CTRI/2018/12/016625
Not yet recruiting
Phase 3
A Multicentric, Randomized, Double Blind, Parallel Group, Comparative, Phase-III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination (FDC) of Efonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate Extended Release 25 mg Tablets and Efonidipine Hydrochloride Ethanolate 20 mg and Metoprolol Succinate Extended Release 50 mg Tablets Versus Efonidipine Hydrochloride Ethanolate Tablets 20 mg and Metoprolol Succinate Extended Release Tablets 50 mg Monotherapy in Subjects with Stage 2 Hypertension
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ajanta Pharma Ltd
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects meeting all of the following criteria will be recruited for the trial:
- •1\.Male or Female subjects between 18 to 65 years of age (both inclusive).
- •2\.Treatment\-Naïve subjects who are suffering from Stage 2 Hypertension.
- •3\.Subjects diagnosed with mean SBP of more than 160 to less than 180 mmHg and mean DBP more than 100 to less than 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).
- •4\.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
Exclusion Criteria
- •Subjects will be excluded if ANY of the following conditions apply:
- •1\.Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
- •2\.Subjects with known case of Secondary or Malignant Hypertension.
- •3\.Subjects with abnormal Renal Function Test.
- •4\.Subjects with abnormal eGFR will be excluded from the study.
- •5\.Subjects with known case of bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post\-renal transplant or with only one functioning kidney.
- •6\.Subjects with hyponatremia.
- •7\.Subjects with abnormal Liver Function Tests.
- •8\.Subjects with abnormal Thyroid Function Test.
- •9\.Subjects with known case of Type 1 Diabetes Mellitus will be excluded from the study.
Outcomes
Primary Outcomes
Not specified
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