A Cohort Study to Assess Various Safety Outcomes of Interest in Users of Aliskiren Using Claims Data

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/17549
• EU PAS number:
  EUPAS3577
• Study ID:
  17549
• Official title and acronym:
  A Cohort Study to Assess Various Safety Outcomes of Interest in Users of Aliskiren Using Claims Data
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Retrospective database cohort study using US health claims database information to assess whether under real-world conditions aliskiren – either as monotherapy or in combination – may be associated with a risk increase of certain outcomes of interest as identified in ALTITIUDE compared to other antihypertensive drugs. The study objectives are as follows: To quantify associations between aliskiren and the occurrence of select outcomes. This will involve quantification of incidence rates and relative risks of (i) cerebrovascular accidents, (ii) transient ischemic attack, (iii) myocardial infarction, (iv) heart failure leading to hospitalization, (v) acute renal failure, and (vi) end stage renal disease (ESRD) in users of aliskiren compared to users of other antihypertensive drugs.Secondary objectives are: To quantify associations between aliskiren and the occurrence of hyperkalemia and hypotension. This study will separately assess the incidence rates and relative risks of (i) hyperkalemia, (ii) hypotension, and (iii) death in users of aliskiren compared to users of other antihypertensive drugs.
• Study status:
  Finalised

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Mapi

Study timelines

Date when funding contract was signed

Actual: 11/09/2012

Study start date

Actual: 15/02/2013

Data analysis start date

Planned: 30/06/2013

Actual: 01/07/2013

Date of final study report

Planned: 31/03/2014

Actual: 17/03/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Pharma AG

Study protocol

Initial protocol

CSPP100A2414-Redacted-Protocol_11Mar2013

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)

Other study registration identification numbers and links

CSPP100A2414