Real-world Aliskiren Use in Diabetic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01393860
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : July 14, 2011
Information provided by:

Brief Summary:
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.

Condition or disease
Diabetes Hypertension

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Aliskiren Use in Diabetic Patients: Who's Using it, Why, and How is it Working ?
Study Start Date : December 2010
Actual Primary Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Aliskiren
U.S. FDA Resources

Diabetic nephropathy

Primary Outcome Measures :
  1. Measure: Change in blood pressure [ Time Frame: baseline and 1 year ]

Secondary Outcome Measures :
  1. Measure: Change in urine microalbumin [ Time Frame: baseline and 1 year ]
  2. Measure: Change in creatinine [ Time Frame: baseline and 1 year ]
  3. Measure: Change in potassium levels [ Time Frame: baseline and 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Clinical Disclosure Office, Novartis Pharmaceuticals Identifier: NCT01393860     History of Changes
Other Study ID Numbers: HEORUS0081
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: July 14, 2011
Last Verified: July 2011

Keywords provided by Novartis:
renal impairment

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases