EUCTR2012-003946-34-SK进行中（未招募）1 期
A Qsymia™ CardiovascuLAr morbIdity and Mortality (AQCLAIM) Study in Subjects with Documented Cardiovascular Disease - AQCLAIM
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
- VIVUS, Inc.
- 入组人数
- 16,000
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. Age =45 years;
- •2. BMI =27 kg/m2 (=24 kg/m2 for Asians);
- •3. Waist circumference =102 cm (40 in) for men or =88 cm (35 in) for women (=90 cm [35 in] and =80 cm [31 in] for Asian men and women, respectively);
- •4. Stable body weight during the previous 2 months (±3% self reported);
- •5. Be classified into one of the following three risk categories: Stratum A (High stroke risk), Stratum B (High CVD risk) or Stratum C (Intermediate CVD risk) - Please see protocol for details.
- •6. Women of childbearing potential must be using adequate contraception, defined as a double-barrier method, stable hormonal contraception plus single barrier, or previously documented tubal ligation. Women are considered to be of childbearing potential unless they are =50 years of age with spontaneous amenorrhea for at least 12 months or have had a hysterectomy and/or bilateral oophorectomy;
- •7. Ability to understand the study procedures and provide written informed consent; and
- •8. Willingness and ability to comply with scheduled study visits and study procedures.
- •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 10000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6000
排除标准
- •To be eligible for enrollment into this study, subjects must not meet any of the following criteria:
- •1. Concurrent use of glucagon-like peptide-1 (GLP-1) analogs and all forms of insulin;
- •2. Uncontrolled hypertension (SBP >180 mmHg or DBP >100 mmHg) at the time of randomization. Subjects with uncontrolled hypertension may be re-screened once blood pressure has been controlled and the antihypertensive regimen has been stabilized for at least 2 months prior to randomization;
- •3. Congestive Heart Failure (CHF) accompanied by hypotension; New York Heart Association (NYHA) CHF Class III or greater;
- •4. Condition or disease interfering with metabolism, such as untreated hypothyroidism, Cushing’s syndrome, or type 1 diabetes;
- •5. History or presence of significant eating disorder, such as binge eating, bulimia, or anorexia nervosa;
- •6. Pheochromocytoma or carcinoid syndrome;
- •7. Renal dialysis required or severe renal impairment, defined as creatinine clearance <30 mL/min;
- •8. History or presence of potentially life-threatening cardiac arrhythmia;
- •9. History of nephrolithiasis;
- •10. Severe hepatic impairment (i.e., Child-Pugh class C);
- •11. Prior or planned surgery for weight loss, including cosmetic liposuction;
- •12. Unwillingness or inability to participate in the diet or physical activity program;
- •13. Clinically significant thyroid dysfunction as evidenced by signs or symptoms of hypothyroidism or use of thyroid hormone treatment that has not been stable for at least 3 months prior to randomization;
- •14. Use of chronic systemic glucocorticoid therapy or any other steroid hormone therapy that has not been stable for at least 3 months prior to randomization;
- •15. Prior suicide attempt or any current active suicidal ideation (i.e., suicidal ideation with some intent to act, without specific plan or active suicidal ideation with specific plan and intent);
- •16. History of major depressive disorder within the last 2 years;
- •17. History of bipolar disorder, obsessive compulsive disorder, borderline personality disorder, psychotic depression, schizophrenia, schizoaffective disorder, or any other psychotic disorder;
- •18. Current abuse of or dependence on any drug (other than nicotine), including alcohol;
- •19. History of or current treatment for seizures;
- •20. History of any malignancy within the past 5 years other than basal or squamous cell carcinomas of the skin or cervical carcinomas following curative surgical resection;
- •21. Planned revascularization or angiography during the study;
- •22. History of angle-closure glaucoma or any past or present use of medications to treat increased intraocular pressure;
- •23. Women who are pregnant, breastfeeding, or intend to become pregnant during the study;
- •24. Any of the following abnormal laboratory values (tests may be repeated per discretion of the investigator):
- •a. Bicarbonate <20 mEq/L;
- •b. Potassium <3.5 mEq/L;
- •c. Triglycerides >500 mg/dL;
- •d. HbA1c >10.0%; or
- •e. Alanine transaminase (ALT) or aspartate transaminase (AST) >3 × upper limit of normal (ULN);
- •25. History of a positive screening test for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus;
- •26. Treatment with phentermine, topiramate, lorcaserin, or any other over-the-counter (OTC) or prescription weight loss drug within 3 months of screening;
- •27. Known allergy or hypersensitivity to phentermine or topiramate or history of anaphylaxis to any drug;
- •28. Use of any investigational medication or device for a
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