Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000546358
Ethics application status
Approved
Date submitted
15/10/2008
Date registered
29/10/2008
Date last updated
4/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase III-B, open randomized study to evaluate the coronary vasodilator effect of a generic or reference propatylnitrate formulation administrated in sublingual route during coronariography
Scientific title
Phase III-B, open randomized study to evaluate the coronary vasodilator effect of a generic or reference propatylnitrate formulation administrated in sublingual route during coronariography
Secondary ID [1] 252339 0
Not aplicable
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
coronariography to investigate a coronary disease 3830 0
Condition category
Condition code
Cardiovascular 4018 4018 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study has 3 arms and are going to evaluate 2 doses of a propatylnitrate generic formulation (10mg and 20mg) comparing to a propatylnitrate reference formulation (10mg).

generic propatylnitrate 10mg administrated in sublingual route, 1 tablet during coronariography.

generic propatylnitrate 20mg administrated in sublingual route, 1 tablet during coronariography.

generic propatylnitrate means that the active drug is the same from reference propatylnitrate but it will be manufactured by other company. Since the propatylnitrate pharmacokinetics does not allow to calculate bioequivalence study it was decided together with Ministry of Helath to conduct a phase III-B study.
Intervention code [1] 3554 0
Diagnosis / Prognosis
Comparator / control treatment
reference propatylnitrate 10mg administrated in sublingual route, 1 tablet during coronariography.
Control group
Active

Outcomes
Primary outcome [1] 4920 0
Vasodilator effect between a generic and a reference propatylnitrate formulation administrated in a sublingual route during coronariography. The coronariography will be performed by Judkins technic (femural access with manual injection of contrast non ionic low osmolarity named Henetix). The vasodilator effect will be measured by coronariographies images (30 images per second) and it will be recorded at a Philips Integris H500 machine (this tool is validated and described many times- Schnyder et al; Maier et al; Togni et al). The target segment to analise the drug vasodilator effect will be a 20mm segment defined by a anterior descending and circunflex arteries origin.
Timepoint [1] 4920 0
during coronariography
Secondary outcome [1] 8302 0
Verify blood pressure during all coronariography phases to evaluate drug safety
Timepoint [1] 8302 0
during coronariography

Eligibility
Key inclusion criteria
subject who was clinical indicated to investigate coronary disease;
subject who had not used a nitrate formulation or a calcium channel antagonist 12 hours before coronariography
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute miocardial infarction in less than 7 days; uncontrolled heart failure; cardiogenic arrest or haemodinamics instability; left coronary branch lesion >50%, non protected; left ventricular ejection fraction <30%; previous diagnosis of anterior decendent artery or cincurnflex occlusion; previous angioplasty with or without stent on the proximal third of the anterior decendent artery or on the circunflex; renal failure with creatinine >1,8mg/dl or patient dojng peritoneal dyalises or hemodyalisis

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 1279 0
Brazil
State/province [1] 1279 0

Funding & Sponsors
Funding source category [1] 4011 0
Commercial sector/Industry
Name [1] 4011 0
Eurofarma Laboratorios Ltda
Country [1] 4011 0
Brazil
Primary sponsor type
Commercial sector/Industry
Name
Eurofarma Laboratorios Ltda
Address
Av. Vereador José Diniz, 3465 - Sao Paulo
Country
Brazil
Secondary sponsor category [1] 3603 0
None
Name [1] 3603 0
Address [1] 3603 0
Country [1] 3603 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6091 0
Federal University of Sao Paulo
Ethics committee address [1] 6091 0
Ethics committee country [1] 6091 0
Brazil
Date submitted for ethics approval [1] 6091 0
Approval date [1] 6091 0
Ethics approval number [1] 6091 0

Summary
Brief summary
The intracoronary administration of 200 to 400 mcg of nitroglycerin is recommended before a cinecoronariography to prevent spontaneous or catheter induced spasms and to dilate the epicardic arteries and so optimize the quantification of coronary stenosis. When nitroglycerin is administrated intracoronaryly it enlarges the diameter of the coronary arteries in 10-20%, with minor enlargement in segments with major stenosis. The sublingual propatylnitrate, before the coronariography, can be an alternative to the intracoronary nitroglycerin. The main advantage of this alternative is the simplicity of the administration. However, there is no information about the coronary vasodilator effect of sublingual propatylnitrate.
The objective of this project is to compare the vasodilator effect of two formulations, the reference and the generics, of sublingual propatylnitrate during the coronariography.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29038 0
Address 29038 0
Country 29038 0
Phone 29038 0
Fax 29038 0
Email 29038 0
Contact person for public queries
Name 12195 0
Tatiana Ferian da Fonseca
Address 12195 0
Rua Borges Lagoa, 1080 - cj 101
Sao Paulo
Country 12195 0
Brazil
Phone 12195 0
55 11 5904 4454
Fax 12195 0
Email 12195 0
[email protected]
Contact person for scientific queries
Name 3123 0
Tatiana Ferian da Fonseca
Address 3123 0
Rua Borges Lagoa, 1080 - cj 101
Sao Paulo
Country 3123 0
Brazil
Phone 3123 0
55 11 5904 4454
Fax 3123 0
Email 3123 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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