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临床试验/CTRI/2018/02/011727
CTRI/2018/02/011727已完成4 期

An Open label Multicenter Non Interventional Observational Study to Evaluate Efficacy of Telmisartan 80 mg Amlodipine 10 mg or 5mg and Chlorthalidone 12.5 mg compared to continuation of Telmisartan 80 mg and Amlodipine 10 mg or 5mg Dual therapy in Hypertensive patients not responding to four weeks of Telmisartan 80 mg and Amlodipine 10 mg or 5mg Dual Combination therapy

Dr Reddys Laboratories Ltd0 个研究点目标入组 600 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
600

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • 1. Male and female treatment naïve patients, aged 18â??80 years, with diagnosis of Stage II essential hypertension (DBP 100â??114 mm Hg and SBP 160â??199mm Hg) at entry, who are considered appropriate for initial dual therapy with Telmisartan 80 mg+ Amlodipine 5mg/ 10 mg
  • 2. Patients who have inadequate blood pressure control (DBP >90 mm Hg) but have shown atleast 2 mm DBP reduction after 4 weeks of dual therapy will be selected for treatment allocation of triple therapy or dual therapy
  • NOTE â??patients with initial DBP of 100-109mmHg generally initiated on telmisartan 80 mg + Amlodipine 5mg and those with DBP 110-114 mm Hg initiated on telmisartan 80 Mg + amlodipine 10mg.

排除标准

  • 1. Patients already taking antihypertensive drugs at screening (since the study is intended to enroll treatment naïve patients)
  • 2.Patients not ready to refrain from taking treatment with other drugs that could interfere with the evaluation of efficacy and tolerability.
  • 3.Patients with secondary hypertension (eg. due to renal artery stenosis etc.)
  • 4.Patients with uncontrolled diabetes mellitus, significant cardiovascular or cerebrovascular disease [congestive heart failure (New York Heart Association class III/IV); unstable angina in the previous 3 months; stroke within the previous 6 months; myocardial infarction, cardiac surgery, or percutaneous transluminal coronary angiography in the previous 3 months; cardiac arrhythmia; cardiomyopathy; aortic or mitral valve stenosis]
  • 5.Patients with renal or hepatic disease (based on known history or lab abnormalities) or serum electrolyte abnormalities

研究者

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