Diabetes MellitusPhase 4NCT03978884
Phase 4 Study of the Efficacy of Losartan Based Therapy in Hypertensives With and Without Diabetes
A Phase 4 study testing Losartan 50Mg Tab, Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET and Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET in people with Diabetes Mellitus and Hypertension, run by The University of The West Indies at 1 site in Jamaica.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Hypertension
- What is being tested?
- Losartan 50Mg Tab, Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET and Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteJamaica
- Study dates
- 1 Jun 2019to 31 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Hypertension
- Being tested
- Losartan 50Mg Tab, Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET, Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET, Amlodipine 5mg
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan 50Mg TabDrug
Take 1 tab daily
Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLETDrug
Take 1 tab daily
Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLETDrug
Take 1 tab daily
Amlodipine 5mgDrug
Take 1 tablet daily
| Study group | Role | What they receive |
|---|---|---|
| Mild Hypertensive | Experimental | Mild Hypertensive with systolic BP >=140 mmHg but less than 160 mmHg at baseline with diastolic >=90 but <100 mmHg Receives: Drug: Losartan 50Mg Tab; Drug: 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. Receives: Drug: Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET; Drug: 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 Receives: Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET; Drug: Amlodipine 5mg |
| Severe Hypertension with Diabetes | Experimental | Severe Hypertensive with systolic BP >=160 mmHg at baseline or with diastolic >=100 mmHg with diabetes Receives: Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET; Drug: Amlodipine 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects achieving Target Blood Pressure
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start1 Jun 2019 (estimated)
- Primary completion31 May 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: Unable to effective arrange trial logistics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Collaborators
- Caribbean College of Family Physicians
- Responsible party
- Sponsor
- Investigators
- Marvin Reid, Principal investigator, University of the West Indies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978884
- Sponsor's protocol ID
- ECP231516
- Status last verified
- May 2019
- First submitted
- 5 Jun 2019
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03978884
- Acronym / sponsor ID
- ECP231516
- Conditions
- Diabetes Mellitus, Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to effective arrange trial logistics
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Collaborators
- Caribbean College of Family Physicians
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild Hypertensive | Experimental | Drug: Losartan 50Mg Tab, Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLETMild Hypertensive with systolic BP >=140 mmHg but less than 160 mmHg at baseline with diastolic >=90 but <100 mmHg |
| Mild Hypertensive with Diabetes | Experimental | Drug: Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET, Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLETMild Hypertensive with systolic BP >=140 mmHg but less than 160 mmHg at baseline with diastolic >=90 but <100 mmHg and diabetes. |
| Severe Hypertension | Experimental | Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET, Drug: Amlodipine 5mgSevere Hypertensive with systolic BP >=160 mmHg at baseline or with diastolic >=100 mmHg |
| Severe Hypertension with Diabetes | Experimental | Drug: Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET, Drug: Amlodipine 5mgSevere Hypertensive with systolic BP >=160 mmHg at baseline or with diastolic >=100 mmHg with diabetes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Losartan 50Mg TabTake 1 tab daily | Drug | Mild Hypertensive |
| Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLETTake 1 tab daily | Drug | Mild Hypertensive with Diabetes |
| Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLETTake 1 tab daily | Drug | Mild Hypertensive, Mild Hypertensive with Diabetes, Severe Hypertension, Severe Hypertension with Diabetes |
| Amlodipine 5mgTake 1 tablet daily | Drug | Severe Hypertension, Severe Hypertension with Diabetes |
Primary outcome
Proportion of Subjects achieving Target Blood Pressure
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marvin Reid principal investigator
University of the West Indies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Losartan 50Mg Tab, Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET and Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET in people with Diabetes Mellitus and Hypertension, run by The University of The West Indies at 1 site in Jamaica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jamaica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects achieving Target Blood Pressure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.