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出境医 / 临床实验 / Phase 4 Study of the Efficacy of Losartan Based Therapy in Hypertensives With and Without Diabetes

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

Study Description
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 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
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  1. Proportion of Subjects achieving Target Blood Pressure [ Time Frame: 12 weeks ]

Eligibility Criteria
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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.
Contacts and Locations

Locations
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Jamaica
Tropical Metabolism Research Unit
Kingston, Other, Jamaica, 007
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
Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date September 3, 2020
Estimated Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019) 		Proportion of Subjects achieving Target Blood Pressure [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 4 Study of the Efficacy of Losartan Based Therapy in Hypertensives With and Without Diabetes
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus
  • Hypertension
Intervention  ICMJE
  • Drug: Losartan 50Mg Tab
    Take 1 tab daily
  • 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
  • Drug: Amlodipine 5mg
    Take 1 tablet daily
Study Arms  ICMJE
  • Experimental: Mild Hypertensive
    Mild Hypertensive with systolic BP >=140 mmHg but less than 160 mmHg at baseline with diastolic >=90 but <100 mmHg
    Interventions:
    • Drug: Losartan 50Mg Tab
    • Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET
  • 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.
    Interventions:
    • Drug: Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET
    • Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET
  • Experimental: Severe Hypertension
    Severe Hypertensive with systolic BP >=160 mmHg at baseline or with diastolic >=100 mmHg
    Interventions:
    • Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET
    • Drug: Amlodipine 5mg
  • Experimental: Severe Hypertension with Diabetes
    Severe Hypertensive with systolic BP >=160 mmHg at baseline or with diastolic >=100 mmHg with diabetes
    Interventions:
    • Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET
    • Drug: Amlodipine 5mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 1, 2020) 		0
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2019) 		200
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: self-representation of gender identity
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Jamaica
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03978884
Other Study ID Numbers  ICMJE ECP231516
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The University of The West Indies
Study Sponsor  ICMJE The University of The West Indies
Collaborators  ICMJE Caribbean College of Family Physicians
Investigators  ICMJE
Principal Investigator: Marvin Reid University of the West Indies
PRS Account The University of The West Indies
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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