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, India4 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2010年11月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Percentage change from baseline in LDL-C for Biocon`s FDC Rosuvastatin and Fenofibrate vs. Rosuvastatin monotherapy and fibrate monotherapy after 3 months of treatment.
研究概览
简要总结
This is a Multicenter, Randomized, Parallel-Group Study to compare the efficacy of three strenghts of FDC containing rosuvastatin and micronized fenofibrate on lipid profile in patients with mixed dyslipidemia. This study will be conducted at four centers in India. Percentage change from baseline in LDL-C will be regarded as the primary outcome of the study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
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.
结局指标
主要结局
Percentage change from baseline in LDL-C for Biocon`s FDC Rosuvastatin and Fenofibrate vs. Rosuvastatin monotherapy and fibrate monotherapy after 3 months of treatment.
时间窗: 3 months
次要结局
- The percentage of patients reaching the LDL-C target levels as per the NCEP ATP III Guideline at the end of 3 months treatment in Biocon`s FDC Rosuvastatin and Fenofibrate vs. statin monotherapy and fibrate monotherapy.(3 months)
- To compare the safety and tolerability of FDC by observing adverse events, changes in laboratory safety variables and discontinuations in Biocon`s FDC Rosuvastatin and Fenofibrate vs. statin monotherapy and fibrate monotherapy(3 months)
- To compare the percentage change in HDL-C, total cholesterol (TC) and fasting triglycerides (TG) levels from the baseline to end of 3 months therapy with Biocon`s FDC Rosuvastatin and Fenofibrate vs. statin monotherapy and fibrate monotherapy.(3 months)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
4 期
Dual RElease Hydrocortisone Versus conventionAl Glucocorticoid replaceMent Therapy in Hypocortisolism (DREAM)Primary Adrenal InsufficiencySecondary Adrenal InsufficiencyNCT02277587University of Roma La Sapienza89
已完成
3 期
24-week Trial Comparing GSK573719/GW642444 With GSK573719 and With Tiotropium in Chronic Obstructive Pulmonary DiseasePulmonary Disease, Chronic ObstructiveNCT01316913GlaxoSmithKline872
已完成
3 期
Evaluate Efficacy, Safety and PK of Adefovir Dipivoxil Liquid Suspension in Patients With Chronic Hepatitis BChronic Hepatitis BNCT00071201Gilead Sciences48
已完成
3 期
A Phase III Multicenter, Randomized Study Comparing RIT Vs ASCT in Patients With Relapsed/Refractory (FL)Relapsed Follicular LymphomaNCT01827605Fondazione Italiana Linfomi - ETS159
已完成
3 期
Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With OsteoporosisPostmenopausal Women With OsteoporosisNCT05345691Biocon Biologics UK Ltd479