CTRI/2024/07/071061尚未招募不适用
Post-approval, observational study to assess clinical safety and effectiveness of Azelnidipine and Telmisartan in management of Diabetic HTN
Torrent Pharmaceuticals Ltd.1 个研究点 分布在 1 个国家目标入组 7,000 人开始时间: 2024年8月2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
- 7,000
- 试验地点
- 1
- 主要终点
- Change from baseline in Blood Pressure (SBP/DBP) at 4W and 12W
研究概览
简要总结
The aim of this study is to assess clinical safety and effectiveness of Azelnidipine and Telmisartan in management of Diabetic HTN.
Study design: Post-approval observational study.
Duration of observation : 12 weeks
Study drug:Azelnidipine 8/16 mg and Telmisartan 20/40/80 mg
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
- •1.Male or Female patients 18 to 65 years.
- •2.Known cases of T2DM with HTN as Treatment naïve or uncontrolled receiving background ARB therapy for at least four weeks 3.Patients with systemic Blood pressure ≥140/90 mm/Hg.
排除标准
- •1.Patients with T1DM.
- •2.Patients with impaired hepatic function with liver enzymes 5X ULN 3.Current state as pregnant or breast-feeding 4.Patients not willing for follow –up during the course of the study @ 8W and 24W.
结局指标
主要结局
Change from baseline in Blood Pressure (SBP/DBP) at 4W and 12W
时间窗: Baseline, 4 weeks and 12 weeks
Change from baseline in Resting Heart Rate (RHR) at 4W and 12W
时间窗: Baseline, 4 weeks and 12 weeks
次要结局
- Change from baseline in LDL-C & Non-HDL-C levels at 4W and 12W(Baseline, 4 weeks and 12 weeks)
- Change in HbA1c at 12W.(Baseline, 4 weeks and 12 weeks)
- Change from baseline in eGFR at 4W and 12W for cases with Diabetic Kidney Disease(Baseline, 4 weeks and 12 weeks)
- Change from baseline in Blood Pressure at 4W and 12W with at least one additional risk factor (Dyslipidemia, Smoking, Family history) or Comorbidity (Left ventricular dysfunction, chronic kidney disease with proteinuria) OR 10y QRISK3 score less than 10 percentage(Baseline, 4 weeks and 12 weeks)
- Change from baseline in Resting Heart Rate at 4W and 12W for cases with 10y- QRISK3 score less than 10 percentage(Baseline, 4 weeks and 12 weeks)
研究者
Dr Jagdeep Shah
Gujrat Kidney Foundation
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
An observational study to check if Azelnidipine and Telmisartan combination is effective and safe in patients with high blood pressure.CTRI/2025/10/095717Torrent Pharmaceuticals Ltd.4,000
尚未招募
不适用
Study of azelnidipine and cilnidipine in managing type 2 diabetes with hypertensionCTRI/2024/08/071803Not applicable200
进行中（未招募）
不适用
Effects of single-pill combination of telmisartan/amlodipine and telmisartan/amlodipine/hydrochlorothiazide on 24-hour blood pressure (BP) reduction, 24-h BP variability and office BP control in patients with arterial hypertension – SATELLITE2023-504812-13-00KRKA tovarna zdravil d.d. Novo mesto, KRKA tovarna zdravil d.d. Novo mesto, KRKA tovarna zdravil d.d. Novo mesto110
尚未招募
4 期
Comparison between effect of two drugs- amlodipine and telmisartan on people with high blood pressure on their blood sugar levels,lipid rofile and renal profile.CTRI/2024/07/071545Midnapore medical college and hospital220
尚未招募
不适用
My study is about comparing the changes in blood pressure in patients having BP 140/90 to 160/100 mmHg with Vitamin D levels of 20 to 29 ng/mL taking standard of treatment which is tablet Telmisartan 40mg alone in one group and tablet Telmisartan 40mg with Vitamin D supplementation in another groupCTRI/2025/11/09759284