An Open label Multicenter Non Interventional Observational Study to Evaluate Efficacy of Telmisartan 40 mg 80 mg Chlorthalidone 12.5 mg compared to Telmisartan 40 mg 80 mg Hydrochlorothiazide 12.5 mg and continuation of Telmisartan 40 mg 80 mg alone in Hypertensive patients not responding to four weeks of Telmisartan 40 mg 80 mg Monotherapy

Dr Reddys Laboratories Ltd0 个研究点目标入组 500 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Participants willing to sign an Informed Consent Form indicating that they understand the purpose of and the procedures required for the trial and are willing to participate in it.
•2.Male and female treatment naÃ¯ve patients, aged 18â??80 years, with diagnosis of Stage 1-2 / mild-to-moderate essential hypertension (DBP 95â??109 mm Hg and SBP 140â?? 179 mm Hg) at entry, who are considered appropriate for initial monotherapy with Telmisartan 40 mg/80 mg.
•3.Patients who have inadequate blood pressure control (DBP >90 mm Hg) but have shown atleast 2 mm DBP reduction after 4 weeks of monotherapy will be selected for treatment allocation of dual therapy or monotherapy
•NOTE â??patients with initial DBP of 95-99 mmHg generally initiated on telmisartan 40 mg and those with DBP 100-109 mm Hg initiated on telmisartan 80 mg.

•Patients already taking antihypertensive drugs at screening (since the study is intended to enroll treatment naÃ¯ve patients)
•ï?· Patients not ready to refrain from taking treatment with other drugs that could interfere with the evaluation of efficacy and tolerability.
•ï?· Patients with secondary hypertension (eg. due to renal artery stenosis etc.)
•ï?· 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]
•ï?· Patients with renal or hepatic disease (based on known history or lab abnormalities) or serum electrolyte abnormalities
•ï?· Patients with a history of angioedema
•ï?· Pregnant or breast-feeding women, and women of childbearing age not using an adequate method of contraception

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