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

Phase 3

Completed

• Conditions: Essential (primary) hypertension,

• Registration Number: CTRI/2013/07/003793
• Lead Sponsor: Ipca Laboratories Ltd Mumbai

Brief Summary

This is a randomized, comparative, double blind, double dummy, parallel group, multicentric study comparing efficacy and safety of Hydrochlorothiazide CR with Conventional Hydrochlorothiazide and Chlorthalidone in Patients with Stage 1 Essential Hypertension.The primary objective is to demonstrate that Hydrochlorothiazide CR 12.5 mg is as effective as Chlorthalidone 6.25 mg and is superior to Conventional Hydrochlorothiazide 12.5 mg with respect to change in 24-hr mean systolic (SBP) and diastolic (DBP) ambulatory BP from baseline to Week 4 and Week 12.The secondary objective is to compare the change in mean office SBP and DBP at each visit from baseline, to compare the change in ambulatory daytime and nighttime mean SBP and mean DBP from baseline to Week 4 and Week 12 and to assess the safety and tolerability of the test product as compared to the reference product

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-17
• Study Completion: 2015-12-05
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 213

Inclusion Criteria

i)patients with Systolic Blood Pressure-140-159mmHg and Diastolic Blood Pressure-90-99mmHg.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 12	24 hr ABPM will be meausred at baseline, Week 4, and Week 12.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (16)

Dr Kamal Sharma Cardiology Clinic; 🇮🇳 Ahmadabad, GUJARAT, India

Dr.S.N.Medical College and MDM Hospital; 🇮🇳 Jodhpur, RAJASTHAN, India

GSVM Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

Heart First Cardiac and Vascular Centre; 🇮🇳 Surat, GUJARAT, India

Indira Gandhi Medical college; 🇮🇳 Shimla, HIMACHAL PRADESH, India

IPGMER and SSKM Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

K R Hospital; 🇮🇳 Mysore, KARNATAKA, India

KEM Hospital Research Centre, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Kerala Institute of Medical Science; 🇮🇳 Thiruvananthapuram, KERALA, India

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

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Dr Kamal Sharma Cardiology Clinic

🇮🇳Ahmadabad, GUJARAT, India

Dr Kamal Sharma

Principal investigator

09426020154

kamalsharma1975@rediffmail.com