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Evaluation of Atacand® (Candesartan) in Daily Medical Practice

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ClinicalTrials.gov Identifier: NCT00837720
Recruitment Status : Completed
First Posted : February 5, 2009
Last Update Posted : February 6, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease
Hypertension

Study Type : Observational
Actual Enrollment : 750 participants
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
Study Start Date : March 2006
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Systolic and diastolic blood pressure reduction [ Time Frame: 12 weeks ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837720


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

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
First Posted: February 5, 2009    Key Record Dates
Last Update Posted: February 6, 2009
Last Verified: February 2009

Keywords provided by AstraZeneca:
hypertension
blood pressure
Atacand®
candesartan

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