Trial | NCT03978884  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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.
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 Started
Jun 01
2019
Anticipated
Primary Completion
May 31
2020
Anticipated
Study Completion
Dec 31
2020
Anticipated
Last Update
Sep 03
2020

Drug Losartan 50Mg Tab

Take 1 tab daily

Drug Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET [hydrochlorothiazide (esidrix), losartan (cozaar)]

Take 1 tab daily

Drug Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET [losartan (cozaar), hydrochlorothiazide (esidrix)]

Take 1 tab daily

Drug Amlodipine 5mg

Take 1 tablet daily

Mild Hypertensive Experimental

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

Mild Hypertensive with Diabetes Experimental

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

Severe Hypertension Experimental

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

Severe Hypertension with Diabetes Experimental

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

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.
No Results Posted