Diabetes Mellitus, Hypertension
Conditions
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.
Interventions
Take 1 tab daily
DRUGLosartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET
Take 1 tab daily
DRUGLosartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET
Take 1 tab daily
DRUGAmlodipine 5mg
Take 1 tablet daily
Sponsors
Caribbean College of Family Physicians
The University of The West Indies
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Subjects achieving Target Blood Pressure | 12 weeks |
Countries
Jamaica
Outcome results
None listed