Effectiveness of Indapamide SR on top of Perindopril on blood pressure change: a methodological study to validate effect of anti-hypertensive drugs in CPRD Aurum.

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44584
• EU PAS number:
  EUPAS44583
• Study ID:
  44584
• Official title and acronym:
  Effectiveness of Indapamide SR on top of Perindopril on blood pressure change: a methodological study to validate effect of anti-hypertensive drugs in CPRD Aurum.
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Antihypertensive treatments efficacy is demonstrated in Randomized Controlled Trials (RCT) based on frequent, iterative BP measures while these measurements are sparse in real life setting. The aim of this study is to assess whether this efficacy can be objectivised using Blood Pressure (BP) records collected in routine practice. In a main approach, this study will emulate, using Clinical Research Practice Datalink, a theoretical phase III RCT comparing the BP changes when adding indapamide SR on top of perindopril 4/5mg versus staying on perindopril 4/5mg alone, in patients who have uncontrolled hypertension.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Institut de Recherches Internationales Servier

Study timelines

Date when funding contract was signed

Planned: 01/09/2020

Actual: 01/09/2020

Study start date

Planned: 14/06/2021

Actual: 14/06/2021

Data analysis start date

Planned: 15/06/2021

Actual: 15/06/2021

Date of final study report

Planned: 29/04/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Institut de Recherches Internationales Servier

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable