Efficacy Observational Study of Candesartan Cilexetil on Hypertensive Patients

This study has been completed.

First Received on December 13, 2007. Last Updated on August 18, 2010 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00573742

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:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: CV 11974 Candesartan cilexetil

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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

No publications provided

Responsible Party:	MC MD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00573742 History of Changes
Other Study ID Numbers:	NIS-CRO-ATA-2007/1
Study First Received:	December 13, 2007
Last Updated:	August 18, 2010
Health Authority:	Romainia: National Drug Agency

Keywords provided by AstraZeneca:

hypertension

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Candesartan cilexetil
Candesartan
Angiotensin II Type 1 Receptor Blockers

Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012