A clinical trial to study the effects of Daily Vs Alternate day therapy with Atorvastatin and Fenofibrate combination in the treatment of Mixed Dyslipidemia.

Phase 4

Completed

• Conditions: Mixed Dyslipidemia

• Registration Number: CTRI/2010/091/001328
• Lead Sponsor: NIL Investigator Initiated Trial

Brief Summary

This is a Randomized, open labeled, parallel group, single centre study to evaluate the efficacy and safety of Alternate day therapy with Atorvastatin and Fenofibrate combination in comparison with Daily therapy in the treatment of Mixed Dyslipidemia. 110 patients diagnosed with Mixed Dyslipidemia requiring pharmacological treatment as per Updated NCEP-ATP III guidelines will be enrolled in the study. (55 study participants in each group). Only the patients satisfying the eligibility criteria and willing to participate in the study by voluntarily signing the informed consent form will be included in the study. The study drug is Fixed Dose Combination of Atorvastatin 10mg and Fenofibrate 160mg.The participants in the interventional group will receive the study drug on Alternate days for 12weeks. The study participants in the control group will receive the study drug daily for 12weeks. The primary endpoint is the percent change in TGL and non-HDL levels from baseline to 12weeks of therapy. The secondary endpoints are Percent change in Total Cholesterol, HDL, VLDL, LDL Cholesterol, TC/HDL ratio and TGL/HDL ratio from baseline to 12weeks of therapy, Pharmacoeconomic evaluation in both groups. The safety endpoints are Incidence of Adverse events in both groups and Percent change in SGOT, SGPT from baseline to 12weeks of therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-20
• Last Update Posted: 2013-10-03

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 110

Inclusion Criteria

1. Adult Male and Female patients of age >18years and <= 65years who are diagnosed as Mixed Dyslipidemia and meet the criteria for pharmacological treatment as per updated NCEP-ATP III guidelines 2) Fasting LDL levels >= 130mg/dL, Fasting TGL levels >= 200mg/dL, Fasting Total Cholesterol levels >= 200mg/dL 3) Patients who failed to achieve lipid target goals as per updated NCEP-ATP III guidelines with Therapeutic life style changes or with other modalities of treatment 4) Eligible patients who are willing to participate in the study by voluntarily signing the Informed Consent Form.

Exclusion Criteria

• 1. Patients who are already on treatment with statins or fibrates.
• 2. Patients allergic/hypersensitive to either Atorvastatin or Fenofibrate.
• 3. Pregnant and Lactating women.
• 4. Women of child bearing age not using acceptable methods of contraception.
• 5. Patients with active liver disease having elevated liver enzymes.
• 6. Patients with Uncontrolled Diabetes Mellitus with FBS>200mg/dL even after therapy with OHA/Insulin.
• 8. Post-MI, Post-CABG, Post-PTCA, Post-Stroke patients within six months of occurrence of the event.
• 9. CCF patients receiving Digoxin.
• 10. Patients unwilling to give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent change in TGL and non-HDL levels from baseline to 12weeks of therapy.	0, 6weeks, 12weeks

Secondary Outcome Measures

Name	Time	Method
1) Percent change in Total Cholesterol, HDL, VLDL, LDL Cholesterol, TC/HDL ratio and TGL/HDL ratio from baseline to 12weeks of therapy. 2)Incidence of Adverse events in both groups and Percent change in SGOT, SGPT from baseline to 12weeks of therapy. 3)Pharmacoeconomic evaluation in both groups.	0, 6weeks, 12weeks

Trial Locations

Locations (1)

Dept. of Internal Medicine & Dept. of Cardiology, Sri Ramachandra Medical College Hospital, Porur, Chennai-600116; 🇮🇳 Chennai, TAMIL NADU, India

Dept. of Internal Medicine & Dept. of Cardiology, Sri Ramachandra Medical College Hospital, Porur, Chennai-600116

🇮🇳Chennai, TAMIL NADU, India

Dr. N. Hari Venkatesh

Principal investigator

044-24768403

dr_harivenkatesh@yahoo.co.in