The special drug use-results survey on long-term use of telmisartan 80 mg/amlodipine 5 mg/hydrochlorothiazide 12.5 mg fixed dose combination tablets in Patients with Hypertension in Japan (Japanese Micatrio PMS, long term)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33818
• EU PAS number:
  EUPAS17181
• Study ID:
  33818
• Official title and acronym:
  The special drug use-results survey on long-term use of telmisartan 80 mg/amlodipine 5 mg/hydrochlorothiazide 12.5 mg fixed dose combination tablets in Patients with Hypertension in Japan (Japanese Micatrio PMS, long term)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  To evaluate real-world safety, effectiveness and appropriate use of Micatrio® Combination Tablets treatment in patients with hypertension
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

Multiple centres: 100 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 15/09/2016

Actual: 13/04/2016

Study start date

Planned: 20/01/2017

Actual: 07/02/2017

Data analysis start date

Planned: 20/01/2017

Actual: 07/02/2017

Date of final study report

Planned: 31/03/2020

Actual: 20/02/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Nippon Boehringer Ingelheim Co., Ltd.,

Study protocol

Initial protocol

1348.6_protocol_Synopsis

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only