HypertensionPhase 4NCT03578042
Fixed-Free HTN Trial
A Phase 4 study testing Losartan and amlodipine and hydrochlorothiazide in people with Hypertension, run by Hotel Dieu de France Hospital at 1 site in Lebanon.
Trial summary
Evaluation of the effect of FIXED triple anti-hypertensive therapy with losartan-amlodipin-HCTZ vs any free triple combination therapy chosen by the treating physician for patients with uncontrolled hypertension Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Losartan and amlodipine and hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Apr 2017to 30 Dec 2019
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients already on free triple anti-HTN therapy whether controlled or not Or patients on double anti-HTN therapy who are uncontrolled* Or patients on monotherapy and who have a BP > 160/100 mm Hg
- BP is defined as UNCONTROLLED if > 135/85 at home or > 140/90 in clinic on at least 2 occasions
Who cannot join
- Contra-indication for the use of ARB or ACEI, CCB or hydrochlorothiazide History of angina pectoris or myocardial infarction < 3 months old Permanent atrial fibrillation Ejection fraction < 40% Patients with hypertension but who are not on any medication Patients with hypertension and who are treated with > 3 drugs
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Hotel Dieu de France Hospital
Beirut, Beirut
Rabih R Azar, MD, MPH, +9611615300 ext. 9408, razar@usj.edu.lb
About this study
Official title: Effect of Fixed Triple Combination With Losartan-Amlodipin-HCTZ vs. Free Triple Combination on Blood Pressure Control
Evaluation of the effect of FIXED triple anti-hypertensive therapy with losartan-amlodipin-HCTZ vs any free triple combination therapy chosen by the treating physician for patients with uncontrolled hypertension
Read the detailed description
Patients who have uncontrolled hypertension and who require triple therapy will be randomized to receive:
- Fixed combination containing 3 anti-hypertensive drugs: losartan 100 mg + amlodipin 5 mg + hydrocholorothiazide 12.5 mg one tab/day
- Or any other therapy decided by the treating physician containing three anti-hypertensive agents but supplied as "free" therapy, meaning supplied as 2 or 3 separate tablets Patients will have a baseline ambulatory blood pressure recording. The same recording will be repeated at 2 months of therapy.
We expect fixed triple combination to be more effective because the drugs used work synergistically together and the compliance will be higher
- Conditions
- Hypertension
- Being tested
- Losartan and amlodipine and hydrochlorothiazide, Standard of care
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan and amlodipine and hydrochlorothiazideDrug
this is a fixed combination containing the 3 drugs
Standard of careDrug
any free triple combination therapy for hypertension given as 2 or 3 pills
| Study group | Role | What they receive |
|---|---|---|
| LosanetAMplus | Active comparator | Patients taking the fixed triple combination Receives: Drug: Losartan and amlodipine and hydrochlorothiazide |
| standard of care | Other | Patients taking 2 or 3 free combinations containing 3 drugs for hypertension as decided by the treating physician Receives: Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
average 24 hour blood pressure measured by ambulatory recording
Measured by ambulatory blood pressure recording over 24 hours
Measured: measured after 2 months of therapy
Secondary outcomes (2)
central aortic blood pressure
Measured: measured after 2 months of therapy
pulse wave velocity
Measured: measured after 2 months of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start1 Apr 2017
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hotel Dieu de France Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabih Azar, Hotel Dieu de France Hospital
- Investigators
- Rabih R Azar, MD, MPH, Principal investigator, Hotel Dieu de France Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578042
- Sponsor's protocol ID
- Losanet AM Plus trial
- Status last verified
- Jun 2018
- First submitted
- 24 Jun 2018
- Last updated
- 5 Jul 2018
- 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 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fixed Triple Combination With Losartan-Amlodipin-HCTZ vs. Free Triple Combination on Blood Pressure Control
- ClinicalTrials.gov ID
- NCT03578042
- Acronym / sponsor ID
- Losanet AM Plus trial
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hotel Dieu de France HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 5 Jul 2018 (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.
Evaluation of the effect of FIXED triple anti-hypertensive therapy with losartan-amlodipin-HCTZ vs any free triple combination therapy chosen by the treating physician for patients with uncontrolled hypertension
Detailed description
Patients who have uncontrolled hypertension and who require triple therapy will be randomized to receive:
- Fixed combination containing 3 anti-hypertensive drugs: losartan 100 mg + amlodipin 5 mg + hydrocholorothiazide 12.5 mg one tab/day
- Or any other therapy decided by the treating physician containing three anti-hypertensive agents but supplied as "free" therapy, meaning supplied as 2 or 3 separate tablets Patients will have a baseline ambulatory blood pressure recording. The same recording will be repeated at 2 months of therapy.
We expect fixed triple combination to be more effective because the drugs used work synergistically together and the compliance will be higher
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LosanetAMplus | Active comparator | Drug: Losartan and amlodipine and hydrochlorothiazidePatients taking the fixed triple combination |
| standard of care | Other | Drug: Standard of carePatients taking 2 or 3 free combinations containing 3 drugs for hypertension as decided by the treating physician |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients already on free triple anti-HTN therapy whether controlled or not Or patients on double anti-HTN therapy who are uncontrolled* Or patients on monotherapy and who have a BP > 160/100 mm Hg
Key exclusion criteria (1 listed)
- Contra-indication for the use of ARB or ACEI, CCB or hydrochlorothiazide History of angina pectoris or myocardial infarction < 3 months old Permanent atrial fibrillation Ejection fraction < 40% Patients with hypertension but who are not on any medication Patients with hypertension and who are treated with > 3 drugs
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 and amlodipine and hydrochlorothiazidethis is a fixed combination containing the 3 drugs | Drug | LosanetAMplus |
| Standard of careany free triple combination therapy for hypertension given as 2 or 3 pills | Drug | standard of care |
Primary outcome
average 24 hour blood pressure measured by ambulatory recording
Time frame: measured after 2 months of therapy
Measured by ambulatory blood pressure recording over 24 hours
2 secondary outcomes
central aortic blood pressure
Time frame: measured after 2 months of therapy
pulse wave velocity
Time frame: measured after 2 months of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- 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.
Rabih R Azar, MD, MPH principal investigator
Hotel Dieu de France Hospital
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 and amlodipine and hydrochlorothiazide in people with Hypertension, run by Hotel Dieu de France Hospital at 1 site in Lebanon.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Jul 2018. 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 Lebanon. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rabih R Azar, MD, MPH (+9611615300 ext. 9418, razar@usj.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
average 24 hour blood pressure measured by ambulatory recording (time frame: measured after 2 months of therapy). 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 5 Jul 2018.