A Double Blind, Randomized, Multicentric, Active Controlled, Parallel Group, Comparative, Phase III study to evaluate the efficacy and safety of Azelnidipine versus Amlodipine in Newly Diagnosed Patients with Mild to Moderate Essential Hypertension.

Precise Chemipharma Pvt Ltd0 个研究点目标入组 600 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 with mild to moderate Essential Hypertension with SBP ranging between 140-159 mmHg and/or DBP ranging between 90-99mmHg.
•4.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.
•5.Female subjects of child bearing potential should have negative Urine Pregnancy Test (UPT) at the time of screening.

•1.Known or suspected secondary hypertension; severe diastolic hypertension (seated diastolic BP: >114 mm Hg)
•2.Clinically significant renal (estimated glomerular filtration rate: <30 mL/min per 1.73 m2) metabolic, hepatic, or psychiatric disorders
•3.Clinically relevant or unstable cardiovascular diseases
•4.Type 1 or poorly controlled type 2 diabetes mellitus (hemoglobin A1c: >=9%).
•5.Night-shift workers
•6.Pregnant or nursing women
•7.Women of childbearing potential not using medically approved means of contraception
•8.Patients taking any concomitant medications known to affect BP.
•9.History of drug or alcohol abuse
•10.Those who smoke >1 pack of cigarettes per day
•11.Those with any medical condition judged by investigators to possibly jeopardize the evaluation of efficacy and safety of therapy were excluded from the study.

发起方

Precise Chemipharma Pvt Ltd