This study will evaluate the effectiveness of the nifedipine (Adalat) gastrointestinal therapeutic system (GITS) on lowering blood pressure in adults with hypertension. The main outcomes measured will be blood pressure levels at follow-up and the change in blood pressure from the beginning to the end of treatment.
The details
Nifedipine is a drug used to treat high blood pressure (hypertension). It is a calcium channel blocker that works by relaxing blood vessels so blood flows more easily. The nifedipine GITS system provides stable levels of nifedipine over 24 hours. The tablet has two layers and a laser-drilled hole on the outside. This helps release the medicine into the stomach at a constant rate over a long time.
This study will evaluate the effectiveness of the nifedipine GITS system on lowering blood pressure in adults with hypertension. The main outcomes will be blood pressure at follow-up and the change in blood pressure from the beginning to the end of treatment.
Who are they looking for?
This study is looking for 700 patients with hypertension. Patients should not have taken any medications for lowering blood pressure within 1 month of the study. Patients should have a systolic blood pressure between 140 - 180 mmHg and a diastolic blood pressure between 90 and 110 mmHg.
Patients who have blood pressure that is 180 mmHg (systolic) or 110 mmHg (diastolic) or higher cannot participate. Patients with heart failure, stroke, or heart murmurs cannot participate. Patients with a history of uncontrolled chest pain or a heart attack cannot participate. Women who are pregnant or breastfeeding cannot participate. Patients who are allergic to nifedipine, those with abnormal liver and kidney function tests, and those participating in other clinical trials will be excluded.
How will it work
All patients will receive nifedipine GTS. Patients will be followed up at 2 weeks, 4 weeks, and 8 weeks. Patients will have their blood pressure measured at each follow-up visit. At the end of the study, all patients will have 24-hour blood pressure monitoring.
The main outcomes will be blood pressure at each follow-up visit and the change in blood pressure from the beginning to the end of treatment.
