TO EVALUATE THE SAFETY AND EFFICACY FDC OF ROSUVASTATIN CALCIUM 5 mg & FENOFIBRATE 145 mg V/S ROSUVASTATIN 5mg IN PATIENTS SUFFERING WITH MIXED DYSLIPEDEMIA?.

"A CONTROL LABELED, RANDOMIZED, COMPARATIVE, PARALLEL GROUP, MULTICENTRIC PHASE III STUDY TO EVALUATE THE SAFETY AND EFFICACY FDC OF ROSUVASTATIN CALCIUM 5 mg & FENOFIBRATE 145 mg V/S ROSUVASTATIN 5mg IN PATIENTS SUFFERING WITH MIXED DYSLIPEDEMIA".

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001437

Enrollment

200

Registered

2010-11-12

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 ROSUVASTATIN CALCIUM 5 mg &amp

FENOFIBRATE 145 mg: ROSUVASTATIN CALCIUM 5 mg &amp

FENOFIBRATE 145 mg for 12 weeks Control Intervention1: ROSUVASTATIN: 5mg for 12 weeks

Eligibility

Inclusion criteria

Inclusion criteria: Subjects of either sex of age &#61619;18 and &#61603;70 years. Low-density lipoprotein (LDL)-cholesterol levels > 100 mg/dL, high-density lipoprotein (HDL)-cholesterol levels < 50 mg/dL (for women) and < 40 mg/dl (for men), or triglyceride levels > 150 mg/dL. Willing to give written informed consent.

Exclusion criteria

Exclusion criteria: Hypersensitivity to either of the formulation components. Severe renal dysfunction. Hepatic dysfunction, including primary biliary cirrhosis and unexplained persistent liver function abnormality. Pre-existing gallbladder disease. x Subjects with a history of known hypersensitivity from any one of the said medication. Pregnant women or lactating woman. Participation in a clinical trial with an investigational agent during the past 30 days. Simultaneous participation in a clinical study. Severe uncontrolled systemic disease.

Design outcomes

Primary

Measure	Time frame
Change from baseline in low density lipoprotein cholesterol after 12 weeks.Timepoint: 12 weeks	—

Secondary

Measure	Time frame
Change from baseline in total cholesterol, triglycerides, high density lipoprotein cholesterol, and lipoprotein subtypes after 12 weeks. Number of patients who reach target LDL after 12 weeks. Timepoint: 12 weeks	—

Countries

India

Contacts

Public ContactDr Amit Bhatt

Nexus Clinical Research (India) Ltd

dramit.bhatt@gmail.com+91-22-27714204

Outcome results