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Compliance of Patients With Essential Hypertension Treated With Candesartan or Candesartan/Hydrochlorothiazide (CoCa)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00608153
First received: January 23, 2008
Last updated: February 5, 2008
Last verified: January 2008
History of Changes
  Purpose

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.


Condition
Essential Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Compliance of Patients With Essential Hypertension Treated With Candesartan or Candesartan/Hydrochlorothiazide

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome 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 Outcome 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 ]

Enrollment: 1773
Study Start Date: January 2007
Study Completion Date: September 2007
Groups/Cohorts
1
Patient with essential hypertension under treatment with candesartan or candesartan HCT

  Eligibility

Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

primary care ambulant patient

Criteria

Inclusion Criteria:

  • essential hypertension
  • under candesartan treatment

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00608153

Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: R. E. Schmieder, MD University hospital Erlangen-Nurnberg
Study Chair: Andrea Pahor, MD MED Dep., AstraZeneca Germany
  More Information

No publications provided

Responsible Party: Andrea Pahor, AstraZeneca Germany
ClinicalTrials.gov Identifier: NCT00608153     History of Changes
Other Study ID Numbers: NIS-CGE-ATA-2007/1
Study First Received: January 23, 2008
Last Updated: February 5, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
essential hypertension
ARB
compliance
candesartan

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Candesartan
Candesartan cilexetil
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 23, 2013