A clinical trial to study the effects of Rosuvastatin and Fenofibrate in patients with primary hypercholesterolemia not adequately controlled with statin or fibrate monotherapy.
- Registration Number
- CTRI/2009/091/001061
- Lead Sponsor
- Sun Pharmaceutical Industries Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
1.Male or female patients aged between 18 - 70 years.
2.Patients with fasting plasma LDL concentrations 145 mg/dl and < 250 mg/dl (6.47 mmol/L) and fasting triglyceride levels 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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Average change from baseline to end of trial in LDL- cholesterolTimepoint: Day o, Week 4, week 8, week 12
- Secondary Outcome Measures
Name Time Method 1. Average change from baseline to end of trial in<br><br>?Total- cholesterol <br>?Triglycerides <br>?HDL-cholesterol <br>2. Global evaluation by patients and investigator<br>Timepoint: 1. Time Points: Day o, Week 4, week 8, week 12 <br>2. Time Points: week 12<br>