An Open Label, Three Arm, Randomized, Prospective, Multicentric, Phase III Clinical study to evaluate and compare the efficacy and safety of Azilsartan Medoxomil Tablets 20mg, Azilsartan Medoxomil 40mg & Azilsartan Medoxomil 80mg with Telmisartan Tablets 20mg & 40mg in Indian Adults patients of Essential hypertension with or without associated Cardiovascular Complications - AZTE

MSN Laboratories Pvt Ltd0 个研究点目标入组 255 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.Male or female patients of age between 18-65 years.
•2.Patients or patientâ??s legally acceptable representative willing to sign the Informed Consent Form.
•3.Patients newly diagnosed (first-time diagnosis during screening or within three months before the first day of screening) with Essential Hypertension of Stage 1 with SBP ranging between 140 159 mmHg and / or DBP ranging between 90-99 mmHg.
•4.Patients currently:
•a) on anti-hypertensive drug therapy (for phase A as well as phase B) or
•b) without anti-hypertensive drug therapy (for phase B only)
•5.Female patients of childbearing potential who are sexually active must agree to use adequate contraception, and should neither be pregnant nor lactating from screening throughout the duration of the study
•6.Patients willing and able to participate in all aspects of the core study, including use of oral medication, completion of subjective evaluations, and compliance with protocol requirements.
•7.Patients willing to discontinue current anti-hypertensive drug therapy (if applicable).

•1.Patients (essentially â??newly diagnosedâ??) who will be at a significant medical risk arising out of deprivation of regular anti-hypertensive drug treatment during the washout period.
•2.Patients with a history of chronic kidney disease, renal artery stenosis, excessive aldosterone secretion, pheochromocytoma, or sleep apnea.
•3.Patients with severe renal impairment (eGFR <60 mL/min/1.73 m2).
•4.Patients with severe hepatic impairment [SGOT, SGPT and S. Bilirubin (total) >=1.5 times the upper limit of normal reference values].
•5.Patients with history of hyperkalemia.
•6.Patient with known history of unstable cardiovascular disease and/or signiï¬?cant cardiac conduction defects.
•7.Patient with Type 1 or Type 2 Diabetes Mellitus.
•8.Known history of gout.
•9.Patients suffering from pre-existing severe cough.
•10.Patients with history of cardiac surgery in past 3 months prior to screening.
•11.Known or suspected hypersensitivity to any drug that will be administered during the study.
•12.Inability to comply with the protocol requirements.
•13.Participation in any other clinical trial within 3 months of registering in this trial.
•14.Have any condition or situation that, in the opinion of the investigator, would prevent proper evaluation of the safety of the study drug according to the study protocol.

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