A study to evalutate the safety and efficacy of fixed dose combination of rosuvastatin calcium (5mg/10mg/20mg) with olmesartan medoxomil (20 mg) versus monotherapy of rosuvastatin calcium (10 mg) and olmesartan medoxomil (20 mg)
- Conditions
- Health Condition 1: null- Hypertension in dyslipidemic patients
- Registration Number
- CTRI/2011/12/002303
- Lead Sponsor
- Biocon Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
•Male and female patients with primary hypertension and hyper LDL cholesterolemia, aged 18-80 years (both years inclusive)
•Patients with a history of continuous elevated SBP >=140 mm of Hg / DBP >=90 mm of Hg
•Patients with LDL-C >=130 mg/dl and <=189mg/dl on fasting condition
•Hypertensive patients who are not taking treatment or taking irregular treatment and hypertensive patients who are not responding to the treatment; but not on olmesartan
•Patients who are willing to comply with all study requirements
•Females of childbearing potential should have a negative pregnancy test at the pre study visit and agree to use contraception during the study
•Patient willing to give informed consent
•Patients who are unlikely to comply with protocol requirements (e.g., non-cooperative behavior, inability to attend the requirement of the protocol)
•Patients who are currently participating or had participated in other interventional study for last 3 months prior to their enrolment
•Women who are pregnant, breast feeding or have the intention of becoming pregnant during their participation in the study.
•Women of childbearing potential who are not using effective and medically acceptable methods of contraception
•Patients who are meeting any of the contraindications of the study medication according to the approved SPC
•Secondary type of hypertensive patients
•Known CVD, triglycerides 500 mg/dlmg/dl, renal disease (serum creatinine levels 1.6 mg/dl), hypothyroidism, liver disease (SGOT and/or SGPT levels 3-fold upper limit of normal in more than 2 consecutive measurements), alcohol consumption 3 drinks/day for men and 2 drinks/day for women, and current or previous gout.
•Patients with co-morbid diseases will be included in the study if they are adequately controlled (no change in their treatment will be made during the study period).
•Patients who are positive for HIV test
•Patients with hypertension will be included in the study if they are on stable medication for at least 3 months and their blood pressure is adequately controlled (no change in their treatment will be made during the study period).
•Concurrent use of large quantities of grapefruit juice
•Known hypersensitivity or intolerance to HMG Co-A reductase inhibitors and/or angiotensin receptor blockers, hereditary fructose intolerance
•Patients currently taking lipid-lowering drugs (other than statins at a conventional dose) or having stopped them less than 30 days before study entry will be excluded
•Patients currently undertaking drugs like Cyclosporine, Niacin, Fenofibrate, Gemfibrozil, Lopinavir (or protease inhibitors), Coumarin anticoagulants, clarithromycin, erythromycin, ketoconazole and itraconazole
•Patients with 2.5 times the upper limit of Creatine kinase (CK) level
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method