A clinical trial to study the effects of Rosuvastatin and Fenofibrate in patients with primary hypercholesterolemia not adequately controlled with statin or fibrate monotherapy.

Evaluation of efficacy and safety of fixed dose combination of rosuvastatin and fenofibrate in the treatment of primary hypercholesterolemia not adequately controlled with statin or fibrate monotherapy: an open-label, non-comparative, multi-centre trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/001061

Enrollment

100

Registered

2010-01-19

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: Rosuvastatin 10mg and Fenofibrate 160mg tablets: once daily for 12 weeks. Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male or female patients aged between 18 - 70 years. 2.Patients with fasting plasma LDL concentrations &#61619;145 mg/dl and < 250 mg/dl (6.47 mmol/L) and fasting triglyceride levels &#61603;400 mg/dl (4.52 mmol/L). 3.Patients who are not appropriately controlled with statin or fibrate therapy. 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 known hypersensitivity rosuvastatin /fibrates. 3.Patients with active liver disease or with unexplained persistent elevations of serum transaminase. 4.Patients with renal impairment advanced, hypothyroidism, hepatic dysfunction, preexisting gall bladder disease. 5.Patients with elevated CK and myopathy. 6.Patients with unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. 7.Patients on gemfibrozil treatment.

Design outcomes

Primary

Measure	Time frame
Average change from baseline to end of trial in LDL- cholesterolTimepoint: Day o, Week 4, week 8, week 12	—

Secondary

Measure	Time frame
1. Average change from baseline to end of trial in ?Total- cholesterol ?Triglycerides ?HDL-cholesterol 2. Global evaluation by patients and investigator Timepoint: 1. Time Points: Day o, Week 4, week 8, week 12 2. Time Points: week 12	—

Countries

India

Contacts

Public ContactDr. Surendra Borgharkar

medical.services@sunpharma.com02266969696

Outcome results