Evaluation of safety and efficacy of Controlled release Hydrochlorothiazide in stage I Essential Hypertension

Comparative Evaluation of Safety and Efficacy of Hydrochlorothiazide CR with Hydrochlorothiazide and Chlorthalidone in patients with Stage I Essential Hypertension

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/07/003793

Enrollment

213

Registered

2013-07-01

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: I10- Essential (primary) hypertension

Interventions

Intervention1: Hydrochlorothiazide (controlled released)12.5 mg: Dose-Hydrochlorothiazide(controlled released-12.5 mg), Frequency-OD, Mode of administration- Oral, Duration-84 Days Control Interventio

Eligibility

Inclusion criteria

Inclusion criteria: i)patients with Systolic Blood Pressure-140-159mmHg and Diastolic Blood Pressure-90-99mmHg

Exclusion criteria

Exclusion criteria: i)patients with secondary hypertension ii) Patients with significant cardiovascular disease iii)Patients with abnormal renal, liver function iv)Patients currently uncontrolled on thiazide type diuretics v)patients who have used another investigational agent/device within last 30 days prior to enrollment vi) Patients taking concomitant medications known to alter the blood pressure or to affect the action of study drug vii) Patients with known history of hypersensitivity to study drugs or other drugs of same chemical class viii) Pregnant or lactating women or women of child-bearing potential not practicing contraception

Design outcomes

Primary

Measure	Time frame
To demonstrate comparative efficacy of Hydrochlorothiazide(controlled release)with chlorthalidone 6.25mg and also its superiority to hydrochlorothiazide 12.5mg with respect to change in 24 hr mean systolic and diastolic ambulatory blood pressure from baseline to week 4 and week 12Timepoint: 24 hr ABPM will be meausred at baseline, Week 4, and Week 12.	—

Secondary

Measure	Time frame
i)To compare change in mean office systolic and diastolic blood pressure at each visit from baseline ii)To compare change in ambulatory daytime and nighttime mean systolic and diastolic blood pressure from baseline to week 4 and week 12 iii)To assess the safety and tolerabilty of test drugs compared to reference productTimepoint: i)Office systolic and diastolic blood pressure will be measured at baseline, Day 7, Day 14, Day 28, Day 42, Day 56,Day 70,Day 84 ii)mean day-time and night-time ambulatory measurements at baseline, Week 4 and Week 12. iii) Safety and tolerability of study medications throughout the study	—

Measure

Time frame

i)To compare change in mean office systolic and diastolic blood pressure at each visit from baseline ii)To compare change in ambulatory daytime and nighttime mean systolic and diastolic blood pressure from baseline to week 4 and week 12 iii)To assess the safety and tolerabilty of test drugs compared to reference productTimepoint: i)Office systolic and diastolic blood pressure will be measured at baseline, Day 7, Day 14, Day 28, Day 42, Day 56,Day 70,Day 84 ii)mean day-time and night-time ambulatory measurements at baseline, Week 4 and Week 12. iii) Safety and tolerability of study medications throughout the study

—

Countries

India

Contacts

Public ContactNitin Chandurkar

anil.pareek@ipca.com022-66474641

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026