跳至主要内容
临床试验/NCT01429233
NCT01429233Unknown不适用

Real Life Experience of the Use of Isomers as ALENCAL(Levoamlodipine) for Evaluation of Efficacy, Safety and Tolerability in the Management of Cardiovascular Disease in Colombian Patients

Closter Pharma1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,000
试验地点
1
主要终点
Effect of therapy in the management of hypertension and other cardiovascular diseases

研究概览

简要总结

This is a Phase 4, observational, open study in patients whom their doctor for clinical practice prescribes levamlodipine. No medication was provided by the sponsor. The planned observation time is 8 weeks. The 8 weeks of observation involves an evaluation of baseline followed by information gathered from the assessment visits at week 4 and week 8, or clinical practice.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

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

入选标准

  • Patients whose primary physician based on their clinical condition and locally approved use will be eligible to participate in this study, and have been prescribe with Levamlodipine.

排除标准

  • 未提供

结局指标

主要结局

Effect of therapy in the management of hypertension and other cardiovascular diseases

时间窗: 8 weeks

The change from Baseline in Blood Pressure at 8 weeks will be measure to evaluate th efficacy of the therapy.

次要结局

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability(8 weeks)

研究者

发起方
Closter Pharma
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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