Rosuvastatin + Fenofibrate Tablets in the Management of Patients with Mixed Dyslipidaemia.

Phase 3

• Conditions: Mixed Dyslipidaemia

• Registration Number: CTRI/2010/091/000467
• Lead Sponsor: Hetero Labs Limited

Brief Summary

1. This is a Comparative, Randomized, Double blind, Parallel, Multicentric study for Efficacy and Safety of Rosuvastatin+ Fenofibrate versus Atorvastatin + Fenofibrate in the Management of Patients with Mixed Dyslipidaemia. 2. The proposed number of subject to be enrolled in to the study is 300 (this number includes the Screening) and data will be submitted 200 completed patients. Study population will comprise of Patients with Mixed Dyslipidaemia. 3. The recommended dose of Rosuvastatin in dose of 10mg + Fenofibrate in dose of 160mg in comparison with Atorvastatin in the dose of 10mg + Fenofibrate in dose of 160mg once daily for 12 weeks. 4. The primary efficacy outcome will be 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 and the secondary efficacy outcome is to evaluate of the safety by assessing the laboratory parameters, treatment emergent adverse events, and overall response of the patient & investigator at the end of the study.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 227

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/dlTG >150mg/dlHDL ?
• 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

?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 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.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	0,4,8 & 12 weeks

Secondary Outcome Measures

Name	Time	Method
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 study	0,4,8 & 12 weeks

Trial Locations

Locations (11)

Apex Hospital; 🇮🇳 Kolhapur, MAHARASHTRA, India

Ashirwad Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Chellam Hospital; 🇮🇳 Salem, TAMIL NADU, India

Dr. B. R. Patel Hospital; 🇮🇳 Vadodara, GUJARAT, India

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Lourd Hospital; 🇮🇳 India

Narayana Hospital; 🇮🇳 Nellore, ANDHRA PRADESH, India

S.V.R.R. Govt. General Hospital; 🇮🇳 Accident, Surgery,, India

Shreenath Hospital; 🇮🇳 Vadodara, GUJARAT, India

SK Sony Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Scroll for more (1 remaining)

Apex Hospital

🇮🇳Kolhapur, MAHARASHTRA, India

Dr. Niranjan M. Rathod

Principal investigator

2312646268

niranjanrathod@hormail.com