An Indian multicentric open label prospective post marketing

Study identification

• EU PAS number:
  EUPAS3724
• Study ID:
  40367
• Official title and acronym:
  An Indian multicentric open label prospective post marketing
• DARWIN EU® study:
  No
• Study countries:
  India
• Study description:
  This is a single arm, open label, prospective, non-interventional, post marketing surveillance study in real-life clinical setting. This study has been planned to be conducted on 100 subjects at approximately 20 sites across India. The recruitment period is 2 years. (ML28446)
• Study status:
  Ongoing

Research institutions and networks

Institutions

F. Hoffmann-La Roche

Multiple centres: 20 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/11/2012

Actual: 01/11/2012

Study start date

Planned: 28/11/2018

Actual: 05/12/2018

Date of final study report

Planned: 31/10/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Hoffmann-La Roche(Roche Products (India) Pvt, Ltd

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

ML28446