Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00984529
First received: September 24, 2009
Last updated: January 6, 2011
Last verified: January 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Chronic Heart Failure |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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 [ Time Frame: 1 visit (after at least 6 months of treatment) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate ventricular function after at least 6 months of treatment with candesartan cilexetil [ Time Frame: 1 visit (after at least 6 months of treatment) ] [ Designated as safety issue: No ]
- To gain insight into usage of candesartan cilexetil in real life for chronic heart failure in Croatia [ Time Frame: 1 visit (after at least 6 months of treatment) ] [ Designated as safety issue: No ]
- To evaluate patient`s compliance with prescribed treatment [ Time Frame: 1 visit (after at least 6 months of treatment) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | September 2009 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Cardiologist´s office patients
|
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
Primary Care
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984529
Locations
| 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, Croatia | |
Sponsors and Collaborators
AstraZeneca
More Information
No publications provided
| Responsible Party: | MCMD, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00984529 History of Changes |
| Other Study ID Numbers: | NIS-CHR-ATA-2008/1 |
| Study First Received: | September 24, 2009 |
| Last Updated: | January 6, 2011 |
| Health Authority: | Croatia: Ethics Committee Croatia: Ministry of Health and Social Care |
Keywords provided by AstraZeneca:
|
Chronic heart failure candesartan cilexetil clinical signs symptoms |
Additional relevant MeSH terms:
|
Heart Failure Signs and Symptoms Heart 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 May 23, 2013