Real-world Aliskiren Use in Diabetic Patients | NCT01393860

Studies
Real-world Aliskiren Use in Diabetic Patients

NCT01393860

Sponsor

Novartis

Status

Completed

Last Update Posted

Jul 14, 2011Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Diabetes
Hypertension

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Not provided

First Submitted Date

Jul 11, 2011

First Submission Date that Met QC Criteria

Jul 12, 2011

First Posted Date

Jul 13, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2011

Last Update Posted Date

Jul 14, 2011Estimated

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Label	Type	Description	Intervention Names
Aliskiren		Diabetic nephropathy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure: Change in blood pressure		baseline and 1 year

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Diabetic patients with hypertension who were initiated on aliskiren

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Phamaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MODEL Clinical Research, Research Division of Bay Endocrinology Associates GBMC Physicians pavilion North		Baltimore	Maryland	MD 21204	United States

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D006973	Hypertension
D051437	Renal Insufficiency

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided