PER-053-08已完成未知
Randomized, Multinational, Multicenter, Double-blind, Placebo-controlled, Two-arm Parallel Group Trial of Rimonabant 20 mg OD for Reducing the Risk of Major Cardiovascular Events in Abdominally Obese Patients With Clustering Risk Factors
sanofi-aventis Recherche & Development,0 个研究点目标入组 0 人开始时间: 2008年7月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 55 至 0（—）
入选标准
- •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
排除标准
- •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
研究者
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