CTRI/2011/12/002303已完成3 期
A multicentric, comparative, controlled, open label, randomized, parallel-group, Phase III study to evaluate the safety and efficacy of fixed dose combination containing rosuvastatin calcium with olmesartan medoxomil versus mono-therapy for hypertension in dyslipidemic patients.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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
研究者
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