NCT03978884

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 3, 2020

Status Verified

May 1, 2019

Enrollment Period

1 year

First QC Date

June 5, 2019

Last Update Submit

September 1, 2020

Conditions

Diabetes MellitusHypertension

Outcome Measures

Primary Outcomes (1)

  • Proportion of Subjects achieving Target Blood Pressure

    12 weeks

Study Arms (4)

Mild Hypertensive

EXPERIMENTAL

Mild Hypertensive with systolic BP \>=140 mmHg but less than 160 mmHg at baseline with diastolic \>=90 but \<100 mmHg

Drug: Losartan 50Mg TabDrug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET

Mild Hypertensive with Diabetes

EXPERIMENTAL

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 TABLETDrug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET

Severe Hypertension

EXPERIMENTAL

Severe Hypertensive with systolic BP \>=160 mmHg at baseline or with diastolic \>=100 mmHg

Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLETDrug: Amlodipine 5mg

Severe Hypertension with Diabetes

EXPERIMENTAL

Severe Hypertensive with systolic BP \>=160 mmHg at baseline or with diastolic \>=100 mmHg with diabetes

Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLETDrug: Amlodipine 5mg

Interventions

Losartan 50Mg TabDRUG

Take 1 tab daily

Mild Hypertensive
Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLETDRUG

Take 1 tab daily

Mild Hypertensive with Diabetes
Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLETDRUG

Take 1 tab daily

Mild HypertensiveMild Hypertensive with DiabetesSevere HypertensionSevere Hypertension with Diabetes
Amlodipine 5mgDRUG

Take 1 tablet daily

Severe HypertensionSevere Hypertension with Diabetes

Eligibility Criteria

Age18 Years - 80 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with history of allergic reaction to any angiotensin II antagonist or a thiazide diuretic
  • Patients with history suggestive secondary hypertension
  • Patients with chronic renal failure or who on screening has serum creatinine \>150 µmol/L
  • Patients who is participating concurrently in another clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tropical Metabolism Research Unit

Kingston, Other, 007, Jamaica

Location

MeSH Terms

Conditions

Diabetes MellitusHypertension

Interventions

LosartanHydrochlorothiazideAmlodipine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDihydropyridinesPyridines

Study Officials

  • Marvin Reid

    University of the West Indies

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 7, 2019

Study Start

June 1, 2019

Primary Completion

May 31, 2020

Study Completion

December 31, 2020

Last Updated

September 3, 2020

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

JA(1)