A clinical trial to study the effects of two antihyperlipidemics in patients with mixed dyslipidemia.

Evaluation of efficacy and safety of two antihyperlipidemics as an adjunctive therapy in patients of mixed dyslipidemia, who are already on treatment with statins: an open-label, comparative, multicentric study.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000556

Enrollment

200

Registered

2010-06-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: fenofibric acid delayed release capsules 135mg: OD for 12 Weeks Control Intervention1: Fenofibrate 160mg tablets: OD for 12 Weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male or Female patients aged between 18 to 70 years. 2.Patients with Fasting TG &&#8805; 150mg/dl, HDL-C < 40mg/dl for men and < 50mg/dl for women and LDL-C & &#8805;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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
1.Evaluation of mean percent change in TGTimepoint: Day 0 and week 12.	—

Secondary

Measure	Time frame
1.Evaluation of mean percent change in HDL-C 2.Evaluation of mean percent change in LDL-C- 3.Evaluation of global impression by patients and investigatorTimepoint: 1.Day 0 and week 12 2.Day 0 and week 12 3.Week 12	—

Countries

India

Contacts

Public ContactDr. Surendra Borgharkar

medical.services@sunpharma.com02266969696

Outcome results