KCT0005394尚未招募不适用
A Multi-center, Randomized, Active-controlled, Parallel Design, Low-Intervention Clinical Trial; Pitavastatin Comparing with Atorvastatin in Patients with Pre-Diabetes Mellitus and Hypercholesterolemia for evaluate the New Onset Diabetes Mellitus (PIANO-DM study)
The Catholic University of Korea, Bucheon St. Mary's Hospital0 个研究点目标入组 706 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 706
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational Study
入排标准
- 年龄范围
- 19(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1) Age 19~75 years as of the date of written consent 2)
- •Hypercholesterolemia Patients who need to treat with Pitavastatin or
- •Atorvastatin 3) Patients who meet the below cliteria -100 mg/dL = Fasting plasma
- •glucose (FPG) = 125 mg/dL or 5.7% = HbA1c = 6.4% - Triglyceride (TG)
- •< 400 mg/dL & Low density lipoprotein-cholesterol (LDL-C) 4) Patients who are
- •willing to participate in the Low-Intervention Clinical Trial and signed an
- •infromed consent document 5) Patients who are willing and able to adhere to the
- •prohibitions and restrictions specified in this protocol
排除标准
- •1) Those with statin dosage within six months from the time
- •of screening (Visit 1) 2) A person whose medical history or surgical/procedural
- •has been verified: (1) Unstable angina occurring within 12 weeks from the time
- •of screening; myocardial infarction, routine ischemia, cerebrovascular disease
- •(e.g., stroke, cerebral infarction, cerebral hemorrhage, etc.) coronary bypass
- •or coronary interventions (2) Muscle disease, rhabdomyolysis (3) Alcohol or drug
- •abuse within one year from the time of screening (Visit 1) (4) Malicious tumors
- •within five years from the time of screening (Visit 1) 3) The following
- •accompanying diseases and laboratory tests are accompanied by abnormalities: (1)
- •FPG = 126 mg/dL or HbA1c = 6.5% (2) Systolic blood pressure (SBP) = 180
- •which is not controlled by medication mmHg or dynamic blood pressure (DBP) = 110
- •mmHg) (3) Thyroid-stimulating abnormalities that are not controlled by
- •medication hormone (TSH) = 2 X organ normal (ULN) or TSH < 0.5 X organ
- •normal, LLN (4) Creatine kinase (CK) = 2 X ULN (5) Serum creatinine = 2 X ULN
- •(6) Aspartate aminotransferase (AST) or Alan aminotransferase (ALT) = 3 X ULN
- •(7) Biliary obstruction or bile lump (8) Muscle disease 4) A person who is
- •administering cyclosporin, glycarprebir or fibrentasbir 5) Those who are
- •expected to take/take the following medication/food during the test period,
- •including the screening period (see 6.3.2 Prohibition and Prohibition for
- •details) (1) Pitavastatin or Atorvastatin and other lipid modulators (2) Any
- •other drug or food that may affect lipids in the blood; (3) Diabetes medicine
- •(but taboo before diabetes) (4) Any drug known to have drug interactions with
- •other Pitavastatin or Atorvastatin. 6) A person who has been given another test
- •medication or applied a medical device within 12 weeks from the time of
- •screening (Visit 1) 7) A person who is hypersensitive to Pitavastatin or
- •Atorvastatin or its constituent components. 8) Patients with digestive vaginosis
- •(cron disease, peptic ulcer, acute or chronic pancreatitis, etc.) that can
- •affect the absorption of Pitavastatin or Atorvastatin, or who have a history of
- •gastrointestinal surgery (except simple appendectomy or hernia surgery) 9)
- •Patients with genetic problems such as galactose intolerance, Lap lactase
- •deficiencies, or glucose-galactose malabsorbtion. 10) Pregnant women and men who
- •do not agree with the pregnant or breastfeeding and the proper contraception*. *
- •Contraception: 1.Inertation of intramuscular devices or intrauterine systems;
- •2.double-blocking (killers and condoms); contraceptive vaginal membrane, vaginal
- •sponge or cervical cap, 3. Infertility procedures (jerial joint surgery,
- •two-sided intubation, etc.) 11) Other test takers find it difficult to perform
- •the low-medium load test.
研究者
相似试验
已完成
3 期
A Phase III study understand the,Efficacy, Safety and Tolerability Study of Sugammadex Injection 100mg/ml as compared with Neostigmine Methylsulfate Injection 0.5mg/ml in subjects scheduled for surgical procedure with Shallow Neuromuscular BlockadeCTRI/2021/08/035471BDR Pharmaceuticals Internationals Pvt Ltd
终止
不适用
Phase IV Clinical Trial to Evaluate in Children with Symptom Contral due to Persistent Allergic RhinitisDiseases of th respiratory systemKCT0000972Dong Hwa Pharm100
招募中
3 期
A clinical study to evaluate the efficacy and safety of Combination of Netarsudil and Latanoprost in Comparison with Latanoprost in Patients with Glaucoma or Eye HypertensioCTRI/2021/02/031337Sun Pharmaceutical Industries Limited
进行中（未招募）
1 期
Clinical study investigating efficacy and safety of BT524 in intra-operative use in patients undergoing major spine surgeryElective spine surgery with expected major blood lossMedDRA version: 20.0Level: PTClassification code 10051125Term: HypofibrinogenaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2017-001163-20-BEBiotest AG200
进行中（未招募）
1 期
Clinical study investigating efficacy and safety of BT524 in intra-operative use in patients undergoing major spinal or abdominal surgeryEUCTR2017-001163-20-DEBiotest AG220