A clinical trial to study the effects of two antihyperlipidemics in patients with mixed dyslipidemia.
- Registration Number
- CTRI/2010/091/000556
- Lead Sponsor
- Fax: 631-656-1006
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
1.Male or Female patients aged between 18 to 70 years.
2.Patients with Fasting TG &≥ 150mg/dl, HDL-C < 40mg/dl for men and < 50mg/dl for women and LDL-C & ≥130mg/dl.
3.Patients who are already on statin for at least 4 weeks and not adequately controlled.
4.Patients willing to give their informed consent.
1.Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
2.Patients with cardiovascular disease, type 1 diabetes mellitus.
3.Patients with significantly abnormal laboratory analysis of thyroid function.
4.Patients with severe renal impairment, including those receiving dialysis.
5.Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.
6.Patients with preexisting gallbladder disease.
7.Patients with hypersensitivity to fenofibric acid or statin.
8.Patients taking oral coumarin anticoagulant.
9.Patient on treatment cyclosporine, niacin (nicotinic acid), erythromycin, azole antifungals.
10.Patients taking antacid, Colestipol.
11.Patients on treatment of endogenous steroid hormones such as ketoconazole, spironolactone, and cimetidine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Evaluation of mean percent change in TGTimepoint: Day 0 and week 12.
- Secondary Outcome Measures
Name Time Method 1.Evaluation of mean percent change in HDL-C<br>2.Evaluation of mean percent change in LDL-C- 3.Evaluation of global impression by patients and investigatorTimepoint: 1.Day 0 and week 12<br>2.Day 0 and week 12<br>3.Week 12<br>