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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hypertension; Diabetes Mellitus
• Intervention / Treatment: Drug: Losartan 50Mg Tab; Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET; Drug: Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET; Drug: Amlodipine 5mg

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Jamaica
  • Other
    • Kingston, Other, Jamaica, 007
      • Tropical Metabolism Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mild Hypertensive; Mild Hypertensive with systolic BP >=140 mmHg but less than 160 mmHg at baseline with diastolic >=90 but <100 mmHg	Drug: Losartan 50Mg Tab; Take 1 tab daily; Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET; Take 1 tab daily
Experimental: Mild Hypertensive with Diabetes; 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 100 Mg-25 Mg ORAL TABLET; Take 1 tab daily; Drug: Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET; Take 1 tab daily
Experimental: Severe Hypertension; Severe Hypertensive with systolic BP >=160 mmHg at baseline or with diastolic >=100 mmHg	Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET; Take 1 tab daily; Drug: Amlodipine 5mg; Take 1 tablet daily
Experimental: Severe Hypertension with Diabetes; 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; Take 1 tab daily; Drug: Amlodipine 5mg; Take 1 tablet daily

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of The West Indies
• Collaborators: Caribbean College of Family Physicians
• Investigators: Principal Investigator: Marvin Reid, University of the West Indies

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): May 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (Actual): June 7, 2019

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Amlodipine; Losartan; Hydrochlorothiazide
• Other Study ID Numbers: ECP231516

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No