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NCT00984529 Clinical Trial

Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia

Chronic Heart Failure Clinical Trial

Official title:
Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00984529
Other study ID # NIS-CHR-ATA-2008/1
Secondary ID
Status Completed
Phase N/A
First received September 24, 2009
Last updated January 6, 2011
Start date September 2009
Est. completion date February 2010

Study information
Verified date January 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Croatia: Ethics CommitteeCroatia: Ministry of Health and Social Care
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine whether treatment with candesartan cilexetil for at least 6 months in patients with chronic heart failure improves clinical signs and symptoms of chronic heart failure.

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with diagnosed chronic heart failure

- Patients treated for at least 6 months with candesartan cilexetil

- Signed Informed consent

Exclusion Criteria:

- Hypersensitivity to candesartan cilexetil

- Pregnancy / lactation

- Severe hepatic impairment

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Croatia Research Site Biograd
Croatia Research Site Bjelovar
Croatia Reserach Site Cakovec
Croatia Research Site Karlovac
Croatia Reserach Site Krapinske Toplice
Croatia Research Site Novi Marof
Croatia Research Site Opatija
Croatia Research Site Osijek
Croatia Research Site Pula
Croatia Research Site Rijeka
Croatia Reserach Site Sl. Brod
Croatia Research Site Split
Croatia Research Site Stubicke Toplice
Croatia Reserach Site Zabok
Croatia Research Site Zagreb

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Croatia, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate clinical signs and symptoms of chronic heart failure (in terms of NYHA status, fluid retention and tiredness/fatigue) after at least 6 months of treatment with candesartan cilexetil 1 visit (after at least 6 months of treatment) No
Secondary To evaluate ventricular function after at least 6 months of treatment with candesartan cilexetil 1 visit (after at least 6 months of treatment) No
Secondary To gain insight into usage of candesartan cilexetil in real life for chronic heart failure in Croatia 1 visit (after at least 6 months of treatment) No
Secondary To evaluate patient`s compliance with prescribed treatment 1 visit (after at least 6 months of treatment) No
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