临床试验/NCT00600067

NCT00600067已完成2 期

A Randomized, Double Blind Multicenter Study to Evaluate the Long-term Safety and Efficacy of VI-0521 Relative to Placebo in Providing and Maintaining Glycemic Control in Type 2 Diabetic Adults

VIVUS LLC1 个研究点分布在 1 个国家目标入组 130 人开始时间: 2008年1月最近更新: 2012年9月10日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: VIVUS LLC
入组人数: 130
试验地点: 1
主要终点: HbA1c Change From Baseline Week 0 to Week 56

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of the study is to determine the long-term safety and efficacy of VI-0521 (phentermine/topiramate) compared to placebo in providing blood sugar control in Type 2 diabetic adults. Continuation of initial 6 month trial.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Have completed the qualifying OB-202 trial
•If females of child-bearing potential, subjects must be using adequate contraception
•Provide written informed consent
•Be willing and able to comply with scheduled study visits, treatment plan, lab tests and other study procedures

排除标准

•Subjects who have developed one or more morbidities during the OB-202 trial that would pose a safety concern

研究组 & 干预措施

1

Experimental

干预措施: Phentermine/Topiramate (Drug)

2

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

HbA1c Change From Baseline Week 0 to Week 56

时间窗: Baseline to 56 weeks

次要结局

Percent Weight Loss From Baseline to Week 56(Baseline to 56 weeks)

研究者

发起方

VIVUS LLC

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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