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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2019 |
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Main ID: |
EUCTR2007-001407-37-IT |
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Date of registration:
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26/11/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A multicenter,randomized,doubleblind, placebo-controlled study of the effects of KW-3902 injectable emulsion on heart failure signs and symptoms and renal function in subjects with acute heart failure syndrome and renal impairment who are hospitalized for volume overload and require intravenous diuretic therapy - Protect-1 (CKI-301)
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Scientific title:
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A multicenter,randomized,doubleblind, placebo-controlled study of the effects of KW-3902 injectable emulsion on heart failure signs and symptoms and renal function in subjects with acute heart failure syndrome and renal impairment who are hospitalized for volume overload and require intravenous diuretic therapy - Protect-1 (CKI-301) |
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Date of first enrolment:
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25/09/2007 |
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Target sample size:
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600 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001407-37 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Czech Republic
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Germany
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Hungary
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Italy
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Netherlands
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Spain
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
History of heart failure of at least 14 days, for which oral loop diuretics were prescribed as a therapy. Hospitalized for AHFS requiring IV diuretic therapy, age >18, JVP >8cm, Creatinine clearance >20mL/min <80mL/min, systolic blood pressure >95mmHg, BNP>500
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Ongoing or planned IV therapy with positive inotropic agents, vasopressor,vasodilators or mechanical support. pregnant or breast feeding women. temperature>38C, BNP<500pg/ml, systolic blood pressure >160mmHg, History of seizure, Heart transplant
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Subjects who are hospitalized with AHFS, volume overload, who require IV diuretic therapy
MedDRA version: 9.1
Level: HLGT
Classification code 10007539
Term: Cardiac disorder signs and symptoms
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Intervention(s)
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Product Name: KW-3902IV
Pharmaceutical Form: Emulsion for infusion
CAS Number: 136199-02-5
Current Sponsor code: KW-3902IV
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Emulsion for infusion
Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Secondary Objective: Time to death or rehospitalization for heart failure at day 60
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Main Objective: The objectives of this study are to evaluate the effect of KW-3902 in on heart failure signs and symptoms, renal function and safety in subjects hospitalized with AHFS, volume overload, and renal impairment
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Primary end point(s): a 3 category based on the following definitions: treatment success, Patient unchanged, treatment failure Based on: dyspnea reported by the patient, symptoms reported by the investigator, possibility to change from IV diurutics to oral diuretics
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Secondary ID(s)
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2007-001407-37-DE
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CKI-301
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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