CTRI/2009/091/000533已完成3 期
A multi-centric, prospective, randomized, double blind study to evaluate the safety and efficacy of 2mg and 4mg of ZYH1 compared to placebo in hypertriglyceridemia with type II diabetes not controlled with Atorvastatin therapy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
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
- •1) Age 18- 65 years
- •2) Subjects of either gender, males or females
- •3) Subjects on treatment of type 2 diabetes mellitus (DM) for at least last 3 months or documented history of type 2 diabetes mellitus as per American Diabetes Association (ADA).
- •4) Patient on stable Atorvastatin therapy (10 mg) for at least 4 weeks with LDL greater than or equal to 100mg%.
- •5) Triglycerides > 200 up to 500 mg/dl on screening visit.
- •6) Body mass index (BMI) > 23 kg/m2
- •7) Subject has given informed consent for participation in this trial
排除标准
- •1) Pregnancy and lactation
- •2) History of > 5% weight loss in past 6 months
- •3) Subjects on insulin
- •4) Subjects on glitazone / glitazar therapy in the past 1 month
- •5) Subjects having unstable angina, Acute Myocardial Infarction in past 3 months or heart failure of NYHA class (III-IV).
- •6) Uncontrolled hypertension
- •7) History of clinically significant edema.
- •8) History of thyroid disorder (abnormal TSH value) or subjects on any thyroid modulating drugs
- •9) History of active liver disease or gall stones or hepatic dysfunction demonstrated by AST and ALT greater than or equal to 2.5 times of upper normal limit (UNL) or bilirubin greater than or equal to 2 times UNL.
- •10) History of myopathies or evidence of active muscle diseases demonstrated by CPK greater than or equal 10 times UNL.
- •11) History of any other concurrent serious illness ( e.g. tuberculosis, HIV, malignancy)
- •12) History of alcohol and/or drug abuse
- •13) History of known allergy, sensitivity or intolerance to the study drugs and their formulation ingredients.
- •14) Renal dysfunction demonstrated by abnormal serum creatinine levels (> 1.2 mg %) or presence of ketonuria.
- •15) Subjects on concomitant medications known to affect the lipid level other than Atorvastatin 10 mg in past 4 weeks.
- •16) History of contraceptive, hormone replacement therapy (HRT) or steroids since last 3 months.
- •17) History of long term use of Non steroidal anti- inflammatory drugs for any treatment such as osteoarthritis, rheumatoid arthritis etc.
- •18) Participation in any other clinical trial in the past 3 months
- •19) Unable to give informed consent.
研究者
相似试验
招募中
3 期
A Clinical trial to evaluate the efficacy, safety and tolerability of FDC of Dapagliflozin 10mg and Telmisartan 80mg in patients with chronic kidney diseaseCTRI/2024/04/065084ERIS LIFESCIENCES LIMITED
已完成
2 期
Study the safety and efficacy of PMZ-2010 in patients with shock due to blood loss.CTRI/2017/03/008184Pharmazz India Private Limited50
已完成
3 期
PMZ-1620 for the treatment of stroke.CTRI/2019/09/021373Pharmazz India Private Limited158
招募中
4 期
sovateltide Injection for the treatment of acute cerebral ischemic strokeCTRI/2023/12/060404Pharmazz India Private Limited
已完成
2 期
To Study the effect of PMZ-1620 in stroke patients.CTRI/2017/11/010654Pharmazz India Private Limited40