NCT03978884

Phase 4 Study of the Efficacy of Losartan Based Therapy in Hypertensives With and Without Diabetes

An Open Label, Single Arm Prospective Study to Evaluate Efficacy and Safety of Losartan Based Therapy Reslio® (Losartan) and Resilo-h® (Losartan+Hydrochlorthiazide) in Diabetic and Uncontrolled Hypertensive Patients

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The University of The West Indies · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes Mellitus
• Hypertension

Interventions

Type	Name	Description
DRUG	Losartan 50Mg Tab	Take 1 tab daily
DRUG	Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET	Take 1 tab daily
DRUG	Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET	Take 1 tab daily
DRUG	Amlodipine 5mg	Take 1 tablet daily

Timeline

• Start date: 2019-06-01
• Primary completion: 2020-05-31
• Completion: 2020-12-31
• First posted: 2019-06-07
• Last updated: 2020-09-03

Locations

1 site across 1 country: Jamaica