NCT01539616已完成2 期
A Multicentric Prospective Randomized Double Blind Parallel Group Active Controlled Study to Evaluate the Safety and Efficacy of ZYH7 Compared to Fenofibrate in Patients With Dyslipidemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 18
- 主要终点
- Percentage change in mean triglyceride level from baseline
研究概览
简要总结
ZYH7, a novel peroxisome proliferator-activated receptor (PPAR) alpha agonist, is expected to decrease triglyceride level and also correct dyslipidemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •Subjects of either gender, males or females
- •Triglycerides between 200 to 500 mg/dl on screening visit.
- •Body mass index (BMI) > 23 kg/m2
- •If subject is diabetic, he should be controlled on a maximum of two oral anti diabetic agents except Thiazolidinedione.
- •Subject has given informed consent for participation in this trial.
排除标准
- •Pregnancy and lactation.
- •History of 5% weight loss in past 6 months.
- •Subjects on treatment with insulin and PPAR alpha or gamma agonist in the past 3 month.
- •Subjects having unstable angina, acute myocardial infarction in past 3 months or heart failure of New York Heart Association (NYHA) class (III-IV).
- •Uncontrolled hypertension (150/100 mm of Hg).(If Subject using Thiazides, ACE inhibitors, beta blockers they should be on minimum 3 month stable therapy and treatment not expected to change during trial participation)
- •History of clinically significant edema.
- •History of pancreatitis or gall stone diseases.
- •Subject having thyroid-stimulating hormone (TSH) levels outside normal reference range, Subjects who are clinically euthyroid and on stable thyroid replacement therapy for 2 months prior to screening and who are anticipated to remain on this dose throughout the trial period will be allowed.
- •Uncontrolled diabetes (HbA1c ≥ 9 gm %).
- •History of active liver disease or hepatic dysfunction demonstrated by aspartate aminotransferase (AST) and Alanine Aminotransferase(ALT) ≥ 2.5 times of upper normal limit (UNL) or bilirubin ≥ 2 times UNL in the past 3 months.
- •Renal dysfunction demonstrated by abnormal Glomerular Filtration Rate (GFR) (60 ml/min) or presence of ketonuria.
- •History of myopathies or evidence of active muscle diseases demonstrated by Creatinine Phosphokinase(CPK) ≥ 10 times UNL.
- •History of any other concurrent serious illness (e.g. tuberculosis, Human Immunodeficiency Virus(HIV) infection, malignancy, etc).
- •History of alcohol and/or drug abuse.
- •History of known allergy, sensitivity or intolerance to the study drugs and their formulation ingredients.
- •Subjects on any other lipid lowering medications. (Appendix I).
- •If on contraceptive or hormone replacement therapy (HRT), therapy started or changed in last 3 months.
- •Prolonged use of steroids (15 days) in last 3 months (topical preparations, nasal and intra-articular administration are permitted).
- •History of long term use of non-steroidal anti-inflammatory drugs. (1 month)
- •Participation in any other clinical trial in the past 3 months
- •Unable to give informed consent and follow protocol requirements.
研究组 & 干预措施
ZYH7 4mg
Experimental
ZYH7 4mg
干预措施: ZYH7 (Drug)
ZYH7 8mg
Experimental
ZYH7 8mg
干预措施: ZYH7 (Drug)
ZYH7 16mg
Experimental
ZYH7 16mg
干预措施: ZYH7 (Drug)
Fenofibrate 160mg
Active Comparator
Fenofibrate 160mg
干预措施: Fenofibrate (Drug)
结局指标
主要结局
Percentage change in mean triglyceride level from baseline
时间窗: 4 and 8 weeks
Percentage change in mean triglyceride levels from baseline within and across each treatment of ZYH7 The changes will be compared with fenofibrate 160mg.
次要结局
- Percentage change from baseline in lipid parameters(4 and 8 weeks)
研究者
研究点 (18)
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