CTRI/2010/091/003056Other3 期
A Multicenter, Randomized, Parallel-Group, Open label Study to compare the efficacy of three strenghts of FDC containing rosuvastatin and micronized fenofibrate on lipid profile in patients with mixed dyslipidemia.
Biocon Ltd. 20th km, Hosur Road, Electronics City, Bangalore 560100, Karnataka State, India0 个研究点目标入组 160 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1.Male and female patients in the age group of 20-80 years
- •2.Subjects willing to give informed consent.
- •3.Patients with mixed dyslipidemia. The patients can be anti-lipid drug therapy naïve patients as well Statin treated patients.
- •4.Patients who were willing to comply with all study requirements
排除标准
- •1.Subjects who were currently participating or had participated in other interventional study the last 3 months prior to their enrolment.
- •2.Women who were pregnant, breast feeding or had the intention of becoming pregnant during their participation in the study.
- •3.Women of childbearing potential who were not using effective and medically acceptable methods of contraception.
- •4.Subjects who were meeting any of the contraindications of the study medication according to the approved SPC.
- •5.Known CVD, triglycerides > 500 mg/dL, renal disease (serum creatinine levels > 1.6 mg/dL), hypothyroidism [thyroid stimulating hormone (TSH) > 5 IU/mL], liver disease (ALT and/or AST 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.
- •6.Patients with diabetes will be included in the study if they are adequately controlled (HbA1c<7%) with one or 2 antidiabetic drugs (no change in their treatment will be made during the study period).
- •7.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).
- •8.Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with the assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, psychiatric, or hematological disease as determined by the clinical judgment of the investigator;
- •9.Use of any investigational drug or participation of any clinical trial within 30 days prior to this study.
研究者
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