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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03978884
• Other study ID #: ECP231516
• Status: Withdrawn
• Phase: Phase 4
• Start date: June 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2019
• Source: The University of The West Indies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hypertension

Intervention

Drug:
• Losartan 50Mg Tab
Take 1 tab daily
• Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET
Take 1 tab daily
• Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET
Take 1 tab daily
• Amlodipine 5mg
Take 1 tablet daily

Locations

Country	Name	City	State
Jamaica	Tropical Metabolism Research Unit	Kingston	Other

Sponsors (2)

Lead Sponsor	Collaborator
The University of The West Indies	Caribbean College of Family Physicians

Country where clinical trial is conducted

Jamaica, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects achieving Target Blood Pressure		12 weeks