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Real-world Aliskiren Use in Diabetic Patients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01393860
First received: July 11, 2011
Last updated: July 13, 2011
Last verified: July 2011
History of Changes

July 11, 2011
July 13, 2011
December 2010
June 2011   (final data collection date for primary outcome measure)
Measure: Change in blood pressure [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]
Measure: Change in blood pressure. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01393860 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Measure: Change in urine microalbumin [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Measure: Change in creatinine [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Measure: Change in potassium levels [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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Real-world Aliskiren Use in Diabetic Patients
Aliskiren Use in Diabetic Patients: Who's Using it, Why, and How is it Working ?

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.
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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

Diabetic patients with hypertension who were initiated on aliskiren
  • Diabetes
  • Hypertension
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Aliskiren
Diabetic nephropathy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
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June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01393860
HEORUS0081
Not Provided
Clinical Disclosure Office, Novartis Pharmaceuticals
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Phamaceuticals
Novartis
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP