A clinical study to evaluate efficacy and safety of ‘Lipidil tablet’ in comparison with ‘Atorvastatin’ in Patients with Dyslipidemia-An Open labeled, Randomized, Single Center, Prospective Study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To evaluate efficacy of Lipidil tablet in comparison with Atorvastatin in Patients with Dyslipidemia by assessing Lipid profile
研究概览
简要总结
Thisstudy is an Open labeled, Randomized, Single Center, Prospective clinical studyto evaluate efficacy and safety of ‘Lipidil tablet’ in comparison with‘Atorvastatin’ in Patients with Dyslipidemia. Tablet Lipidil will be given in adose of 2 tablets twice daily orally for 3 months. Atorvastatin 10 mg tablet willbe give once daily orally for 3 months. The trial will be conducted in India. 80patients (40 patients in each group) will be recruited. The primary outcomemeasures will be to evaluate efficacy of Lipidil tablet in comparison withAtorvastatin in Patients with Dyslipidemia by assessing Lipid profile (Day 0,Day 30, day 60 and day 90). The secondary objectives will be assessment of Cardiacrisk bio-markers, tolerability of study drugs by assessing ADRs on studycompletion and assessment of Laboratory parameters like Liver function tests(LFT), Renal function tests (RFT), complete blood count (CBC), ESR, Hb%, UrineExamination and ECG
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects diagnosed as Dyslipidemia (LDL-C between 130 and 190 mg/dl, Triglycerides between 150 and 500 mg/dL and TC ≥ 240 mg/dl but not more than 400 mg/dl).
- •2.Subjects ECG not demonstrating any signs of uncontrolled arrhythmia / acute ischemia.
- •3.Subjects X- ray chest not showing any active lesion of tuberculosis 4.Female patients must be postmenopausal as defined by no menstruation for at least 12 months, or surgically sterilized for at least three months prior to beginning of the study, or have a negative pregnancy test and agree to avoid pregnancy during the study and one month after the end of the study by using reliable method of contraception.
排除标准
- •1.Patients with myocardial infarction, stroke, transient ischemic attack, cardiovascular surgery or major operations within 6 months prior to screening visit.
- •2.Patients with percutaneous coronary intervention within 3 months.
- •3.Patients who have taken lipid-lowering medications including statins or any other drug(s) (Ayurveda, Unani, Siddha and Homeopathy) during 4 weeks prior to screening visit.
- •4.Patients with uncontrolled hypertension at the screening visit.
- •Patients on stable antihypertensive medication may be enrolled provided that the medications and dosage remain stable throughout the study.
- •5.Patients who are taking anticoagulants except aspirin at < 325 mg/day.
- •6.Patients with liver dysfunction as indicated by a serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) level of > 1.5-times of upper limit of normal range, or clinical symptoms.
- •7.Patients with renal dysfunction as indicated by a serum creatinine level above ULN range, or clinical symptoms.
- •8.Patients with gastric or peptic ulcer within 3 months prior to screening visit.
结局指标
主要结局
To evaluate efficacy of Lipidil tablet in comparison with Atorvastatin in Patients with Dyslipidemia by assessing Lipid profile
时间窗: Day 0, Day 30, day 60 and day 90.
次要结局
- 1.Cardiac risk bio-markers(2.Tolerability of study drugs by assessing ADRs on study completion.)