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OpenTrials
Completed

NCT Number: NCT05820880

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

The purpose of this study is to investigate the efficacy and safety of a fixed-dose combination of perindopril 5 mg /indapamide 1.25 mg / amlodipine 5 mg compared to the free combination of the same components (perindopril 4 mg / indapamide 1.25 mg in a single pill and amlodipine 5 mg pill given separately at the same time) in chinese patients with uncontrolled essential hypertension.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

China-Japan Friendship Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • Men or women of Asian origin
  • ≥18 years old
  • Treated for essential hypertension
  • Having the day of the selection visit an uncontrolled hypertension treated with any anti-hypertensive monotherapy at maximal dose or any dual therapy at starting dose according to investigator's routine practice or at least 1 month prior to the visit
  • Having at the selection visit a sitting SBP≥140 and <180 mmHg and DBP≥90 and <110 mmHg

Main Exclusion Criteria:

  • Known or suspected symptomatic orthostatic hypotension or positive orthostatic test at the selection visit
  • Treatment with more than 2 antihypertensive drugs or with 2 antihypertensive drugs at the highest doses at the selection visit

Treatment and study plan

Fixed [Per/Ind/Aml]

Drug

Fixed Dose combination of Perindopril/Indapamide/Amlodipine

Free [Per/Ind + Aml]

Drug

Free dose combination of Perindopril/Indapamide and Amlodipine

Primary outcomes

  1. Sitting SBP change after two months of treatment

    Time frame: Baseline safety visit, Month 2 follow-up visit

    Office sitting Systolic Blood Pressure (SBP) change from baseline to last post-baseline value over the period from Month 0 to month 2

Secondary outcomes

  1. Sitting SBP change from month 2 to month 4

    Time frame: Month 2 follow-up visit, Month 4 follow-up visit

    Office sitting Systolic Blood Pressure (SBP) change from month 2 to month 4

  2. Sitting SBP change from month 4 to month 6

    Time frame: Month 4 follow-up visit, Month 6 follow-up visit

    Office sitting Systolic Blood Pressure (SBP) change from month 4 to month 6

  3. Sitting DBP change after two months of treatment

    Time frame: Baseline safety visit, Month 2 follow-up visit

    Office sitting Diastolic Blood Pressure (DBP) change from baseline to last post-baseline value over the period from Month 0 to month 2

  4. Sitting DBP change from month 2 to month 4

    Time frame: Month 2 follow-up visit, Month 4 follow-up visit

    Office sitting Diastolic Blood Pressure (DBP) change from month 2 to month 4

  5. Sitting DBP change from month 4 to month 6

    Time frame: Month 4 follow-up visit, Month 6 follow-up visit

    Office sitting Diastolic Blood Pressure (DBP) change from month 4 to month 6

  6. Sitting Mean Arterial Pressure change after two months of treatment

    Time frame: Baseline safety visit, Month 2 follow-up visit

    Sitting Mean Arterial Pressure (MAP) change from baseline to last post-baseline value over the period from Month 0 to month 2 with MAP=2/3 DBP+1/3 SBP

  7. Sitting Mean Arterial Pressure change from month 2 to month 4

    Time frame: Month 2 follow-up visit, Month 4 follow-up visit

    Sitting Mean Arterial Pressure (MAP) change from from month 2 to month 4 , with MAP=2/3 DBP+1/3 SBP

  8. Sitting Mean Arterial Pressure change from month 4 to month 6

    Time frame: Month 4 follow-up visit, Month 6 follow-up visit

    Sitting Mean Arterial Pressure (MAP) change from from month 4 to month 6, with MAP=2/3 DBP+1/3 SBP

  9. Sitting Pulse Pressure change after two months of treatment

    Time frame: Baseline safety visit, Month 2 follow-up visit

    Sitting Pulse Pressure change from baseline to last post-baseline value over the period from Month 0 to month 2, with Pulse Pressure=SBP-DBP

  10. Response to the treatment at two months

    Time frame: Month 2 follow-up visit

    Number of patients responders, ie: with control of Blood Pressure : sitting SBP <140 mmHg and sitting DBP <90 mmHg) and/or sitting SBP decrease from baseline ≥20 mmHg or sitting DBP decrease from baseline ≥10 mmHg.

  11. Control of Blood Pressure at two months

    Time frame: Month 2 follow-up visit

    Number of patients with Blood pressure controlled, ie : with sitting SBP <140 mmHg and sitting DBP < 90 mmHg

  12. Adverse events between Month 0 and Month 2

    Time frame: Up to the 2 month follow-up visit

    Number experiencing treatment emergent adverse events between month 0 and month 2

  13. Adverse events between Month 0 and Month 6

    Time frame: Up to the 6 month final visit

    Number experiencing treatment emergent adverse events between month 0 and month 6

Sponsors and collaborators

Lead sponsor

Institut de Recherches Internationales Servier

Other

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 20, 2023
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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