Comparison of efficacy and safety of azilsartan and chlorthalidone combination with telmisartan and chlorthalidone combination in hypertensive patients
Phase 3
- Conditions
- Health Condition 1: I10- Essential (primary) hypertension
- Registration Number
- CTRI/2022/10/046559
- Lead Sponsor
- AIIMSBhubaneswar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Hypertensive patients who had not achieved target BP level
Willing to participate by giving a written informed consent.
Exclusion Criteria
Patients diagnosed with secondary hypertension
Patients of hypertensive emergency and hypertensive urgency
Presence of hyperkalaemia (potassium level >= 5.5 mEq)
Pregnant and lactating women
Patient history of allergic to Azilsartan, Telmisartan, and Chlorthalidone
Any serious hepatic, cardiovascular, renal or pulmonary condition which may prevent participation in the study
Any drug having adverse interaction with azilsartan, telmisartan, and chlorthalidone in term of safety and efficacy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br/ ><br>To evaluate and compare the change in blood pressure (systolic and diastolic) from baseline at 12 weeks in both the groupsTimepoint: At baseline and 12 weeks
- Secondary Outcome Measures
Name Time Method â?¢To evaluate and compare the proportion of patients who achieved blood pressure target ( 140/90 mmHg in all patients with hypertension without comorbidities and 130 mm Hg of systolic blood pressure in high risk patients) after 12 weeks of therapy <br/ ><br>â?¢To evaluate and compare the changes in serum urea, serum creatinine, lipid profile after 12 weeks of therapy. <br/ ><br>â?¢To compare treatment-emergent adverse events of the two treatment groups. <br/ ><br>â?¢To compare the treatment satisfaction in both the groups after 12 weeks of therapy. <br/ ><br>Timepoint: At baseline and 12 weeks