A Phase 4 interventional study of Losartan 50Mg Tab and Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET in Diabetes Mellitus and Hypertension, sponsored by The University of The West Indies. Withdrawn at 1 site in Jamaica. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-09-03.
Sponsored by The University of The West Indies · Phase 4, Interventional, and Treatment
To study antihypertensive efficacy of 12 weeks of Losartan based therapy Resilo (Losartan) and Resilo-H (Losartan+ Hydrochlorothiazide) in uncontrolled hypertensive and diabetic hypertensive patients.
200 hundred Subjects will be treated with a dose escalation regimen to achieve a target blood pressure. Subjects with mild hypertension at baseline will be started with losartan 50 mgs and those with severe hypertension will be started with losartan H 100/25. After 6 weeks they will titrated if goal blood pressure not achieved. For Mild hypertensive group this will be with losartan H 100/25 and for severe hypertensive group this will by addition of amlodipine 5 mg to regime. Subjects with mild hypertension and diabetes at baseline will be started with losartan H 50/12.5 mg and those with severe hypertension with diabetes will be started with losartan H 100/25. After 6 weeks they will be titrated if goal blood pressure not achieved. For Mild hypertensive-diabetic group this will be with Resilo H 100/25 and for severe hypertensive group this will by addition of amlodipine 5 mg to regime.
Target Blood Pressure is systolic \< 140 mmhg and diastolic \< 90 mmHg if age \< 60 years and systolic \< 150 mmHg and diastolic \< 90 mmHg if age >60 years.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
Browse Diabetes Mellitus studies →The University of The West Indies is the lead sponsor of 64 studies on the registry; 15 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mild Hypertensive with systolic BP \>=140 mmHg but less than 160 mmHg at baseline with diastolic \>=90 but \<100 mmHg
Drug: Losartan 50Mg Tab · Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET
Mild Hypertensive with systolic BP \>=140 mmHg but less than 160 mmHg at baseline with diastolic \>=90 but \<100 mmHg and diabetes.
Drug: Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET · Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET
Severe Hypertensive with systolic BP \>=160 mmHg at baseline or with diastolic \>=100 mmHg
Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET · Drug: Amlodipine 5mg
Severe Hypertensive with systolic BP \>=160 mmHg at baseline or with diastolic \>=100 mmHg with diabetes
Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET · Drug: Amlodipine 5mg
Take 1 tab daily
Take 1 tab daily
Take 1 tab daily
Take 1 tablet daily
Proportion of Subjects achieving Target Blood Pressure
Time frame: 12 weeks
Plan to share: No
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This study is withdrawn, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Losartan
The University of The West Indies