A real world experience in BP reduction of Co-Diovan in Indian Setting
Phase 4
Completed
- Conditions
- Health Condition 1: null- Uncontrolled Hypertension
- Registration Number
- CTRI/2013/05/003659
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
Inclusion Criteria
Patients with essential hypertension >=18 years old, of either gender, who have been prescribed Valsartan-Hydrochlorthiazide based therapy according to local prescribing information in an out-patient setting
Exclusion Criteria
Contraindications mentioned in the local prescribing information for Valsartan-Hydrochlorothiazide
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of Valsartan-Hydrochlorthiazide based therapy in adult patients whose blood pressure (BP) was uncontrolled by monotherapy by means of change in mean sitting blood pressure (diastolic & sitting systolic) at 12 weeks from baseline.Timepoint: To evaluate the efficacy of Valsartan-Hydrochlorthiazide based therapy in adult patients whose blood pressure (BP) was uncontrolled by monotherapy by means of change in mean sitting blood pressure (diastolic & sitting systolic) at 12 weeks from baseline.
- Secondary Outcome Measures
Name Time Method 1.Control rate at 12 weeks - % of patients with SBP 140 mmHg and DBP 90 mmHg <br/ ><br>2.Control rate at 12 weeks according to Indian practice based on JNC VII (% of patients with SBP 140 mmHg and DBP 90 mmHg for non diabetics and SBP 130 mmHg and DBP 80 mmHg for diabetics) <br/ ><br>3.To evaluate the efficacy and tolerability of Valsartan- Hydrochlorthiazide at 12 weeks based on the global assessment by the physicians and patients <br/ ><br>Timepoint: 1.Control rate at 12 weeks - % of patients with SBP 140 mmHg and DBP 90 mmHg <br/ ><br>2.Control rate at 12 weeks according to Indian practice based on JNC VII (% of patients with SBP 140 mmHg and DBP 90 mmHg for non diabetics and SBP 130 mmHg and DBP 80 mmHg for diabetics) <br/ ><br>3.To evaluate the efficacy and tolerability of Valsartan- Hydrochlorthiazide at 12 weeks based on the global assessment by the physicians and patients <br/ ><br>