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Evaluation of Target Organs Damage in Hypertensive Patients (PreVENT-A GP)

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: NCT01055353
Recruitment Status : Completed
First Posted : January 25, 2010
Last Update Posted : May 12, 2011
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date January 21, 2010
First Posted Date January 25, 2010
Last Update Posted Date May 12, 2011
Study Start Date January 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 22, 2010)
To evaluate the frequency of evaluation of preclinical target organs damage in hypertensive patients with no known cardiovascular or renal disease, by taking blood pressure (controlled or uncontrolled HT*) into account [ Time Frame: once / 1 Year ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01055353 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 22, 2010)
  • To describe the patient profile (socio-demographic, risk factors, comorbidities, global CV risk level estimated by the doctor and calculated retrospectively [according to ESH 2007]) associated with screening for target organs damage
  • To describe the modalities of patient follow-up and management
  • To compare the frequency of evaluation of target organs damage as a function of the modalities of management of CV risk factors at the time of the consultation.
Original Secondary Outcome Measures Same as current
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Target Organs Damage in Hypertensive Patients
Official Title Evaluation of Target Organs Damage in Hypertensive Patients Followed in General Practice With no Known Cardiovascular (CV) or Renal Disease, Stratified According to Blood Pressure Control
Brief Summary Evaluation of target organs damage in hypertensive patients with no known cardiovascular (CV) or renal disease, stratified according to level of blood pressure control
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population First 2 consecutive adults with hypertension, with no known cardiovascular (CV) or renal disease, seen by general practitioner
Condition
  • Target Organs Damage
  • Hypertensive
  • no Known Cardiovascular
  • no Known Renal Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
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: July 26, 2010)
1857
Original Estimated Enrollment
 (submitted: January 22, 2010)
2000
Actual Study Completion Date June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • diagnosis of essential hypertension (treated or untreated); HT not discovered on the day of the consultation; no documented clinical cardiovascular or renal disease.

Exclusion Criteria:

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 France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01055353
Other Study ID Numbers NIS-CFR-DUM-2009/2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party MC CD, AstraZeneca
Study Sponsor AstraZeneca
Collaborators Not Provided
Investigators
Study Director: Pascal Piedbois AstraZeneca
PRS Account AstraZeneca
Verification Date May 2011