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Sponsors and Collaborators: |
Zealand Pharma Kendle International |
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Information provided by: | Zealand Pharma |
ClinicalTrials.gov Identifier: | NCT00283361 |
The main purpose of this study is to see if the experimental drug ZP120, when given with the approved drug furosemide to patients with acute or sub-acute heart failure, can reduce the amount of fluid in the patients' lungs and make breathing easier.
Condition | Intervention | Phase |
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Heart Failure, Congestive |
Drug: ZP120 Procedure: I.v. catherization Procedure: 6-minutes walk performance Behavioral: Dyspnea severity assessment Procedure: Blood sampling for laboratory tests Procedure: ECG Procedure: Physical examination |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase II,Randomized, Double-Blind, Flexible Dose Study of ZP120 I.V. Infusion as Add-On Therapy in Patients With Acute or Sub-Acute Decompensated Chronic Heart Failure NYHA Class III-IV Treated With Furosemide |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
a) Worsening heart failure symptoms (current NYHA class III-IV). Patients must experience worsening of at least one of the symptoms described below at the time of entry into the study:
Dyspnea Symptoms:
Increased frequency of nocturnal dyspnea (awaken from sleep due to respiratory distress)
b) Clinical evidence of volume overload such as weight gain over previous few days, peripheral edema, hepatic congestion with ascites, pulmonary congestion, or pleural effusion
Exclusion Criteria:
History of or clinically significant evidence of any severe disease other than heart failure that preclude participation and complicate the evaluation of study results from the local laboratory:
Study ID Numbers: | 05-025 |
Study First Received: | January 25, 2006 |
Last Updated: | February 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00283361 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Heart Failure Heart Diseases Furosemide |
Heart Failure Heart Diseases Cardiovascular Diseases |