose of other lipid lowering therapies, but who have failed to achieve the LDL-C goal levels as per NCEP ATP III guidelines
Exclusion criteria
Exclusion criteria: ?Patients unwilling or unable to give informed consent ?Patients with secondary hypercholesterolemia, known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoprotenaemia) ?Patients with uncontrolled diabetes (i.e. fasting blood sugar > 140 mg/dl), nephrotic syndrome, myeloma, obstructive liver disease, hypothyroidism, alcoholism ?Patients with clinically significant gastrointestinal, respiratory, hepatic, renal or haematological disorder or any other severe concurrent illness, major surgery or acute infection, gram negative sepsis, extensive burns or cancer within past 5 years ?Patients with unstable angina, severe heart failure, cardiac arrhythmias, myocardial infarction, coronary artery bypass surgery, coronary angioplasty within three months prior to inclusion in the study. ?Patients with suspected bilateral renal artery stenosis, single kidney. ?Patients with active liver disease or hepatic dysfunction as defined by elevations of SGOT or SGPT > 1.5 times the ULN, alkaline Phosphatase or total serum bilirubin > 1.2 times ULN, serum creatinine >1.2 mg/dl or creatinine phosphokinase &#61619;1.5 times ULN ?Patients requiring treatment with potent CYP3A4 inhibitors like cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin ?Patients who had experienced unexplained muscle pain, tenderness or weakness with any other medication of statin group previously ?Pregnant women, women who are breast feeding, and women of childbearing potential not using medically accepted methods of contraception ?Participation in another investigational drug trial within the previous 4 weeks ?Subjects randomised to treatment who subsequently withdraw cannot re-enter this trial ?Subjects with serious or unstable medical or psychological condition that in the opinion of the investigator would compromise the subject?s safety or successful participation in the trial. ?NACP target reach
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects who reach LDL-C goals as per NCEP ATP III guidelines, Percentage of subjects who reach the target goal of HDL-C > 40mg/dl for men and > 50mg/dl for women, Percentage of patients who reach the target goal of TG <150mg/dl after 12 weeks of study.Timepoint: 0,4,8 & 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The Secondary outcome is to evaluate safety by assessing the laboratory parameters, treatment emergent adverse events, and overall response of the patient & investigator at the end of the studyTimepoint: 0,4,8 & 12 weeks | — |
Countries
India
Contacts
Public ContactB Mohan Reddy
NIMS
Outcome results
None listed