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Evaluation of Atacand® (Candesartan) in Daily Medical Practice

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00837720
First received: February 4, 2009
Last updated: February 5, 2009
Last verified: February 2009
History of Changes
  Purpose

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.


Condition
Hypertension

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:

U.S. FDA Resources

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
  Eligibility

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)

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837720

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

No publications provided

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:
hypertension
blood pressure
Atacand®
candesartan

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

ClinicalTrials.gov processed this record on May 23, 2013