Cardiovascular Disease in overweight and obese subjects MedDRA version: 16.0 Level: LLT Classification code 10007648 Term: Cardiovascular disease, unspecified System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Qsymia®
Pharmaceutical Form: Capsule
INN or Proposed INN: PHENTERMINE HYDROCHLORIDE
CAS Number: 1197-21-3
Current Sponsor code: 2610830
Concentration unit: mg milligram(s)
Concentration t
Sponsors
VIVUS, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the effect of long-term treatment with Qsymia on the incidence of nonfatal myocardial infarction (MI), nonfatal stroke, or cardiovascular death in overweight and obese subjects with documented cardiovascular disease (CVD).;Secondary Objective: The secondary objectives of the study are the following: • To evaluate the effect of long-term treatment with Qsymia on other cardiovascular morbidity and mortality endpoints in overweight and obese subjects with CVD; and • To evaluate the effect of long-term treatment with Qsymia on body weight and various cardiovascular and metabolic markers in comparison to placebo in overweight and obese subjects with CVD.;Primary end point(s): The primary efficacy endpoint is the time to the first occurrence of a primary outcome event: nonfatal MI, nonfatal stroke, or cardiovascular death.;Timepoint(s) of evaluation of this end point: Timepoint for evaluation of primary endpoint is the time of the the first occurrence of a primary outcome event: nonfatal MI, nonfatal stroke, or cardiovascular death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time to the first occurrence of fatal or nonfatal stroke; • Time to the first occurrence of cardiovascular death; • Time to the first occurrence of all-cause mortality; and • Time to the first occurrence of either cardiovascular death, MI, stroke, hospitalization for unstable angina, urgent revascularization, or hospitalization for HF.;Timepoint(s) of evaluation of this end point: Timepoint for evaluation of the secondary endpoint is the time of the first occurrence of the events. | — |
Countries
Chile, China, Colombia, Czech Republic, Georgia, Germany, Hong Kong, Hungary, Israel, Korea, Republic of, Malaysia, Mexico, Philippines, Poland, Romania, Singapore, Slovakia, South Africa, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trials Information
VIVUS, Inc.
Outcome results
None listed