Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000707662
Ethics application status
Approved
Date submitted
26/10/2005
Date registered
2/11/2005
Date last updated
19/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 2b, Randomized, Double-Blinded, Placebo-Controlled,
Multicenter Study Of Ularitide In The Treatment Of Subjects With
Acute Decompensated Heart Failure
Scientific title
A Phase 2b, Randomized, Double-Blinded, Placebo-Controlled,
Multicenter Study Of Ularitide In The Treatment Of Subjects With
Acute Decompensated Heart Failure
Universal Trial Number (UTN)
Trial acronym
Ularitide-1501
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Decompensated Heart Failure 857 0
Condition category
Condition code
Cardiovascular 923 923 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomized, 2-arm study in which ularitide (15 ng/kg/min) or placebo will
be administered IV continuously over 24 hours, in addition to standard therapy. Subjects must receive the dose of study drug within one hour after
randomization.
Intervention code [1] 736 0
None
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1208 0
To compare the safety of ularitide
(15 ng/kg/min IV over 24 hours) to placebo in subjects with
symptomatic acute decompensated heart failure.
Timepoint [1] 1208 0
Primary outcome [2] 1209 0
To compare the efficacy of ularitide
(15 ng/kg/min IV over 24 hours) to placebo in subjects with
symptomatic acute decompensated heart failure.
Timepoint [2] 1209 0
Secondary outcome [1] 2206 0
To evaluate the pharmacokinetics, pharmacodynamics,
and immunogenicity of IV ularitide in subjects with symptomatic
ADHF.
Timepoint [1] 2206 0

Eligibility
Key inclusion criteria
Adults who require hospitalization in a monitored bed for ADHF. Symptomatic ADHF (see Section 4.2 for definingcharacteristics). A negative urine pregnancy test result in women ofchildbearing potential within 24 hours of dosing. Ability of subject or authorized guardian to provide informedconsent (all sites) and permission to use protected health information (US sites only).
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Systolic blood pressure (BP) 110 or >200 mmHg at screening and within 10 minutes of study drug administration. Ongoing acute coronary syndrome, acute myocarditis orconstrictive pericarditis, obstructive hypertrophiccardiomyopathy, hemodynamically significant arrhythmias, stenotic valvular disease, or congenital heart disease; acutemyocardial infarction within 30 days of randomization. Use of restricted medications or procedures (see details in Section 4.3). Cardiogenic shock, volume depletion, severe electrolyteimbalance, renal disorder with serum creatinine >2.5 mg/dL (220 micromol/L) or planned ultrafiltration or dialysis or anyother clinical condition that would contraindicate the use of an IV vasodilator. Coronary artery bypass grafting within 90 days. Suspicion of pulmonary embolism. Cerebrovascular accident (CVA) within 180 days.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of study drug will be done Iteractive Voice Register System
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation sequence is done by computer generated system. When a patient is confirmed as eligible for the study, the Investigator will phone the IVRS system and the next treatment number available will be allocated for this patient's randomization number. The pharmacist will then prepare the study drug using the allocated subject number.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 245 0
United States of America
State/province [1] 245 0

Funding & Sponsors
Funding source category [1] 1018 0
Commercial sector/Industry
Name [1] 1018 0
Protein Design Labs Inc
Country [1] 1018 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Protein Design Labs, Inc.
Address
Country
United States of America
Secondary sponsor category [1] 882 0
Charities/Societies/Foundations
Name [1] 882 0
Icon Clinical Research Organisation will represent the sponsor in Australia
Address [1] 882 0
Country [1] 882 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Nepean Hospital Derby Street
Penrith NSW 2751 ethics submission due on 12th Oct 05.

Royal Adelaide Hospital Level 6,
Outpatients Building North Terrace,
SA 5000 ethics submission 19th Oct 05
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35353 0
Address 35353 0
Country 35353 0
Phone 35353 0
Fax 35353 0
Email 35353 0
Contact person for public queries
Name 9925 0
Lenilyn Manlapaz-Espiritu
Address 9925 0
34801 Campus Drive
Fremont CA 94555
Country 9925 0
United States of America
Phone 9925 0
+1 5105791176
Fax 9925 0
Email 9925 0
[email protected]
Contact person for scientific queries
Name 853 0
Dr Richard Shames
Address 853 0
34801 Campus Drive
Fremont CA 94555
Country 853 0
United States of America
Phone 853 0
+1 5105791176
Fax 853 0
Email 853 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.