A real world experience in BP reduction of Co-Diovan in Indian Setting

A 12-week, multicenter study to investigate effectiveness and safety of Valsartan-Hydrochlorthiazide in real life settings, in patients whose blood pressure (BP) was uncontrolled by monotherapy - Val-FAST

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2013/05/003659

Enrollment

500

Registered

2013-05-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Uncontrolled Hypertension

Interventions

Intervention1: Valsartan-Hydrochlorthiazide: Single arm Dosage - Minimum dose 80/12.5 mg or Maximum Dose 160/25 mg Once daily. Route of Administration Oral Control Intervention1: Not Applicable: Not A

Eligibility

Inclusion criteria

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

Exclusion criteria: Contraindications mentioned in the local prescribing information for Valsartan-Hydrochlorothiazide

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
1. Control rate at 12 weeks - % of patients with SBP 140 mmHg and DBP 90 mmHg 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) 3. To evaluate the efficacy and tolerability of Valsartan- Hydrochlorthiazide at 12 weeks based on the global assessment by the physicians and patients Timepoint: 1. Control rate at 12 weeks - % of patients with SBP 140 mmHg and DBP 90 mmHg 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) 3. To evaluate the efficacy and tolerability of Valsartan- Hydrochlorthiazide at 12 weeks based on the global assessment by the physicians and patients	—

Measure

Time frame

1. Control rate at 12 weeks - % of patients with SBP 140 mmHg and DBP 90 mmHg 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) 3. To evaluate the efficacy and tolerability of Valsartan- Hydrochlorthiazide at 12 weeks based on the global assessment by the physicians and patients Timepoint: 1. Control rate at 12 weeks - % of patients with SBP 140 mmHg and DBP 90 mmHg 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) 3. To evaluate the efficacy and tolerability of Valsartan- Hydrochlorthiazide at 12 weeks based on the global assessment by the physicians and patients

—

Countries

India

Contacts

Public ContactDr Sujatha Navin Shetty

Sir Ganga Ram Hospital, New Delhi, India

jpssawhney@yahoo.com09810059773

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026