Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes
- Conditions
- -E669 Obesity, unspecifiedObesity, unspecifiedE669
- Registration Number
- PER-053-08
- Lead Sponsor
- sanofi-aventis Recherche & Development,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The diagnosis of fatal MI or fatal stroke is based on the following:<br>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.<br>Measure:The first occurrence of any myocardial infarction, any stroke, cardiovascular death<br>Timepoints:During and after the study<br>
- Secondary Outcome Measures
Name Time Method