Real-world Aliskiren Use in Diabetic Patients

Completed

• Conditions: Diabetes; Hypertension

• Registration Number: NCT01393860
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2011-06
• Status Verified: 2011-07
• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-12
• Study First Posted: 2011-07-13
• Last Update Submitted: 2011-07-13
• Last Update Posted: 2011-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure: Change in blood pressure	baseline and 1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

MODEL Clinical Research, Research Division of Bay Endocrinology Associates GBMC Physicians pavilion North; 🇺🇸 Baltimore, Maryland, United States