A Phase III clinical study to compare efficacy and safety of Efonidipine and Telmisartan combination when compared to Cilnidipine and Telmisartan combination in patients with Stage II hypertension.
- Conditions
- Health Condition 1: I10- Essential (primary) hypertension
- Registration Number
- CTRI/2020/12/029739
- Lead Sponsor
- Zuventus Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 240
1. Adults (aged >=18 years) treatment naïve patients.
2. Patients diagnosed with Stage-II hypertension (SBP/DBP: >=160/100 mmHg)
3. Patients willing to sign informed consent
1. Patients with known hypersensitivity to angiotensin II receptor blockers 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. Female patients who are pregnant, lactating.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method