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Trial record 1 of 1 for:    NCT00415428
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A Quality Ensuring Project With Focus On Patients With Cardiovascular Diseases As Well As Type 2 Diabetes.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00415428
Recruitment Status : Completed
First Posted : December 22, 2006
Last Update Posted : April 22, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date December 20, 2006
First Posted Date December 22, 2006
Last Update Posted Date April 22, 2015
Study Start Date January 2007
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Quality Ensuring Project With Focus On Patients With Cardiovascular Diseases As Well As Type 2 Diabetes.
Official Title Patient And Physician Alliance -Guideline Education Treatment Optimization
Brief Summary The overall objective is to increase the adherence to national guidelines for patients with established CVD and/or Type 2 diabetes by means of repeated post-graduate educational meetings and regular evaluation of the optimisation initiatives, demonstrated by improvement of goal attainment in general practice.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Primary care clinic patients
Condition
  • Heart Diseases
  • Diabetes Mellitus, Type 2
Intervention Behavioral: Patient adherence to national educational guidelines.
Study Groups/Cohorts 1.
Intervention: Behavioral: Patient adherence to national educational guidelines.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 5, 2009)
2776
Original Enrollment
 (submitted: December 20, 2006)
4000
Actual Study Completion Date September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects had to meet all of the inclusion criteria to be eligible for enrollment into the study. The following subjects qualify for inclusion in the study:
  • Subjects for whom measurement of total cholesterol, low density lipoprotein (LDL) cholesterol, blood pressure (BP) and glycosylated hemoglobin (HbA1c) was planned independently of this observational study and for whom baseline values were or became available.
  • Subjects with known CVD diagnosed > or = 6 months before inclusion
  • Previous myocardial infarction
  • Ischemic heart disease (stable and unstable angina pectoris)
  • Ischemic apoplexy
  • Peripheral arterial disease
  • And/Or
  • Subjects with T2D diagnosed > or = 6 months before inclusion
  • At least 50% of the subjects had to have CVD as the primary diagnosis. It was allowed for a secondary diagnosis to be <6 months before inclusion.

Exclusion Criteria:

  • Subjects presenting with any of the following were not to be included in the study:
  • Life expectancy of < or = 2 years
  • Unable/unwilling to understand/follow instructions
  • Taking part in a clinical study involving an investigational drug
  • Followed by a specialist for their CVD and/or T2D at the time of inclusion in the study
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries Denmark
 
Administrative Information
NCT Number NCT00415428
Other Study ID Numbers A2581154
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2015