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

Phase 4

Withdrawn

• Conditions: Diabetes Mellitus; Hypertension
• Interventions: Drug: Losartan 50Mg Tab; Drug: Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET; Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET; Drug: Amlodipine 5mg

• Registration Number: NCT03978884
• Lead Sponsor: The University of The West Indies

Brief 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.

Study Timeline

• Status Verified: 2019-05
• Study Start: 2019-06-01
• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-07
• Primary Completion: 2020-05-31
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-03
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Willing to sign Informed Consent Form.
• Patients of either sex above 18 years of age.
• Patients not previously diagnosed with hypertension and with sitting blood pressure > 140/90 mmHg on two readings 15 minutes apart.
• Newly diagnosed hypertensive patients.
• Hypertensive patients on other antihypertensive therapies but not at goal
• Diabetes defined as patient on insulin therapy or oral diabetic therapy or fasting blood glucose on screening > 7 mmol/L

Exclusion Criteria

• Patients with history of allergic reaction to any angiotensin II antagonist or a thiazide diuretic
• Patients with history suggestive secondary hypertension
• Patients who have taken Resilo or Resilo-H or other losartan based treatment in past three months of study inclusion.
• Patients with chronic renal failure or who on screening has serum creatinine >150 µmol/L
• Patients who is participating concurrently in another clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild Hypertensive with Diabetes	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.
Mild Hypertensive	Losartan 50Mg Tab	Mild Hypertensive with systolic BP \>=140 mmHg but less than 160 mmHg at baseline with diastolic \>=90 but \<100 mmHg
Mild Hypertensive	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
Mild Hypertensive with Diabetes	Losartan/Hydrochlorothiazide 50 Mg-12.5 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.
Severe Hypertension	Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET	Severe Hypertensive with systolic BP \>=160 mmHg at baseline or with diastolic \>=100 mmHg
Severe Hypertension with Diabetes	Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET	Severe Hypertensive with systolic BP \>=160 mmHg at baseline or with diastolic \>=100 mmHg with diabetes
Severe Hypertension	Amlodipine 5mg	Severe Hypertensive with systolic BP \>=160 mmHg at baseline or with diastolic \>=100 mmHg
Severe Hypertension with Diabetes	Amlodipine 5mg	Severe Hypertensive with systolic BP \>=160 mmHg at baseline or with diastolic \>=100 mmHg with diabetes

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects achieving Target Blood Pressure	12 weeks

Trial Locations

Locations (1)

Tropical Metabolism Research Unit; 🇯🇲 Kingston, Other, Jamaica