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Observatory on Elderly Patients "Les S.AGES"

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01065909
First received: February 8, 2010
Last updated: January 9, 2012
Last verified: January 2012
History of Changes

February 8, 2010
January 9, 2012
May 2009
June 2014   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01065909 on ClinicalTrials.gov Archive Site
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Observatory on Elderly Patients "Les S.AGES"
National Observatory on the Therapeutic Management in Ambulatory Care Patients Aged 65 and Over, With Diabetes Type 2, Chronic Pain or Atrial Fibrillation

Primary objective shared by the 3 registries : Describe the different pharmacotherapeutic management in patients :

  • DB (Diabetes): with type 2 diabetes, treated with oral and / or injectable antidiabetics
  • CP (Chronic Pain): with any disease leading to chronic pain (lasting for more than 3 months)
  • AF (Atrial Fibrillation): with ongoing AF or AF diagnosed within 12 months before enrollment

Secondary objectives shared by the 3 observatories:

  • Describe the occurrence of clinical events, hospitalizations and death, according to the different medical care conditions, and analyze their predicting factors
  • Estimate the resources consumption according to the medical and non medical management of these patients,
  • Analyze the impact of some factors (patient's cognitive status, autonomy, renal function ...) on the current practice

Secondary objectives specific shared by DB and AF registries :

- Analyze the geriatric pharmaco-genetic aspects

Specific secondary objectives for each observatory :

  • DB : Describe HbA1c level, percentage of responders and body weight evolution according to the different medical care conditions
  • CP : Evaluate pain consequences on Daily Living Activities and patient autonomy
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Ambulatory primary care patient over 65 years
  • Diabetes Mellitus, Type 2
  • Chronic Pain
  • Atrial Fibrillation
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  • Diabetes type 2
  • Chronic Pain
  • Atrial Fibrillation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
4500
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria specific for each observatory :

  • DB : Established type 2 diabetes treated with oral and / or injectable antidiabetics
  • CP : Pain lasting for over 3 months, requiring therapeutic care
  • FA : Ongoing Atrial fibrillation or AF diagnosed within the 12 months before enrollment and documented by ECG or Holter ECG, whatever the rhythm at inclusion

Exclusion Criteria shared by the 3 observatories:

  • Living in accommodation facility for dependent patients
  • Patient with non cardiovascular progressively unstable disease
  • Patient already enrolled in a clinical trial
  • Patient unlikely to complete the study

Exclusion Criteria specific for just AF observatory :

- Transitional AF due to thyrotoxicosis, alcohol, myocarditis, pericarditis, acute myocardial infarction, pulmonary embolism, metabolic disorders or electrocution, Post cardiac surgery AF (<3 months).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01065909
DIREG_L_04182
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP