A clinical trial to study effectiveness and safety of two medications in patients suffering from dyslipidemia (abnormal lipid levels in blood)

Phase 3

Completed

• Conditions: Hyperlipidemia, unspecified,

• Registration Number: CTRI/2011/04/001689
• Lead Sponsor: Cadila Healthcare Ltd

Brief Summary

Open label, randomized, phase III, multicentricstudy.

Comparison of efficacy and safety ofFenofibric acid delayed release capsules verses Fenofibrate tablets in theIndian dyslipidemic patients.

Primary outcome of the study was themean percentage change from baseline in the serum Triglycerides (TGs) at theend of the treatment phase.

Fenofibricacid delayed release capsules have a comparable therapeutic efficacy asFenofibrate tablets in Indian patients suffering from dyslipidemia.

On the tolerability front Fenofibricacid delayed release capsules were as well tolerated as Fenofibrate tablets.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-03
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1.Patients with hypertriglyceridemia at the time of enrollment 2.Informed consent.

Exclusion Criteria

• 1.Pregnancy, lactation and women of childbearing potential not using appropriate contraceptive measures.
• 2.Patients already receiving drugs belonging to the fibric acid derivatives.
• 3.Patients with hepatic or renal dysfunction.
• 4.Patients with history of myopathy or evidence of active muscle disease.
• 5.Patients with any other serious concurrent illness or malignancy.
• 6.Patients with continuing history of alcohol and / or drug abuse.
• 7.Patients with persistent gall bladder diseases.
• 8.Patients with known hypersensitivity to fenofibric acid.
• 9.Participation in another clinical trial in the past 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The mean percentage change from baseline in the serum Triglycerides (TGs) at the end of the treatment phase	At baseline (Week 0) and at the end of study (Week 12)

Secondary Outcome Measures

Name	Time	Method
1) The mean percentage change from baseline in other lipid profile at the end of the treatment phase	2) Evaluation of global efficacy by the investigator

Trial Locations

Locations (5)

Diabetes, Obesity and Thyroid Centre; 🇮🇳 Gwalior, MADHYA PRADESH, India

K2 Clinic; 🇮🇳 Jaipur, RAJASTHAN, India

Medilink Hospital & Research Centre; 🇮🇳 Ahmadabad, GUJARAT, India

S.P. Medical College and A.G. Hospitals, Bikaner; 🇮🇳 Bikaner, RAJASTHAN, India

Shashwat Hospital & Research Centre; 🇮🇳 Ahmadabad, GUJARAT, India

Diabetes, Obesity and Thyroid Centre

🇮🇳Gwalior, MADHYA PRADESH, India

Dr Navneet Agrawal

Principal investigator

navneetdotc@gmail.com