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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00608153
Other study ID # NIS-CGE-ATA-2007/1
Secondary ID
Status Completed
Phase N/A
First received January 23, 2008
Last updated February 5, 2008
Start date January 2007
Est. completion date September 2007

Study information

Verified date January 2008
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 1773
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- essential hypertension

- under candesartan treatment

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Outcome

Type Measure Description Time frame Safety issue
Primary 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. app. 3 monthly
Secondary 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 app. 3 monthly
Secondary To assess under naturalistic conditions the subject's reason(s) for withdrawal of the pre-scribed dose of candesartan or candesartan/HCT app. 3 monthly
Secondary 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 app. 3 monthly
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