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Efficacy and Safety of Perindopril 5 mg / Indapamide 1.25 mg / Amlodipine 5 mg Fixed Combination in Hypertension

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Servier Protocol Code: CL3-6593-018 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT05820880

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How to participate to the study?
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you don’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 42 locations

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.

Official title: Evaluation of the Clinical Efficacy and Safety of Perindopril 5 mg / Indapamide 1.25 mg / Amlodipine 5 mg Fixed Combination in Single-pill After 2 Months of Treatment Versus Free Combination, Perindopril 4 mg / Indapamide 1.25 mg + Amlodipine 5 mg Given Separately at the Same Time, With Conditional Titration Based on Blood Pressure Control in Patients With Essential Hypertension Uncontrolled After 1 Month With Perindopril 4 mg / Indapamide 1.25 mg Bi-therapy.
Results
English (USA)
普通话 (中国)
English (USA)
Conditions
Hypertension
Interventions / Treatments
  • Fixed [Per/Ind/Aml]
  • Free [Per/Ind + Aml]
Other study id numbers
  • CL3-6593-018

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sexes

Male/Female

Accepts Healthy Volunteers

No

To 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?

Allocation
Randomized
Interventional study model
Parallel
Participant Group / Arm
Experimental: Fixed combination

Participants received perindopril, indapamide and amlodipine in a single pill.

Intervention / Treatment
Drug: Perindopril/indapamide/amlodipine

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
Participant Group / Arm
Active Comparator: Free combination

Participants received a combination of perindopril and indapamide (in a single pill) plus a tablet of amlodipine.

Intervention / Treatment
Drug: Perindopril/indapamide/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.

Keywords

Additional Relevant MeSH Terms Glioma
Hypertension