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>
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What is the mechanism of action of Valsartan-Hydrochlorthiazide in reducing blood pressure in uncontrolled hypertension patients in the CTRI/2013/05/003659 trial?
How does the combination of Valsartan and Hydrochlorthiazide compare to other antihypertensive therapies in effectiveness and safety for Indian patients with uncontrolled hypertension?
Are there specific biomarkers that can predict patient response to Valsartan-Hydrochlorthiazide combination therapy in the context of the CTRI/2013/05/003659 trial?
What are the known or potential adverse events associated with Valsartan-Hydrochlorthiazide in real-world settings, and how can they be managed effectively?
What are the related compounds or competitor drugs to Valsartan-Hydrochlorthiazide in the treatment of uncontrolled hypertension, and how do they differ in therapeutic approach?