A Phase III, Randomized, Double Blind, Parallel Group, Comparative Clinical Trial to Evaluate the safety, tolerability and efficacy of 2 Fixed dose combinations of Azelnidipine and Telmisartan when compared with fixed dose combination of Amlodipine and Telmisartan in patients with Stage II hypertension. - NA

Synokem Pharmaceuticals Ltd0 个研究点目标入组 210 人开始时间: 待定最近更新: 2021年11月24日

研究概览

暂无简介。

•1.Patients of either sex aged between 18 to 75 years
•2.Signed written informed consent obtained prior to inclusion in the study.
•3.Patient diagnosed with Stage II hypertension (SBP >=160 to <=180 and DBP >=100 to <=110 mmHg))
•4.Subjects who are newly diagnosed with hypertension or Subjects who have not received anti-hypertensive medication for at least 2 weeks prior to Visit 1
•5.Subjects willing to adhere to protocol and study requirements during the entire study duration
•6.Subjects having no abnormalities in general physical examination

•1.Not willing to sign the ICF.
•2.Known or suspected secondary hypertension.
•3.Mean SBP greater than 180 mmHg.
•4.Patients with abnormal clinical chemistry, hematology, urinalysis, or ECG test results that are considered clinically significant by the investigator or the sponsor.
•5.Patients with significant hepatic disease (liver function tests x 2 upper limit of normal reference range) or significant renal disease (creatinine x 2 upper limit of normal reference range).
•6.Patients with the history of Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney.
•7.Uncorrected volume or sodium depletion or hyponatremia.

发起方