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

NCT ID: NCT03978884

Last Updated: 2020-09-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2020-12-31

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.

Conditions

Diabetes Mellitus; Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mild Hypertensive

Mild Hypertensive with systolic BP \>=140 mmHg but less than 160 mmHg at baseline with diastolic \>=90 but \<100 mmHg

Group Type: EXPERIMENTAL

Losartan 50Mg Tab

Intervention Type: DRUG

Take 1 tab daily

Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET

Intervention Type: DRUG

Take 1 tab daily

Mild Hypertensive with Diabetes

Mild Hypertensive with systolic BP \>=140 mmHg but less than 160 mmHg at baseline with diastolic \>=90 but \<100 mmHg and diabetes.

Group Type: EXPERIMENTAL

Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET

Intervention Type: DRUG

Take 1 tab daily

Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET

Intervention Type: DRUG

Take 1 tab daily

Severe Hypertension

Severe Hypertensive with systolic BP \>=160 mmHg at baseline or with diastolic \>=100 mmHg

Group Type: EXPERIMENTAL

Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET

Intervention Type: DRUG

Take 1 tab daily

Amlodipine 5mg

Intervention Type: DRUG

Take 1 tablet daily

Severe Hypertension with Diabetes

Severe Hypertensive with systolic BP \>=160 mmHg at baseline or with diastolic \>=100 mmHg with diabetes

Group Type: EXPERIMENTAL

Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET

Intervention Type: DRUG

Take 1 tab daily

Amlodipine 5mg

Intervention Type: DRUG

Take 1 tablet daily

Interventions

Losartan 50Mg Tab

Take 1 tab daily

Intervention Type: DRUG

Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET

Take 1 tab daily

Intervention Type: DRUG

Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET

Take 1 tab daily

Intervention Type: DRUG

Amlodipine 5mg

Take 1 tablet daily

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Caribbean College of Family Physicians

UNKNOWN

Sponsor Role: collaborator

The University of The West Indies

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marvin Reid

Role: PRINCIPAL_INVESTIGATOR

University of the West Indies

Locations

Tropical Metabolism Research Unit

Kingston, Other, Jamaica

Countries

Jamaica

Other Identifiers

ECP231516

Identifier Type: -

Identifier Source: org_study_id