ZYB117211: Plan to Assess the Incidence of Cardiovascular Related Adverse Events in Controlled Clinical Trials of Bupropion for the Treatment of Smoking Cessation

Study identification

• EU PAS number:
  EUPAS6441
• Study ID:
  48168
• Official title and acronym:
  ZYB117211: Plan to Assess the Incidence of Cardiovascular Related Adverse Events in Controlled Clinical Trials of Bupropion for the Treatment of Smoking Cessation
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The proposed investigation will evaluate the incidence of cardiovascular related deaths and serious and non-serious adverse cardiovascular events in randomized clinical trials of Bupropion marketed as Zyban (ZYB) for smoking cessation
• Study status:
  Finalised

Research institutions and networks

Institutions

Duke Clinical Research Institute (DCRI)

Study timelines

Date when funding contract was signed

Planned:31/10/2013

Actual:31/10/2013

Study start date

Planned:17/12/2013

Actual:15/02/2013

Data analysis start date

Planned:24/03/2014

Date of final study report

Planned:27/06/2014

Actual:27/06/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)