A Multicentric, Randomized, Double Blind, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Azilsartan Medoxomil 40 mg plus Cilnidipine 5 mg Tablets and FDC of Azilsartan Medoxomil 40 mg plus Cilnidipine 10 mg Tablets versus Azilsartan Medoxomil Tablets 40 mg and Cilnidipine Tablets 10 mg monotherapy in subjects with stage 2 hypertension

Synokem Pharmaceuticals Ltd0 sites228 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

January 18, 2020

Last Updated

4 years ago

Study Type

Interventional

Sponsor

•1\. Male or female subjects aged between 18 and 65 years (both inclusive).
•2\. Treatment naÃ¯ve subjects diagnosed with stage 2 hypertension having mean seated SBP of \>\=160 to \<\=180 mmHg and mean seated DBP \>\=100 to \<\=110 mmHg (3 readings will be taken by validated automated blood pressure machine in sitting position, first reading will be taken after 15 min. rest and subsequent two readings will be recorded at the interval of 2 min. each).
•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).