PAR-R13-001: PARADIGHM (Physicians Advancing Disease Knowledge in Hypoparathyroidism): A Registry for Patients with Chronic Hypoparathyroidism

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45599
• EU PAS number:
  EUPAS16927
• Study ID:
  45599
• Official title and acronym:
  PAR-R13-001: PARADIGHM (Physicians Advancing Disease Knowledge in Hypoparathyroidism): A Registry for Patients with Chronic Hypoparathyroidism
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Canada

  Denmark

  Germany

  Greece

  Italy

  Norway

  Spain

  Sweden

  United Kingdom

  United States
• Study description:
  The main aim of this study is to find out the long-term safety and effectiveness profile of recombinant human parathyroid hormone (1-84) (rhPTH1-84) treatment in participants with chronic hypoparathyroidism under conditions of routine clinical practice. Participants will be treated according to their clinic’s standard practice determined by the treating doctors. Each participant will fill out a study questionnaire during a routine doctor visit.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Takeda

Study timelines

Date when funding contract was signed

Actual: 13/05/2013

Study start date

Planned: 01/07/2013

Actual: 01/07/2013

Date of final study report

Planned: 01/06/2035

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Shire

Study protocol

Initial protocol

PAR-R13-001-protocol-original-redact.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)
• Regulatory procedure number:
  EMEA/H/C/PSP/S/0058.1

Other study registration identification numbers and links

NCT01922440,https://clinicaltrials.gov/ct2/show/NCT01922440?term=PAR-R13-001&rank=1