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Clinical Trials/CTRI/2019/07/020126
CTRI/2019/07/020126
Not Applicable
Phase 3

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 sites0 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Synokem Pharmaceuticals Ltd
Status
Not Applicable
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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).

Outcomes

Primary Outcomes

Not specified

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