A clinical trial to study the effects of two drugs, FDC of Atorvastatin and delayed release fenofibric acid and FDC of Atorvastatin and fenofibrate in patients with mixed dyslipidemia.

Evaluation of efficacy and safety of FDC of Atorvastatin and delayed release fenofibric acid versus FDC of Atorvastatin and fenofibrate in patients of mixed dyslipidemia: a randomized, open-label, comparative, multicentric study.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001327

Enrollment

200

Registered

2010-09-07

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: FDC of Atorvastatin and delayed release fenofibric acid capsule: OD for 12 months Control Intervention1: FDC of Atorvastatin and fenofibrate tablets: OD for 12 months.

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 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

Design outcomes

Primary

Measure	Time frame
a)Evaluation of mean percent change in TG b)Evaluation of mean percent change in HDL-C c)Evaluation of mean percent change in LDL-C Timepoint: Baseline (Day 0) and End of treatment (Week 12)	—

Secondary

Measure	Time frame
Evaluation of global impression by investigator and patientTimepoint: Week 12	—

Countries

India

Contacts

Public ContactDr. Surendra Borgharkar

medical.services@sunpharma.com

Outcome results