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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Hypertension

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild Hypertensive<br>Mild Hypertensive with systolic BP >=140 mmHg but less than 160 mmHg at baseline with diastolic >=90 but <100 mmHg | Drug: Losartan 50Mg Tab<br>* Take 1 tab daily<br>Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET<br>* Take 1 tab daily<br>|
| Experimental: Mild Hypertensive with Diabetes<br>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<br>* Take 1 tab daily<br>Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET<br>* Take 1 tab daily<br>|
| Experimental: Severe Hypertension<br>Severe Hypertensive with systolic BP >=160 mmHg at baseline or with diastolic >=100 mmHg | Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET<br>* Take 1 tab daily<br>Drug: Amlodipine 5mg<br>* Take 1 tablet daily<br>|
| Experimental: Severe Hypertension with Diabetes<br>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<br>* Take 1 tab daily<br>Drug: Amlodipine 5mg<br>* Take 1 tablet daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects achieving Target Blood Pressure |  | 12 weeks |