TO EVALUATE THE SAFETY AND EFFICACY FDC OF ROSUVASTATIN CALCIUM 5 mg & FENOFIBRATE 145 mg V/S ROSUVASTATIN 5mg IN PATIENTS SUFFERING WITH MIXED DYSLIPEDEMIA?.

Phase 3

Completed

• Conditions: PATIENTS SUFFERING WITH MIXED DYSLIPEDEMIA

• Registration Number: CTRI/2010/091/001437
• Lead Sponsor: CJSC RCI Syntez

Brief Summary

The study will be conducted after obtaining written informed consent from the subjects. The subjects will undergo medical screening during pre-study visit (Visit 1). Screening will include complete clinical evaluation (medical history, physical examination, record of height, weight and vital signs), and laboratory tests {Fasting Serum Lipid Profile, Liver function tests (SGOT, SGPT, Serum Bilirubin), Renal Function Tests (Serum Creatinine, and Serum Uric Acid). Blood sample will be collected for laboratory evaluations during screening. Female volunteers of child bearing capability will be subjected to a urine pregnancy test. The subject would be randomized in two parallel arm and according to the randomization done they would be assigned for the treatment for either of the arm FDC of Rosuvastatin and Fenofibrate ,or monotherapy of Rosuvastatin Calcium

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-20
• Last Update Posted: 2013-05-09

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

Subjects of either sex of age 18 and 70 years.Low-density lipoprotein (LDL)-cholesterol levels > 100 mg/dL, high-density lipoprotein (HDL)-cholesterol levels < 50 mg/dL (for women) and < 40 mg/dl (for men), or triglyceride levels > 150 mg/dL.Willing to give written informed consent.

Exclusion Criteria

Hypersensitivity to either of the formulation components.Severe renal dysfunction.Hepatic dysfunction, including primary biliary cirrhosis and unexplained persistent liver function abnormality.Pre-existing gallbladder disease.xSubjects with a history of known hypersensitivity from any one of the said medication.Pregnant women or lactating woman.Participation in a clinical trial with an investigational agent during the past 30 days.Simultaneous participation in a clinical study.Severe uncontrolled systemic disease.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Change from baseline in low density lipoprotein cholesterol after 12 weeks.	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in total cholesterol, triglycerides, high density lipoprotein cholesterol, and lipoprotein subtypes after 12 weeks.Number of patients who reach target LDL after 12 weeks.	12 weeks

Trial Locations

Locations (6)

Hope Hospital; 🇮🇳 Meerut, UTTAR PRADESH, India

Jeevandeep Hospital; 🇮🇳 Amravati, MAHARASHTRA, India

Kharghar Diabetes And Heart Care Centre; 🇮🇳 Plot, India

Mangalore Heart Centre; 🇮🇳 Bangalore, KARNATAKA, India

Narendra Prakash Health Care Centre,; 🇮🇳 Delhi, DELHI, India

Somdatt Poly Clinic; 🇮🇳 Delhi, DELHI, India

Hope Hospital

🇮🇳Meerut, UTTAR PRADESH, India

DR. TANURAJ SIROHI

Principal investigator

09837052678

trsirohi@yahoo.com