A clinical study to evaluate efficacy and safety of â??Lipidil tabletâ?? in comparison with â??Atorvastatinâ?? in Patients with Dyslipidemia-An Open labeled, Randomized, Single Center, Prospective Study. - NI

Arjun Healthcare0 个研究点目标入组 80 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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.

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