CTRI/2024/08/071803尚未招募不适用
Post-approval, case control analyses to assess clinical safety and effectiveness of Azelnidipine and Cilnidipine as initial -addon therapy in management of T2DM with HTN
Not applicable1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年8月13日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1) Change from baseline in Blood Pressure (SBP/DBP)
研究概览
简要总结
It is a Post-approval, case control analyses to assess clinical safety and effectiveness of Azelnidipine and Cilnidipine as initial -addon therapy in management of T2DM with HTN.
The objective of the study was to study the impact of Azelnidipine or Cilnidipine as initial addon strategy in the management HTN with T2DM while achieving the treatment goals of </=130/80 mm Hg.
Total 200 patients will be enrolled in this study.
Study drug: Subjects will be treated with either Azelnidipine 8, 16 mg or Cilnidipine 5, 10 mg administered once a day.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or Female patients with age 18 to 65 years.
- •Known cases of T2DM with HTN as Treatment naïve or uncontrolled receiving background ARB therapy for at least four weeks.
- •Patients with systemic blood pressure greater than equal 140/90 mmHg.
排除标准
- •If patient meeting any of the study exclusion criteria should be excluded from study.
- •Patients with T1DM.
- •Patients with impaired hepatic function with liver enzymes 5X ULN.
- •Current state as pregnant or breast-feeding.
- •Patients not willing for follow up during the course of the study at 4W and 12W.
结局指标
主要结局
1) Change from baseline in Blood Pressure (SBP/DBP)
时间窗: Baseline, 4W and 12W
2) Change from baseline in Resting Heart Rate (RHR)
时间窗: Baseline, 4W and 12W
次要结局
- 1) Change from baseline in LVEF.
研究者
Dr Mayur Patil
Marengo CIMS Hospital
研究点 (1)
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