EUCTR2015-005756-10-DK进行中（未招募）1 期
A Phase 2 Randomized, Double-Blind, Dose-Finding Study to Assessthe Efficacy, Safety, and Tolerability of Gemcabene in Patients withHypercholesterolemia on a High-Intensity Stable Statin Therapy(ROYAL-1) - ROYAL-1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 212
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Provision of written and signed informed consent (by patient or legal guardian) prior to any study-specific procedure;
- •2. Male or female great than or equal to 18 years of age at time of consent;
- •3. Currently on a stable, low-fat, low-cholesterol diet in combination with atorvastatin (40 mg or 80 mg QD) or rosuvastatin (20 mg or 40 mg QD) with or without ezetimibe (10 mg QD) for at least 4 weeks prior to the Screening Visit;
- •4. Fasting LDL-C value great than 100 mg/dL at the Screening Visit;
- •5. Physical examination, including vital signs, that is within normal limits or clinically acceptable to the Investigator;
- •6. Weight great than or equal to 50 kg;
- •7. Female patients must not be pregnant or lactating. Women of child-bearing potential must have
- •a negative serum pregnancy test at the Screening Visit and negative urine dipstick on Day 1 prior to dosing in order to qualify for the study. Women who are surgically sterile or are clinically confirmed to be post-menopausal (i.e., documented amenorrhea for greater than or equal to 1 year in the absence of other biological or physiological causes) are not considered to be of child-bearing potential; and
- •8. Women of child-bearing potential must agree to use acceptable methods of contraception
- •throughout the duration of the study and for 30 days after the last dose of study drug. For this
- •study, double-barrier contraception is required.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •1. Abnormal liver function test at the Pre-Screening Visit or the Screening Visit (aspartate aminotransferase or alanine aminotransferase greater than 2 × the upper limit of normal [ULN], total bilirubin greater than 1.5 × ULN, or alkaline phosphatase greater than 2 × ULN based on appropriate age and gender normal values). Patients with bilirubin greater than 1.5 × ULN and history of Gilbert’s syndrome may be
- •included; reflexive direct bilirubin testing will be used to confirm Gilbert’s syndrome;
- •2. Moderate (Grade B) or severe (Grade C) chronic hepatic impairment according to the Child-Pugh classification;
- •3. Active liver disease (e.g., cirrhosis, alcoholic liver disease, hepatitis B [HBV], hepatitis C [HCV], autoimmune hepatitis, liver failure, liver cancer), history of liver transplant, known diagnosis of human immunodeficiency virus (HIV), or acquired immune deficiency virus;
- •4. Triglyceride value greater than 400 mg/dL at the Pre-Screening Visit or the Screening Visit;
- •5. Moderate to severe renal insufficiency defined as an estimated GFR less than 30 mL/min/1.73m2 (calculated using The Chronic Kidney Disease Epidemiology Collaboration equation) at the Pre-Screening Visit or the Screening Visit;
- •6. Abnormal urinalysis (proteinuria greater than trace or any male or non-menstruating female with greater than trace hematuria), confirmed by reflexive urine protein:creatinine ratio testing;
- •7. Uncontrolled thyroid disease: hyperthyroidism or hypothyroidism as defined by thyroid-stimulating hormone (TSH) below the lower limit of normal or greater than 1.5 × ULN, respectively, based on results from the Pre-Screening Visit or the Screening Visit. If controlled, treatment should be stable for at least 3 months prior to the Screening Visit;
- •8. Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (hemoglobin A1c [HbA1c] value greater than 8% based on results from the Pre-Screening Visit or the Screening Visit), or any diabetic patient taking insulin and/or thiazolidinediones;
- •9. New York Heart Association Class III or IV heart failure (see Appendix C);
- •10. Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or other major cardiovascular events resulting in hospitalization within 3 months of the Screening Visit. Patients with adequately treated stable angina, per Investigator
- •assessment, may be included;
- •11. Uncontrolled cardiac arrhythmia or prolonged QT on the Screening Visit or Day 1 prior to dosing ECG (QTcF >450 msec for men and >470 msec for women) or known family history of prolonged QT or unexplained sudden cardiac death;
- •12. Uncontrolled hypertension, defined as sitting systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg, and confirmed by repeat measurement;
- •13. Currently receiving cancer treatments or, in the Investigator’s opinion, at risk of relapse for recent cancer;
- •14. Use of a PCSK9 inhibitor (8 weeks prior to the Screening Visit), a fibrate lipid-regulating agent (6 weeks prior to the Screening Visit), niacins (4 weeks prior to the Screening Visit), or other lipid-regulating therapies such as bile acid sequestrants (4 weeks prior to the Screening Visit);
- •15. Hypersensitivity to or a history of significant adverse reactions to any fibrate lipid-regulating agent;
- •16. Use of any excluded medications or supplements (e.g., potent cytochrome P450 [CYP] 3A4 inhibitors;
- •17. History of drug or alcohol abu
研究者
相似试验
进行中（未招募）
1 期
Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative ColitisModerate to Severe Active Ulcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856EUCTR2021-002537-41-ITAMGEN INC.320
未知
2 期
A phase 2, randomized, double-blind, dose finding study of DS-8500a in Japanese patients with type 2 diabetes mellitusType 2 Diabetes MellitusJPRN-jRCT2080223014DAIICHISANKYO Co.,Ltd.335
进行中（未招募）
1 期
Study of APD403 in the prevention of sickness caused by some chemotherapy drugsEUCTR2013-001635-51-DKAcacia Pharma Ltd315
进行中（未招募）
1 期
Study of APD403 in the prevention of sickness caused by some chemotherapy drugsEUCTR2013-001635-51-GBAcacia Pharma Ltd328
进行中（未招募）
1 期
Study of APD403 in the prevention of sickness caused by some chemotherapy drugsEUCTR2013-001635-51-DEAcacia Pharma Ltd315