A Multicentric, Randomized, Double Blind, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Azelnidipine Tablets 8 mg / 16 mg versus Amlodipine Tablets 5 mg / 10 mg in subjects with essential hypertension

Synokem Pharmaceuticals Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•1. Male or female subjects aged between 18 and 65 years (both inclusive).
•2. Treatment naïve subjects diagnosed with stage 1 essential hypertension having mean seated systolic BP (SeSBP) 140 to 159 mmHg and mean seated diastolic BP (SeDBP) 90 to 99 mmHg.
•3. Subjects with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
•4. Subjects willing to comply with the protocol requirements.

•1. Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
•2. Any surgical or medical condition which might alter the absorption, distribution, metabolism or excretion of the study drug.
•3. Has clinical laboratory evaluations (including biochemistry and hematology) are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator.
•4. Subjects with known case of secondary or malignant Hypertension.
•5. Subjects with evidence of postural hypotension (defined as drop in >20 mmHg for systolic blood pressure and >10 mmHg for diastolic blood pressure after assuming the standing posture from supine or sitting position).

发起方