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

The University of The West Indies

Status and phase: Withdrawn; Phase 4

Conditions: Hypertension; Diabetes Mellitus

Treatments: Drug: Amlodipine 5mg; Drug: Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET; Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET; Drug: Losartan 50Mg Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT03978884

ECP231516

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

Mild Hypertensive

Experimental group

Description:

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

Treatment:

Drug: Losartan 50Mg Tab

Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET

Mild Hypertensive with Diabetes

Experimental group

Description:

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

Treatment:

Drug: Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET

Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET

Severe Hypertension

Experimental group

Description:

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

Treatment:

Drug: Amlodipine 5mg

Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET

Severe Hypertension with Diabetes

Experimental group

Description:

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

Treatment:

Drug: Amlodipine 5mg

Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET