EUCTR2004-004881-34-GB进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, parallel-group, fixed-dose (rimonabant 20mg) multicenter study of long-term glycemic control with rimonabantin treatment-naïve patients with type 2 diabetes - SERENADE
Sanofi-Synthelabo Recherche0 个研究点目标入组 264 人开始时间: 2005年2月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 264
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female patients aged = 18 years.
- •Diagnosis of type 2 diabetes as defined by WHO criteria for at least 2 months
- •but no longer than 3 years.
- •Type 2 diabetes not previously treated by a pharmacological agent.
- •HbA1C = 7% and = 10%.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Weight loss > 5 kg within 3 months prior to screening visit.
- •Pregnancy or lactation.
- •Absence of medically approved contraceptive methods for females of childbearing potential.
- •Marijuana or hashish users.
- •Presence or history of allergic reaction or intolerance to multiple drugs.
- •Presence of any other condition (e.g. geographic, social …) actual or anticipated,
- •that the Investigator feels that would restrict or limit the patient’s participation for
- •the duration of the study.
- •No use of any oral antidiabetic agent is allowed prior to the entry of the study, except for the conditions described in the protocol.
- •No use of insulin is allowed prior to the entry of the study, except for the conditions described in the protocol.
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