A national, multicenter, prospective, single-arm registry PASS of pulmonary hypertension patients treated with Riociguat (Adempas®) in China (MK-4836-001) (EXPERT China)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47274
• EU PAS number:
  EUPAS39007
• Study ID:
  47274
• Official title and acronym:
  A national, multicenter, prospective, single-arm registry PASS of pulmonary hypertension patients treated with Riociguat (Adempas®) in China (MK-4836-001) (EXPERT China)
• DARWIN EU® study:
  No
• Study countries:
  China
• Study description:
  The primary objective of this study is to assess long-term safety of Adempas® in Chinese participants with pulmonary arterial hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH). In addition, the study will prospectively collect data on clinical effectiveness, resource use, and how Adempas® is used by pulmonary hypertension (PH) experts in real-world clinical practice.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck & Co.

Merck Investigational Site China

Study timelines

Date when funding contract was signed

Actual: 28/03/2017

Study start date

Actual: 26/03/2019

Data analysis start date

Actual: 27/09/2020

Date of final study report

Planned: 18/03/2021

Actual: 10/03/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharpe & Dohme LLC

Study protocol

Initial protocol

MK-4836-001-01-Prot_Final Redaction

Regulatory

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

Other study registration identification numbers and links

The Drug Clinical Trial Registration and Information Posting Platform (Center for Drug Evaluation, NMPA)：No. CTR20171218,,URL: http://www.chinadrugtrials.org.cn/index.html