A Phase 3, Randomized, Double-blind, Double-dummy, Parallel-group, Active Drug and Placebo-controlled, Safety, Efficacy and Superiority of Sibutramine IR/Topiramate XR in Overweight Adults With Comorbidities/Obesity
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 1,855
- 试验地点
- 2
- 主要终点
- Change in weight
研究概览
简要总结
A phase 3, multicenter, randomized, double-blind, double-dummy, parallel-group, active-drug- and placebo-controlled clinical trial to assess the safety, efficacy and superiority of the new fixed-dose combination sibutramine IR/topyramat XR in weight reduction in overweight adults with comorbidity(ies) or obesity
详细描述
A phase 3, multicenter, national, randomized, double-blind, double-dummy, parallel-group, active-drug and placebo-controlled, superiority clinical trial. Individuals of both sexes aged ≥18 years and ≤60 years, overweight (BMI ≥ 27kg/m2) in the presence of comorbidities (dyslipidemia, systemic arterial hypertension [SAH], pre-diabetes and/or sleep apnea) or obese (BMI ≥ 30kg/m2 and < 45kg/m2).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female volunteers aged between 18 and 60 years (inclusive);
- •BMI ≥ 27kg/m2 and < 45kg/m
- •Patients with a BMI ≥ 27kg/m2 and < 30kg/m2 must have at least one of the following comorbidities to be included in the study: dyslipidemia, systemic arterial hypertension (SAH), pre-diabetes (fasting glucose ≥ 100mg/dL and < 126 mg/dL and/or HbA1c ≥ 5.7% and < 6.5%] and/or sleep apnea (confirmed by polysomnography performed up to three months before enrollment in the study);
- •Women of childbearing age must use adequate contraceptive methods;
- •Volunteers willing and able to comply with all aspects of the protocol;
- •Signing the Informed Consent Form (ICF) before performing any study procedure.
排除标准
- •Participation in a lifestyle change program within the three months prior to the start of the study;
- •Treatment with drugs (prescription or over-the-counter) or alternative drugs intended to promote weight loss within the three months prior to the start of the study. These medications include, among others: liraglutide, orlistat, sibutramine, topiramate, naltrexone, bupropion, sertraline, fluoxetine, duloxetine. Note: The use of metformin or other hypoglycemic drugs prescribed for the treatment of polycystic ovary syndrome or prevention of diabetes is not permitted;
- •Treatment with drugs known to cause significant weight gain within three months of starting the study. These medications include, among others: corticosteroids, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers (such as imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, lithium).
- •Presence of diabetes mellitus;
- •History of coronary artery disease (angina, history of myocardial infarction);
- •Congestive heart failure;
- •History of tachycardia;
- •History of peripheral obstructive arterial disease;
- •History of arrhythmia;
- •History of cerebrovascular disease (stroke or transient ischemic attack);
- •Inadequately controlled systemic arterial hypertension (> 145/90 mmHg);
- •History or active pulmonary arterial hypertension;
- •History or presence of eating disorders such as bulimia and anorexia;
- •Moderate or severe renal impairment (estimated creatinine clearance < 70 mL/min);
- •Hepatic failure Child-Pugh categories B or C (Child-Pugh scale score ≥ 7 points);
- •Current use of monoamine oxidase inhibitors (MAOIs) or any other drug treatment for psychiatric disorders;
- •History of psychiatric disorder requiring previous drug treatment;
- •Glaucoma or high intraocular pressure;
- •Unstable thyroid disease or replacement therapy;
- •Hypersensitivity to sibutramine, topiramate, or to any component of the investigational product formulation;
- •Known hypersensitivity to any component of the investigational drug formulation;
- •Urinary lithiasis;
- •Pregnancy or lactation;
- •Any medical or other condition that, in the opinion of the investigator(s), prevents the participant from participating in the clinical trial, such as significantly abnormal laboratory results or any physical or mental condition that prevents compliance with the protocol.
研究组 & 干预措施
Experimental drug (Sibutramine IR 15mg / Topiramate XR 75mg)
ADF1 Group Eurofarma drug association of sibutramine IR 15mg / topiramate XR 75mg
干预措施: ADF1 Group Eurofarma drug association of Sibutramine IR 15mg / Topiramate XR 75mg (Drug)
Experimental drug (Sibutramine IR 15mg / Topiramate XR 100mg)
ADF2 Group Eurofarma drug association of sibutramine IR 15mg (Sibus®) Topiramate XR 100mg from Eurofarma Laboratórios S.A..
干预措施: ADF2 Group Eurofarma drug association of Sibutramine IR 15mg / Topiramate XR 100mg (Drug)
Sibus (Sibutramine 15mg)
SIB Group Sibutramine 15mg
干预措施: SIB Group Sibus (Sibutramine) 15mg (Drug)
Placebo Group
Placebo Group
干预措施: Placebo Group (Drug)
结局指标
主要结局
Change in weight
时间窗: 58 weeks
The difference in mean percent body weight loss between the ADF sibutramine IR/topiramate XR group and the placebo-treated group is ≥5% in favor of ADF.
The mean percentage loss of body weight
时间窗: 58 weeks
The mean percentage loss of body weight in the ADF sibutramine IR/topiramate XR group was greater than that observed in the group treated with sibutramine IR
次要结局
- Proportion of participants with weight reduction ≥ 5%(58 weeks)
- Proportion of participants with weight reduction ≥ 10%(58 weeks)
- Abdominal circumference(58 weeks)
- Proportion of participants with weight reduction ≥ 15%(58 weeks)