Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000209594
Ethics application status
Approved
Date submitted
19/05/2006
Date registered
30/05/2006
Date last updated
30/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomized, Single-Blind, Placebo-Controlled Crossover, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of UROCORTIN II in Healthy Subjects and in Patients with moderate CHF
Scientific title
A Randomized, Single-Blind, Placebo-Controlled Crossover, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of UROCORTIN II in Healthy Subjects and in Patients with moderate Congestive Heart Failure (CHF).
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy subjects and patients with moderate heart failure 1187 0
Condition category
Condition code
Cardiovascular 1270 1270 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
UROCORTIN 2 at doses of 25mcg and 100mcg infused intravenously, over 1 hour, in random order, two weeks apart.
Intervention code [1] 1053 0
None
Comparator / control treatment
Placebo infused intravenously, over 1 hour, in random order, two weeks apart.
Control group
Dose comparison

Outcomes
Primary outcome [1] 1716 0
This is a Phase 1 trial so it is designed to evaluate the safety and tolerability of UROCORTIN 2 at various dose levels. Assessed parameters are non-invasive haemodynamic, neurohormones and renal function.
Timepoint [1] 1716 0
Measurements are made half an hour before, and just prior to, commencement of infusion then at half hourly intervals during infusion. At 5 minute intervals for the first 20 minutes post infusion, then half hourly until 2 hours post infusion, then hourly until 8 hours after infusion is completed.
Secondary outcome [1] 3065 0
To evaluate the pharmacokinetics of UROCORTIN 2 in healthy subjects and patients with CHF.
Timepoint [1] 3065 0
During the 1 hour infusion and for the 8 hours after.
Secondary outcome [2] 3066 0
To evaluate selected pharmacodynamic parameters of UROCORTIN 2 in healthy subjects and patients with CHF.
Timepoint [2] 3066 0
Measurements are made half an hour before, and just prior to, commencement of infusion then at half hourly intervals during infusion. At 5 minute intervals for the first 20 minutes post infusion, then half hourly until 2 hours post infusion, then hourly until 8 hours after infusion is completed.

Eligibility
Key inclusion criteria
Able to read, understand, and provide written informed consent before participating in the study- willing to remain in the study facility for approximately 16 hours on 2 occasions and return for follow-up as needed- willing to comply with all study procedures throughout the study:Additional Inclusion Criteria for CHF patients- Class II CHF and aged 18-72 inclusive.
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Volunteers who meet any one of the following criteria will be excluded from the study- any unstable medical abnormality, chronic disease, or history or presence of neurological (including cognitive disorders), hepatic, renal, cardiovascular (does not apply to CHF patients), gastrointestinal, pulmonary, or endocrine disease , or any other abnormality that could interfere with the pharmacokinetics or pharmacodynamics evaluations of the study drug- any abnormalities in cardiovascular history (does not apply to CHF patients)- a history of malignancy- an unstable psychological disorder according to DSM-IV criteria within the past year -a history of inability to comply fully with all procedural aspects of this study (-a clinically significant illness within 30 days before dosing-a clinically significant abnormal finding upon physical examination, ECG, or clinical laboratory testing as determined by the investigator -consumed more than two alcoholic beverages per day or more than 14 alcoholic beverages per week within 14 days of dosing- consumed alcohol within 48 hours before dosing- used nicotine-containing products (including, but not limited to, tobacco, gum, patches) within 90 days before dosing - used steroids, corticosteriods, or glucocorticosteriods by any route of administration on a chronic or regular basis within 3 months before dosing -used any prescription medication or OTC medication within 72 hours before dosing - used alternative remedies or supplements within 48 hours before dosing -used any investigational drug within 1 month before dosing-had a significant blood loss greater than 500 mL or donated blood within 30 days of dosing -a positive test result for human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCV-Ab) or history of a positive result-a positive alcohol plasma sample or urine drug screen result at screening or at baseline -currently abusing analgesics, tranquilizers, opioids, mood-altering drugs, or have a known drug dependence according to DSM-IV criteria-allergy, hypersensitivity, or intolerance to UROCORTIN 2.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/09/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment outside Australia
Country [1] 320 0
New Zealand
State/province [1] 320 0

Funding & Sponsors
Funding source category [1] 1391 0
Government body
Name [1] 1391 0
Health Research Council Grant New Zealand
Country [1] 1391 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
National Heart Foundation New Zealand
Address
Country
New Zealand
Secondary sponsor category [1] 1224 0
Commercial sector/Industry
Name [1] 1224 0
Neurocrine Biosciences Inc
Address [1] 1224 0
Country [1] 1224 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2744 0
Christchurch
Ethics committee address [1] 2744 0
Ethics committee country [1] 2744 0
New Zealand
Date submitted for ethics approval [1] 2744 0
Approval date [1] 2744 0
Ethics approval number [1] 2744 0
CTY/03/03/040

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35661 0
Address 35661 0
Country 35661 0
Phone 35661 0
Fax 35661 0
Email 35661 0
Contact person for public queries
Name 10242 0
Mark Davis
Address 10242 0
Department of Medicine
Christchurch School of Medicine & Health Sciences
PO Box 4345
Christchurch
Country 10242 0
New Zealand
Phone 10242 0
+64 3 3641116
Fax 10242 0
+64 3 3641115
Email 10242 0
mark.davis@chmeds.ac.nz
Contact person for scientific queries
Name 1170 0
Lorraine Skelton
Address 1170 0
Department of Medicine
Christchurch School of Medicine & Health Sciences
PO Box 4345
Christchurch
Country 1170 0
New Zealand
Phone 1170 0
+64 3 3641063
Fax 1170 0
+64 3 3641115
Email 1170 0
lorraine.skelton@cdhb.govt.nz

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.