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...
Date First Received: January 23, 2008
Last Updated: February 5, 2008
Verified by: AstraZeneca, January 2008
Clinical Trial Phase: N/A | Start Date: January 2007
Overall Status: Completed
Estimated Enrollment: 1773
Brief Summary
Official Title: “Compliance of Patients With Essential Hypertension Treated With Candesartan or Candesartan/Hydrochlorothiazide”
Condition Keyword(s):
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: Cohort, 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
- 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
- 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
- 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
- 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 Sponsor Information
Lead Sponsor: AstraZeneca
Overall Clinical Trial Officials and Contacts
R. E. Schmieder, MD Principal Investigator University hospital Erlangen-Nurnberg
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
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
Clinical Trials Authorship and Review
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