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OpenTrials
Completed

NCT Number: NCT01393860

Real-world Aliskiren Use in Diabetic Patients

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.

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Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hypertension Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Baltimore, Maryland, MD 21204, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Measure: Change in blood pressure

    Time frame: baseline and 1 year

Secondary outcomes

  1. Measure: Change in urine microalbumin

    Time frame: baseline and 1 year

  2. Measure: Change in creatinine

    Time frame: baseline and 1 year

  3. Measure: Change in potassium levels

    Time frame: baseline and 1 year

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
First posted
Jul 13, 2011
Registry last updated
Jul 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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