Efficacy and Safety of Perindopril 5 mg / Indapamide 1.25 mg / Amlodipine 5 mg Fixed Combination in Hypertension
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Study description
The study was done to test the combination of 3 drugs (perindopril, indapamide and amlodipine) that lower blood pressure in a single pill (called a fixed combination) in patients with high blood pressure.
The study was designed for the registration of the combination in China.
High blood pressure is a common condition that may cause health problems, such as heart disease. 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) and is produced when the heart contracts (this is your pulse). The lower value is called diastolic blood pressure (DBP) and is the “background” pressure of the blood. Blood pressure is written as SBP/DBP. For example, 120/80 mmHg (millimetres of mercury).
Some patients 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 to take one of them 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 main objective of the study was to test whether the combination of perindopril, indapamide and amlodipine in a single pill (fixed combination) works as well or almost as well as the combination of perindopril and indapamide (in a single pill) plus a tablet of amlodipine (called free combination), in lowering SBP after 2 months of treatment. “Free combination” can apply to any number of pills from 2 upwards.
- Fixed [Per/Ind/Aml]
- Free [Per/Ind + Aml]
- CL3-6593-018
Eligibility Criteria
Eligible age for the study
Sexes
Male/FemaleAccepts Healthy Volunteers
NoTo take part, participants had to be:
- Men or women of Asian origin.
- 18 years of age or older.
- Diagnosed with uncontrolled high blood pressure despite a treatment. Uncontrolled means that:
- The SBP was between 140 and 180 mmHg.
- The DBP was between 90 and 110 mmHg.
Participants could not take part in the study if they:
- Were being treated for their high blood pressure with more than two drugs, or two drugs at the highest doses, at the first visit of the study.
- Had suspected or known high blood pressure due to other health issues such as, kidney problems, certain tumours or other medications.
How is the study designed?
Participants received perindopril, indapamide and amlodipine in a single pill.
The fixed combinations consisted of:
- 1 tablet of 5 mg of perindopril, 1.25 mg of indapamide and 5 mg of amlodipine or
- 1 tablet of 10 mg of perindopril, 2.5 mg of indapamide and 5 mg of amlodipine or
- 1 tablet of 10 mg of perindopril, 2.5 mg of indapamide and 10 mg of amlodipine
Participants received a combination of perindopril and indapamide (in a single pill) plus a tablet of amlodipine.
The free combination consisted of:
- 1 or 2 tablets of 4 mg of perindopril and of 1.25 mg of indapamide and
- 1 or 2 tablets of 5 mg of amlodipine.
The medication started at low dose, and then every 2 months, the dose was gradually increased, if the blood pressure was still high.
Each participant took 2 capsules orally in the morning, either:
- 1 capsule containing the fixed combination and 1 placebo capsule or
- 1 capsule containing perindopril and indapamide and 1 capsule containing amlodipine.
The placebo looks like the treatment but does not contain any real medicine.