A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients.
Information source: Abbott
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: Sibutramine hydochloride monohydrate (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Abbott Official(s) and/or principal investigator(s):
Global Medical Information, Study Director, Affiliation: Abbott
Summary
The purpose of the study is to determine the long term impact of treating overweight and
obese patients with sibutramine who have a history of cardiovascular disease.
Clinical Details
Official title: Sibutramine Cardiovascular Morbidity/Mortality Outcomes Study in Overweight or Obese Subjects at Risk of a Cardiovascular Event
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Time from randomization to the first occurrence of any CV Outcome Event.
Secondary outcome: Time from randomization to onset of each protocol specified events; All-cause Mortality.
Eligibility
Minimum age: 55 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subject's BMI is > 27 kg/m and < 45 kg/m or their BMI is >25 kg/m and < 27 kg/m with
waist circumference of >102 cm in males or > 88 cm in females.
- Medical history positive for:
- Cardiovascular disease
- Type II Diabetes disease
Exclusion Criteria:
- History of recent myocardial infarction.
- Heart failure symptoms greater than NYHA Functional Class II.
- Hemodynamically significant valvular or left ventricular (LV) tract obstruction
- Subjects without a pacemaker and with any of the following:
- Sinus bradycardia (<50 bpm)
- Sick sinus syndrome
- AV block of more than 1st degree
- Mean sitting systolic blood pressure (SBP) >160 mmHg. Mean sitting diastolic blood
pressure DBP) > 100 mmHg. Mean sitting heart rate (HR) >100 bpm
- Syncopal episodes presumed to be due to uncontrolled life-threatening arrhythmias.
- Planned cardiac surgery or coronary angioplasty
- History of recent stroke or transient ischemic attack (TIA)
- Hyperthyroidism
- Known chronic liver disease or end stage / severe renal disease
- Severe, symptomatic benign prostatic hyperplasia which may require surgery.
- Known pheochromocytoma, narrow angle glaucoma, Gilles de la Tourette syndrome, history
of seizures, history of bariatric or abdominal obesity surgery (excluding
liposuction).
- Concomitant use of MAOIs or drugs which increase levels of serotonin in the brain.
Locations and Contacts
Global Medical Information - Abbott, North Chicago, Illinois 60064, United States
Additional Information
Starting date: December 2002
Last updated: August 30, 2007
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