Compliance of Patients With Essential Hypertension Treated With Candesartan or Candesartan/Hydrochlorothiazide

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The CoCa study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions, i.e. under routine medical care conditions, the subject compliance as well as the efficacy and tolerability of candesartan or candesartan/HCT in subjects suffering from essential hypertension...

Brief Summary

Official Title: “Compliance of Patients With Essential Hypertension Treated With Candesartan or Candesartan/Hydrochlorothiazide”

The CoCa study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions, i.e. under routine medical care conditions, the subject compliance as well as the efficacy and tolerability of candesartan or candesartan/HCT in subjects suffering from essential hypertension.

  • Study Type: Observational
  • Study Design: Observational Model: Cohort, Time Perspective: Prospective

Arms, Groups and Cohorts in this Clinical Trial

  • : 1
    • Patient with essential hypertension under treatment with candesartan or candesartan HCT

Outcome Measures for this Clinical Trial

Primary Measures

  • To estimate under naturalistic conditions the compliance rate, defined as the number of subjects with regular intake of the prescribed dose of candesartan or candesartan/HCT as judged by the physician at the end of the observational period.
    • Time Frame: app. 3 monthly

Secondary Measures

  • To assess under naturalistic conditions the subject's reason(s) for being compliant or non-compliant with the intake of the pre-scribed dose of candesartan or candesartan/HCT
    • Time Frame: app. 3 monthly
  • To assess under naturalistic conditions the subject's reason(s) for withdrawal of the pre-scribed dose of candesartan or candesartan/HCT
    • Time Frame: app. 3 monthly
  • To assess under naturalistic conditions whether physicians are using procedures to improve the subject's compliance regarding the intake of candesartan or candesartan/HCT and to get insight in the type and effects of these procedures
    • Time Frame: app. 3 monthly

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • essential hypertension
  • under candesartan treatment

Exclusion Criteria:

    -

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

R. E. Schmieder, MD Principal Investigator University hospital Erlangen-Nurnberg  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00608153

Study ID Number: NIS-CGE-ATA-2007/1

ClinicalTrials.gov Identifier: NCT00608153

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00608153