Real-world Aliskiren Use in Diabetic Patients

This study has been completed.
Information provided by:
Novartis Identifier:
First received: July 11, 2011
Last updated: July 13, 2011
Last verified: July 2011

The purpose of this study is to evaluate real-world patterns of aliskiren use with a focus of change in renal function following aliskiren initiation as well as to identify "triggering events" that lead to aliskiren initiation.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Aliskiren Use in Diabetic Patients: Who's Using it, Why, and How is it Working ?

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure: Change in blood pressure [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure: Change in urine microalbumin [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]
  • Measure: Change in creatinine [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]
  • Measure: Change in potassium levels [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2010
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Diabetic nephropathy


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Diabetic patients with hypertension who were initiated on aliskiren


Inclusion Criteria:

  • Type 2 diabetes
  • Patients ages 18 yeras and older
  • Hypertension Diagnosis
  • Currently on at least 1 hypertensive medication
  • At least 2 lab measure before and after aliskiren initiation

Exclusion Criteria:

  • Inadequate chart records where microalbuminuria, serum creatinine and blood pressure data are not within 3-12 months prior to initiation of Aliskiren
  • Pregnancy
  • Development of secondary renal disease unrelated to diabetes (such as nephritis)
  • Terminal illness
  • AIDS/HIV Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its identifier: NCT01393860

United States, Maryland
MODEL Clinical Research, Research Division of Bay Endocrinology Associates GBMC Physicians pavilion North
Baltimore, Maryland, United States, MD 21204
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Phamaceuticals
  More Information

No publications provided

Responsible Party: Clinical Disclosure Office, Novartis Pharmaceuticals Identifier: NCT01393860     History of Changes
Other Study ID Numbers: HEORUS0081
Study First Received: July 11, 2011
Last Updated: July 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Novartis:
renal impairment

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on April 17, 2014