Real-world Aliskiren Use in Diabetic Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01393860

Enrollment

200

Registered

2011-07-13

Start date

2010-12-31

Completion date

Unknown

Last updated

2011-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hypertension

Keywords

Diabetes, aliskiren, hypertension, renal impairment

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Measure: Change in blood pressure	baseline and 1 year

Secondary

Measure	Time frame
Measure: Change in urine microalbumin	baseline and 1 year
Measure: Change in creatinine	baseline and 1 year
Measure: Change in potassium levels	baseline and 1 year

Countries

United States

Outcome results