WHO ICTRP trial

A clinical trial to evaluate efficacy and safety of fixed dose combination of…

CTRI/2015/05/005767 · Clinical Trials Registry India (CTRI) · Not Recruiting

Key facts

Trial ID CTRI/2015/05/005767
Public title A clinical trial to evaluate efficacy and safety of fixed dose combination of Losartan, amlodipine and hydrochlorothiazide in hypertensive subjects with inadequate response to dual drug therapy
Scientific title EVALUATION OF EFFICACY AND SAFETY OF FIXED DOSE COMBINATION OF LOSARTAN, AMLODIPINE AND HYDROCHLOROTHIAZIDE IN THE TREATMENT OF ESSENTIAL HYPERTENSION: AN OPEN LABEL, MULTI-CENTRIC TRIAL
Primary sponsor Sun Pharma Laboratories Limited SPLL
Registry Clinical Trials Registry India (CTRI)
Recruitment status Not Recruiting
Study type Interventional
Phase Phase 3
Countries India
Conditions Health Condition 1: null- Patient having seated diastolic BP (SeDBP) 90 to 100 mmHg and seated systolic BP (SeSBP) 140 to 200 mmHg.
Interventions Intervention1: Fixed dose combination of losartan (50mg), amlodipine (5mg) and hydrochlorothiazide (12.5mg): The recommended dosage is fixed dose combination of losartan (50mg), amlodipine (5mg) and hydrochlorothiazide (12.5mg) administered…
Registration date Dec 5, 2015
Target size 300
Secondary IDs SP/IP-108/0613
Registry page ctri.nic.in

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