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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
Patients who have uncontrolled hypertension and who require triple therapy will be randomized to receive:
We expect fixed triple combination to be more effective because the drugs used work synergistically together and the compliance will be higher
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LosanetAMplus | Active Comparator | Patients taking the fixed triple combination |
|
| standard of care | Other | Patients taking 2 or 3 free combinations containing 3 drugs for hypertension as decided by the treating physician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Losartan and amlodipine and hydrochlorothiazide | Drug | this is a fixed combination containing the 3 drugs |
|
| Measure | Description | Time Frame |
|---|---|---|
| average 24 hour blood pressure measured by ambulatory recording | Measured by ambulatory blood pressure recording over 24 hours | measured after 2 months of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| central aortic blood pressure | measured after 2 months of therapy | |
| pulse wave velocity | measured after 2 months of therapy |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rabih R Azar, MD, MPH | Contact | +9611615300 | 9418 | razar@usj.edu.lb |
| Name | Affiliation | Role |
|---|---|---|
| Rabih R Azar, MD, MPH | Hotel Dieu de France Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotel Dieu de France Hospital | Recruiting | Beirut | Beirut | Lebanon |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019808 | Losartan |
| D017311 | Amlodipine |
| D006852 | Hydrochlorothiazide |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Standard of care | Drug | any free triple combination therapy for hypertension given as 2 or 3 pills |
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |