CTRI/2022/03/041486尚未招募4 期
A prospective, single centre, double-blinded, randomised trial with an objective to evaluate the efficacy and safety of an SPC of Cilnidipine (10mg) + Telmisartan (40mg) compared to Telmisartan (40mg) and explore the effects of the SPC on renal outcomes in 200 Indian Diabetic hypertensive patients. The study drug will be Cilacar T (10/40)
JB Chemicals and Pharmaceuticals Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •To be eligible to be enrolled into the study, subjects should fulfil the following criteria.
- •1.Male or female patients aged 40 â?? 75 years with a clinical diagnosis of hypertension with diabetes (treatment Naïve patients)
- •2.BP measures at baseline (outpatient systolic/diastolic BP >= 130/80 and < 180/110 mmHg)
- •3.Diabetes status: Type 2 diabetes HbA1c levels: >6.5%
- •4.Blood glucose levels (Fasting: >126 mg/dl, Post prandial: >160 mg/dl)
- •5.With Microalbuminuria (urinary albumin to creatinine [Cr] ratio [UACR] >= 30 and < 300 mg/g in spot urine)
- •6.eGFR: >90
- •7.Patients must be able to read, understand and follow study related documents/procedures and willing to provide written informed consent
排除标准
- •To be eligible for the study, the below parameters should be ensured to be excluded:
- •Patients with Advanced renal disease (CKD stage 3,4,5, Serum creatinine: >3mg/dl), Severe hypertension (BP >=180/110mmHg, complicated hypertension (increased CV risk)
- •Elderly patients >75 years of age
- •Hypertensive emergency patients
- •Secondary hypertension.
- •Patients with history of Type I DM
- •Patients with history of liver and renal disease.
研究者
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