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

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ClinicalTrials.gov Identifier: NCT03978884
Recruitment Status : Not yet recruiting
First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Collaborator:
Caribbean College of Family Physicians
Information provided by (Responsible Party):
The University of The West Indies

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Hypertension Drug: Losartan 50Mg Tab Drug: Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET Drug: Amlodipine 5mg Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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 50 Mg-12.5 Mg ORAL TABLET
Take 1 tab daily

Drug: Losartan/Hydrochlorothiazide 100 Mg-25 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




Primary Outcome Measures :
  1. Proportion of Subjects achieving Target Blood Pressure [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   self-representation of gender identity
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03978884


Contacts
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Contact: Marvin Reid, MD 8769271884 marvin.reid@uwimona.edu.jm
Contact: Cassandra Wint-Rose cassandra.wint@uwimona.edu.jm

Locations
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Jamaica
Tropical Metabolism Research Unit Not yet recruiting
Kingston, Other, Jamaica, 007
Contact: Marvin Reid, MB BS    8769271884    marvin.reid@uwimona.edu.jm   
Sponsors and Collaborators
The University of The West Indies
Caribbean College of Family Physicians
Investigators
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Principal Investigator: Marvin Reid University of the West Indies

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Responsible Party: The University of The West Indies
ClinicalTrials.gov Identifier: NCT03978884     History of Changes
Other Study ID Numbers: ECP231516
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Losartan
Amlodipine
Hydrochlorothiazide
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors