Clinical trial NCT03978884: Phase 4 Study of the Efficacy of Losartan Based Therapy in Hypertensives With and Without Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Diabetes Mellitus
Hypertension
Lead sponsor: The University of The West Indies
Sponsor class: OTHER
Collaborators: name: Caribbean College of Family Physicians
First posted: 2019-06-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Proportion of Subjects achieving Target Blood Pressure
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Jamaica
facility: Tropical Metabolism Research Unit
state: Other
Study officials:
affiliation: University of the West Indies
name: Marvin Reid
role: PRINCIPAL_INVESTIGATOR
References: