A clinical trial to study the effects of two drugs, Fixed dose combination of tablets of Rosuvastatin 5 mg and Fenofibrate 160mg with Rosuvastatin 5mg alone in patients with dyslipidemia

A multicentric, open label, randomized, comparative, parallel group, active controlled Phase III clinical trial of the safety and efficacy of Fixed dose combination of tablets of Rosuvastatin 5 mg and Fenofibrate 160mg with Rosuvastatin 5mg alone in patients with dyslipidemia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000147

Enrollment

200

Registered

2010-03-25

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 and Fenofibrate: 5mg and 160 mg, once daily Control Intervention1: Rosuvastatin: 5mg , once daily

Eligibility

Inclusion criteria

Inclusion criteria: Male and female outpatients between 18-75 tears of age. Patients having i. LDL cholesterol>130mg/dl ,ii.Serum triglycerides > or equal to 150mg/dl and < or equal to 500mg/dl. Able to stop current statin therapy without risk to the patient Patients who are able to adequately maintain diary. Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved ICF

Exclusion criteria

Exclusion criteria: No willing to sign ICF, Hypersensitivity to statins, Serum triglyceride levels > 500mg/dl.Patients with hepatic disease, poorly controlled diabetes mellitus, patients familiar with muscular pain, myopathy.Stroke less than six months prior to informed consent. pregnancy and lactation, history of pancreatitis

Design outcomes

Primary

Measure	Time frame
change from baseline values of LDL-C, serum triglycerides, HDL-CTimepoint: 12 weeks	—

Secondary

Measure	Time frame
Achievement of target levels of total cholesterolnd LDL cholesterol, patient complianceTimepoint:	—

Countries

India

Contacts

Public ContactDr. Nitin M Rathod

nitinmr@yahoo.in

Outcome results