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

VIVUS, Inc.0 sites16,000 target enrollmentJuly 24, 2013

Overview

No summary available.

Registry

who.int

Start Date

July 24, 2013

End Date

TBD

Last Updated

12 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;