A clinical trial to study the effects of two drugs, Fixed dose combination of tablets of Rosuvastatin 5 mg and Fenofibrate 160mg with Rosuvastatin 5mg alone in patients with dyslipidemia

Phase 3

• Conditions: Dyslipidemia

• Registration Number: CTRI/2010/091/000147
• Lead Sponsor: M/s. Ravenbhel Healthcare Pvt. Ltd.

Brief Summary

This study is a multicentric, open label, randomized, comparative, parallel group, active controlled Phase III clinical trial of the efficacy and safety of FDC of tablets of Rosuvastatin 5 mg and Telmisartan 160 mg with Rosuvastatin 5mg alone in patients with dyslipidemia in 200 patients will be conducted in 4 centres in India

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

• Male and female outpatients between 18-75 tears of age.Patients having i.
• LDL cholesterol>130mg/dl ,ii.Serum triglycerides > or equal to 150mg/dl and < or equal to 500mg/dl.Able to stop current statin therapy without risk to the patientPatients who are able to adequately maintain diary.Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved ICF.

Exclusion Criteria

• No willing to sign ICF, Hypersensitivity to statins, Serum triglyceride levels > 500mg/dl.Patients with hepatic disease, poorly controlled diabetes mellitus, patients familiar with muscular pain, myopathy.Stroke less than six months prior to informed consent.
• pregnancy and lactation, history of pancreatitis.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
change from baseline values of LDL-C, serum triglycerides, HDL-C	12 weeks

Secondary Outcome Measures

Name	Time	Method
Achievement of target levels of total cholesterolnd LDL cholesterol, patient compliance

Trial Locations

Locations (4)

Clinic, Bhavnagar, Rajivoza59@hotmail.com; 🇮🇳 Bhavnagar, GUJARAT, India

Dr. R.N.Cooper Hospital, Vileparle west,Mumbai,nitinmr@yahoo.in; 🇮🇳 Mumbai, MAHARASHTRA, India

K E M Hospital, Mumbai, pkirtic@yaahoo.in; 🇮🇳 Mumbai, MAHARASHTRA, India

Smt. N H L Muni. medical college Ahmedabad, Rajpurvi@yahoo.com; 🇮🇳 Ahmadabad, GUJARAT, India

Clinic, Bhavnagar, Rajivoza59@hotmail.com

🇮🇳Bhavnagar, GUJARAT, India

Dr. Rajiv R Oza

Principal investigator

Rajivoza59@hotmail.com