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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
  Purpose

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
Diabetes
Hypertension

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:

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

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)
Groups/Cohorts
Aliskiren
Diabetic nephropathy

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01393860

Locations
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
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Phamaceuticals
  More Information

No publications provided

Responsible Party: Clinical Disclosure Office, Novartis Pharmaceuticals
ClinicalTrials.gov 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:
Diabetes
aliskiren
hypertension
renal impairment

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013