None listed
Conditions
Interventions
Group 1 Type of group
(rimonabant 20 mg): administration once a day in the morning of a tablet containing 20 mg of active rimonabant
Group name:Group 2 Type of group
(rimonabant placebo) administration once a day in the morning of a rimonabant placebo tablet
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Age
55 Years to No maximum
Inclusion criteria
Inclusion criteria: • Obtain written informed consent. • Men and women 55 years of age or older • Presence of abdominal obesity with abdominal perimeter greater than 102 cm (40 inches) in men and greater than 88 cm (35 inches) in women in three successive measurements at baseline, • Presence of at least one risk equivalent for coronary heart disease (CHD) or two major cardiovascular risk factors
Exclusion criteria
Exclusion criteria: • Obesity due to an endocrine disorder known as hypothyroidism, or hypopituitary disease or another endocrine disease; • Pregnant or nursing women: breastfeeding or women who plan to become pregnant or breastfeed • Very low caloric intake (1200 calories per day or less) or surgical intervention for weight loss (eg Staples in the stomach, bypass, etc.), within 6 months of the baseline visit • Presence of any severe medical condition or advanced age, so that the patient is not expected to survive during the follow-up period planned for the study • Presence of any severe medical or psychological condition that, in the opinion of the investigator, could compromise the patient´s safe participation, including serious uncontrolled psychiatric illness such as major depression, suicidal ideation and medical history of suicide attempts. • Presence of any condition (medical, psychological, social or geographical), real or anticipated that the researcher considers to restrict or limit the successful participation of the patient throughout the study • Reception of any treatment under investigation (medication or device) within 30 days prior to the baseline visit • Previous participation in a study with rimonabant • Known allergy to rimonabant or excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The diagnosis of fatal MI or fatal stroke is based on the following: death occurred within 28 days after the onset of acute MI or stroke in the absence of another clear cause, or death occurred more than 28 days after the onset of acute MI or stroke, which according to the best clinical criteria and / or CEC it was determined to cause MI or stroke, as appropriate, or confirmation by autopsy of an acute MI or stroke as a cause of death. Measure:The first occurrence of any myocardial infarction, any stroke, cardiovascular death Timepoints:During and after the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Based on the Definitions of the American College of Cardiology (ACC) to measure results. Measure:The first occurrence of any myocardial infarction Timepoints:During and after the study ; Outcome name:Defined as an acute neurological vascular event with focal signs that last more than 24 hours with or without evidence of primary intracranial hemorrhage (PICH). Cerebrovascular accidents will also be classified as ischemic, hemorrhagic or of uncertain type. Measure:The first occurrence of any stroke Timepoints:During and after the study ; Outcome name:Death occurred in the 28 days following the onset of acute MI or stroke in the absence of another clear cause, or death occurred more than 28 days after the onset of acute MI or stroke, which according to the best clinical criteria and / or CEC it was determined to cause MI or stroke, as appropriate, or confirmation by autopsy of an acute MI or stroke as a cause of death. Measure:The first occurrence of cardiovascular death Timepoints:Durng and after treatment ; Outcome name:For any of the following: unstable angina, transient ischemic attack, heart rhythm disorder, congestive heart failure, syncope or urgent revascularization procedure. Measure:Hospitalization due to cardiovascular causes Timepoints:During and after treatment | — |
Countries
Belgium, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Ireland, Italy, Peru, Portugal, Spain, Sweden, United Kindgdom
Contacts
Public ContactSandra Mendez
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed