CTRI/2020/08/027364
Completed
Phase 3
A multicentric, randomized, double blind, parallel, comparative study to demonstrate the non-inferiority of fixed-dose combination of Efonidipine 40 mg and Chlorthalidone 12.5 mg tablets to fixed-dose combination of Cilnidipine 10 mg and Chlorthalidone 12.5 mg tablets in the management of hypertension.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Zuventus Healthcare Limited
- Enrollment
- 240
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients aged ââ?°Â¥18 years.
- •2\. Patients diagnosed with Stage\-I hypertension (SBP/DBP: 140\-159/90\-99 mmHg) or Stage\-II hypertension (SBP/DBP: ââ?°Â¥160/100 mmHg).
- •3\. Patients able to switch all prior antihypertensive medications safely to study medication (Investigatorââ?¬•s discretion).
- •4\. Patients willing to sign informed consent.
Exclusion Criteria
- •1\. Patients with known hypersensitivity to diuretics or dihydropyridine calcium channel blockers.
- •2\. Patients with history of severe, malignant or secondary hypertension.
- •3\. Patient with cerebrovascular disease in the previous 3 months.
- •4\. Patients with chronic arrhythmia, sick sinus syndrome or sinus bradycardia ( \< 50 beats/min).
- •5\. Patients with second\- or third\-degree atrioventricular block.
- •6\. Women who are pregnant, lactating
Outcomes
Primary Outcomes
Not specified
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