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NCT01393860 Clinical Trial

Real-world Aliskiren Use in Diabetic Patients

Hypertension Clinical Trial

Official title:
Aliskiren Use in Diabetic Patients: Who's Using it, Why, and How is it Working ?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01393860
Other study ID # HEORUS0081
Secondary ID
Status Completed
Phase N/A
First received July 11, 2011
Last updated July 13, 2011
Start date December 2010

Study information
Verified date July 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States MODEL Clinical Research, Research Division of Bay Endocrinology Associates GBMC Physicians pavilion North Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measure: Change in blood pressure baseline and 1 year No
Secondary Measure: Change in urine microalbumin baseline and 1 year No
Secondary Measure: Change in creatinine baseline and 1 year No
Secondary Measure: Change in potassium levels baseline and 1 year No
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