Evaluation of the Clinical Efficacy and Safety of Amlodipine 5mg/ Bisoprolol Fumarate 5mg /Perindopril Arginine 5mg Fixed-dose Combination in Capsule and Free Monotherapy at the Same Dose in Patients With Uncontrolled Essential Hypertension.
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Study description
This study was done to test the study drug called amlodipine/bisoprolol/perindopril (a single capsule) in patients who have high blood pressure despite undergoing treatment for this condition.
High blood pressure is a common condition that may cause health problems, such as heart diseases. Doctors make the diagnosis by measuring blood pressure.
When blood pressure is measured, two values are recorded. The higher value is called systolic blood pressure (SBP). The lower value is called diastolic blood pressure (DBP). Blood pressure is written as systolic pressure/diastolic pressure. For example, 120/80 mmHg (millimeters of mercury).
Some patients can have their blood pressure well controlled with a single drug treatment. Others require two or more drugs to get the desired effect. When this happens, patients may forget or dislike taking several pills, and so there is a chance that blood pressure remains uncontrolled. For these reasons, it can be desirable to combine several drugs into a single pill. This is the reason why researchers have developed the study drug.
The study drug is a single capsule containing three drugs: amlodipine, bisoprolol and perindopril. All these drugs are already approved to treat high blood pressure and other heart diseases. These drugs are available as a separate tablet. This study is called a phase 3 study. The aims of the study were:
- To test the effectiveness of the study drug and the 3 separate tablets in treating high blood pressure.
- To evaluate the safety of the study drug and the 3 separate tablets.
- Amlodipine 5mg + bisoprolol fumarate 5mg + perindopril arginine 5mg
- Norvasc 5mg tablet
- Concor 5mg tablet
- Coversyl 5mg tablet
- CL3-05166-003
Eligibility Criteria
Eligible age for the study
Sexes
Male/FemaleAccepts Healthy Volunteers
NoTo take part, participants had to:
- Be at least 18 years old.
- Have been diagnosed with uncontrolled high blood pressure despite undergoing treatment. Uncontrolled means that:
- The systolic blood pressure was between 140 and 160 mmHg.
- The diastolic blood pressure was between 90 and 100 mmHg.
Participants could not take part in the study if they:
- Had a history of kidney, cerebrovascular or heart disease. Cerebrovascular diseases are conditions affecting the blood vessels in the brain.
- Had a known or suspected postural hypotension, which is a sudden drop in blood pressure due to changes in posture such as when a person stands up from a sitting or lying position.
How is the study designed?
Participants received one single capsule of a fixed dose combination of amlodipine 5mg/bisoprolol 5 mg/perindopril 5 mg (study drug).
Participants received 3 separate tablets, called a free combination (one tablet of amlodipine 5 mg + one tablet of bisoprolol 5 mg + one tablet of perindopril 5 mg taken at the same time).