This study is evaluating the safety and effectiveness of losartan (Cozaar) plus hydrochlorothiazide (Microzide) in a single tablet for treating high blood pressure. The main outcomes will be blood pressure control rate after treatment and the number of patients who experience side effects.
The details
High blood pressure (hypertension) increases the workload of the heart and arteries. Over a long time, this leads to the heart and arteries not working properly. This can damage the blood vessels of the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. Many patients with hypertension need more than one type of blood pressure-lowering drug to control blood pressure. Combining two drugs in a single tablet makes it easier for patients to follow the treatment.
Losartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance that causes blood vessels to tighten, therefore improving blood flow. Hydrochlorothiazide is a diuretic drug (water pill). It helps the body produce more urine, therefore getting rid of excess water and salt.
This study is evaluating the safety and effectiveness of losartan plus hydrochlorothiazide in a single tablet for managing high blood pressure. The main outcomes will be blood pressure after treatment and the number of patients who experience side effects.
Who are they looking for?
This study is looking for 300 patients. Patients should not have had blood pressure medications before. Patients who are already on blood pressure-lowering medications can participate, but should not have stopped taking them for more than 2 weeks. Patients should have a systolic blood pressure (pressure during a heartbeat) between 140 and 179 mmHg. Patients should have a diastolic blood pressure (pressure in between heartbeats) between 90 and 109 mmHg.
Patients with high blood pressure caused by another medical condition, such as kidney disease or endocrine conditions, cannot participate. Patients with a history of heart disease, heart attack, heart failure, stroke, gout, or dementia cannot participate. Patients with liver failure or abnormal kidney or electrolyte tests cannot participate. Patients who are taking other medications that might affect blood pressure cannot participate.
How will it work
Patients will be divided into two groups. The first group will receive 100 mg losartan plus 25 mg hydrochlorothiazide in a single tablet. The second group will receive 5 mg amlodipine besylate (Norvasc) and 25 mg hydrochlorothiazide, each in a separate tablet. Patients will be followed for 8 weeks.
The main outcomes will be blood pressure after treatment and the number of patients who experience side effects. Blood pressure will also be monitored over 24 hours in each group.
