A Qsymia™ CardiovascuLAr morbIdity and Mortality (AQCLAIM) Study in Subjects with Documented Cardiovascular Disease - AQCLAIM

VIVUS, Inc.0 sites16,000 target enrollmentNovember 7, 2013

Overview

No summary available.

Registry

who.int

Start Date

November 7, 2013

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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:

•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;