NCT01393860

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2011

Completed
Last Updated

July 14, 2011

Status Verified

July 1, 2011

Enrollment Period

6 months

First QC Date

July 11, 2011

Last Update Submit

July 13, 2011

Conditions

DiabetesHypertension

Keywords

Diabetesaliskirenhypertensionrenal impairment

Outcome Measures

Primary Outcomes (1)

  • Measure: Change in blood pressure

    baseline and 1 year

Secondary Outcomes (3)

  • 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

Study Arms (1)

Aliskiren

Diabetic nephropathy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diabetic patients with hypertension who were initiated on aliskiren

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MODEL Clinical Research, Research Division of Bay Endocrinology Associates GBMC Physicians pavilion North

Baltimore, Maryland, MD 21204, United States

Location

MeSH Terms

Conditions

Diabetes MellitusHypertensionRenal Insufficiency

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Phamaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 11, 2011

First Posted

July 13, 2011

Study Start

December 1, 2010

Primary Completion

June 1, 2011

Last Updated

July 14, 2011

Record last verified: 2011-07

Locations

US(1)