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Sponsored by: |
Vasogen |
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Information provided by: | Vasogen |
ClinicalTrials.gov Identifier: | NCT00111969 |
The purpose of this study is to test the safety and efficacy of the Celacade™ system in reducing the risk of mortality and cardiovascular hospitalizations in patients with chronic systolic heart failure.
Condition | Intervention | Phase |
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Heart Failure, Congestive |
Device: Celacade™ system |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Effects of the Celacade™ System on Mortality and Morbidity in Patients With Chronic Heart Failure |
Estimated Enrollment: | 2016 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | November 2005 |
Evidence continues to accumulate on the importance of inflammation in the development and progression of heart failure (HF). The Celacade™ system may reduce chronic inflammation by stimulating the immune system’s physiological anti-inflammatory response. The ACCLAIM study is an international, approximately 2,000-patient, Phase III clinical research study designed to test the safety and efficacy of the Celacade™ system in reducing the risk of mortality and cardiovascular hospitalizations in patients with chronic systolic HF.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 0202 |
Study First Received: | May 26, 2005 |
Last Updated: | June 28, 2006 |
ClinicalTrials.gov Identifier: | NCT00111969 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Germany: Federal Institute for Drugs and Medical Devices; Norway: Norwegian Medicines Agency; Denmark: Danish Medicines Agency; Poland: Ministry of Health; Israel: Israeli Health Ministry Pharmaceutical Administration |
Heart failure Immune modulation therapy Inflammation Chronic systolic heart failure |
Heart Failure Heart Diseases Inflammation Heart Failure, Systolic |
Cardiovascular Diseases |