Evaluation of Atacand® (Candesartan) in Daily Medical Practice

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: February 4, 2009
Last updated: February 5, 2009
Last verified: February 2009
This open label, non-interventional study is to show the efficacy of antihypertensive treatment with Atacand in hypertensive patients. Efficacy is to be evaluated based on the difference in systolic and diastolic blood pressure at baseline and at both follow-up visits.


Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A 12-Week Open-Label Non-Interventional Evaluation of Atacand® (Candesartan) Efficacy, Tolerability, Compliance and Treatment Satisfaction in Patients With Arterial Hypertension

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Systolic and diastolic blood pressure reduction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence and reasons of treatment discontinuation [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Patient treatment satisfaction (using 5-point answering scale) as the measure of the patient's overall tolerance [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Physician overall evaluation of the therapy (using 5-point answering scale) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 750
Study Start Date: March 2006
Study Completion Date: June 2007

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients (outpatient or hospitalised) in whom Atacand is indicated according to the current Summary of product characteristics (SPC)

Inclusion Criteria:

  • a patient with arterial hypertension who has been prescribed Atacand according to physician's judgement, irrespective of the inclusion in the study

Exclusion Criteria:

  • hypersensitivity to candesartan or any other ingredient of Atacand
  • liver function impairment and/or cholestasis
  • severe renal insufficiency
  • woman of child-bearing potential and not using appropriate contraceptive measures, pregnancy or lactation
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00837720

Sponsors and Collaborators
Principal Investigator: Rok Accetto, MD University Medical Centre Ljubljana
  More Information

Responsible Party: Meta Jeras, Mr Ph, Regulatory and Medical Affairs Manager, AstraZeneca
ClinicalTrials.gov Identifier: NCT00837720     History of Changes
Other Study ID Numbers: NIS-CSI-ATA-2005/1 
Study First Received: February 4, 2009
Last Updated: February 5, 2009
Health Authority: Slovenia: Agency for Medicinal Products - Ministry of Health

Keywords provided by AstraZeneca:
blood pressure

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Candesartan cilexetil
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 30, 2016