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Efficacy Observational Study of Candesartan Cilexetil on Hypertensive Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00573742
First Posted: December 14, 2007
Last Update Posted: August 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
The purpose of this study is to observe treatment with candesartan cilexetil 16mg for 8 weeks, in uncontrolled hypertensive patients, in improvement of achieving of treatment goals and impact on blood pressure level in patients with uncontrolled hypertension treated with candesartan cilexetil.

Condition Intervention
Primary Hypertension Drug: Candesartan Cilexeotil 16mg

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-interventional Study on Uncontrolled Hypertensive Patients for Evaluating Efficacy of Candesartan Cilexetil as Monotherapy or add-on Therapy.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Enrollment: 1940
Study Start Date: September 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
  Eligibility

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
hypertensive patients not at BP target (according to ESC Guideline for the management of hypertension, 2003), already treated with candesartan cilexetil 16 mg/day
Criteria

Inclusion Criteria:

  • diagnosis of essential hypertension (mild or moderate as defined in European Guidelines of Hypertension, 2003), that are treated already with candesartan cilexetil 16mg o.d. within last 2 weeks or more, according to Romanian approved Atacand SPC. Written informed consent to allow access and use(analysis) of data collected

Exclusion Criteria:

  • Patients not to be included in the programme: patients who have any contraindication to the product as detailed in Romanian approved Atacand SPC. Use of specific concomitant medication known to present a potential safety concern according to Romanian approved SPC
  Contacts and Locations
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): NCT00573742


Locations
Romania
Research Site
Bacau, Romania
Research Site
Braila, Romania
Research Site
Brasov, Romania
Research Site
Bucuresti, Romania
Research Site
Cluj, Romania
Research Site
Constanta, Romania
Research Site
Craiova, Romania
Research Site
Galati, Romania
Research Site
Ghiroda, Romania
Research Site
Iasi, Romania
Research Site
Lugoj, Romania
Research Site
Oradea, Romania
Research Site
Pitesti, Romania
Research Site
Ploiesti, Romania
Research Site
Sibiu, Romania
Research Site
Timisoara, Romania
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Mihai Isvoranu AstraZeneca
Study Director: Gabriela Teodorescu AstraZeneca
  More Information

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00573742     History of Changes
Other Study ID Numbers: NIS-CRO-ATA-2007/1
First Submitted: December 13, 2007
First Posted: December 14, 2007
Last Update Posted: August 19, 2010
Last Verified: August 2010

Keywords provided by AstraZeneca:
hypertension

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


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