EUCTR2015-004275-70-PT进行中（未招募）1 期
Influence of single nucleotide polymorphisms of carboxypeptidase D (CPD) gene on body weight and fat mass reduction by perindopril in obese subjects: A phase II, multicenter, double-blind study. - Not applicable
Gene PreDiT SA0 个研究点目标入组 160 人开始时间: 2015年12月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
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
- •Written informed consent;
- •Man or woman with 18 years or more;
- •Body Mass Index (BMI) between 30.0 to 40.0 kg/m2;
- •Willingness and ability to comply with the study requirements;
- •Ability to understand and sign informed consent;
- •If woman of childbearing potential, she agrees to adopt an effective contraceptive method.
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Pregnant or breastfeeding women;
- •History of obesity with a known cause (e.g., hypothyroidism, Cushing's disease);
- •Under treatment with perindopril or other angiotensin converting enzyme (ACE) inhibitor, or with an angiotensin receptor blocker (ARB) or a renin inhibitor;
- •Hypertension diagnosed at screening;
- •Significant variation in weight (>10%) in the past 3 months before screening visit;
- •History of anorexia nervosa, bulimia, or binge-eating disorder;
- •Systolic blood pressure <110 mmHg;
- •History of hypersensitivity to perindopril, or other ACE inhibitors, or to any of the inactive ingredients;
- •History of angioedema associated with previous ACE inhibitor therapy;
- •History of idiopathic or hereditary angioedema;
- •Treatment with concomitant medication affecting weight loss (e.g. metformin) starting within the 3 months prior to screening;
- •Treatment with concomitant medication that might interfere with the absorption, distribution, metabolism or elimination of perindopril, or, is likely to compromise the safety of subject (e.g. diuretics in patients with salt and/or volume depletion, insulin or oral antidiabetics in patients prone to develop hypoglycemic episodes, lithium, vasodilators in patients prone to develop hypotension, tricyclic antidepressants, antipsychotics, anesthetics, gold, potassium supplements or potassium-containing salt substitutes);
- •Treatment with any investigational drug or device within 1 month before the start of the run-in period;
- •Moderate to severe hepatic impairment (Child-Pugh score = 7) or moderate to severe renal impairment (glomerular filtration rate (GFR) = 59 ml/min);
- •Unstable coronary artery disease;
- •Aortic and mitral valve stenosis / hypertrophic cardiomyopathy
- •Hemodialysis patients;
- •Kidney transplantation;
- •Anaphylactoid reactions during low-density lipoproteins (LDL) apheresis;
- •Neutropenia/agranulocytosis/thrombocytopenia/Anemia;
- •Patients undergoing major surgery or during anesthesia with agents that produce hypotension;
- •Hyperkalemia;
- •Any other condition or therapy that the study physician considers to make the subject unsuitable for this study.
研究者
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