EVALUATION OF EFFICACY AND SAFETY OF FIXED DOSE COMBINATION OFLOSARTAN, AMLODIPINE AND HYDROCHLOROTHIAZIDE IN THE TREATMENTOF ESSENTIAL HYPERTENSION: AN OPEN LABEL, MULTI-CENTRIC TRIA

Sun Pharma Laboratories Limited SP0 个研究点目标入组 300 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Male or female patient aged between 18 and 70 years.
•2. Patient had seated diastolic BP (SeDBP) 90 to 100 mmHg and seated systolic BP
•(SeSBP) 140 to 200 mmHg.
•3. Patient who satisfied either (a) or (b).
•a. Patient who was on stable dose of FDC of Losartan 50mg and hydrochlorothiazide
•12.5mg or FDC of Losartan 50mg and amlodipine 5mg at least 6 weeks as per
•historical record.
•b. New Patient or who was on stable dose of Losartan 50mg or Amlodipine 5mg or
•Hydrochlorothiazide 12.5mg.
•4. Patient willingly gave informed consent.

•1. Pregnant, lactating woman or woman of childbearing age who was not using an acceptable
•method of birth control.
•2. Patient who was taking >=3 antihypertensive medications at the time of screening.
•3. Patient who had history of treatment resistant hypertension, defined as BP >=140/90 mm Hg
•while taking triple-combination therapy (one of which was a diuretic) at the optimal dose of
•4. Patient who had evidence of a secondary hypertension.
•5. Patient who had significant heart disease (e.g., recent stroke/transient ischemic attack, heart
•failure, coronary artery bypass graft surgery, coronary intervention, angina pectoris,
•myocardial infarction, heart block, atrial fibrillation/flutter, or valve disease).
•6. Patient who had type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus.
•7. Patient who had significant pancreatic, renal or hepatic disease.
•8. Patient who was hypersensitive to Losartan, Amlodipine or Hydrochlorothiazide.
•9. Patient with anuria or hypersensitivity to other sulfonamide-derived drugs.
•10. Patient with hepatic impairment who require titration with losartan.
•11. Patient with or without a history of allergy or bronchial asthma.
•12. Patient taking Lithium.
•13. Patient using potassium supplements or salt substitutes containing potassium.
•14. Patient who required or takes concomitant medications known to significantly affect BP.

发起方

Sun Pharma Laboratories Limited SP