A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin
NCT ID: NCT01489696
Last Updated: 2013-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2010-08-31
2011-02-28
Brief Summary
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Detailed Description
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Subjects receive 2 singles doses of tamsulosin, once in the absence of mirabegron and once in the presence of mirabegron.
24-hour Cardiovascular (CV) profiles are taken at both baseline days and after the single dose of tamsulosin /combination dose in each sequence. Regular blood samples are also taken to check for a potential Pharmacokinetic (PK) interaction.
Treatment arm 2 (effect of tamsulosin on mirabegron): Subjects are randomized into one of two sequences.
Subjects receive 2 singles doses of mirabegron, once in the absence of tamsulosin and once in the presence of tamsulosin.
24-hour CV profiles are taken at both baseline days and after the single dose of mirabegron/combination dose in each sequence. Regular blood samples are also taken to check for a potential PK interaction.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Treatment Arm 1
tamsulosin singles doses; mirabegron multiple dose
mirabegron
oral
tamsulosin
oral
Treatment Arm 2
mirabegron single doses; tamsulosin multiple dose
mirabegron
oral
tamsulosin
oral
Interventions
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mirabegron
oral
tamsulosin
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any of the liver function tests (i.e. Alanine Aminotransferase (ALT) and Asparate Aminotransferase (AST) above the upper limit of normal at repeated measures (at least one more time)
* Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever)
* Any prior clinically significant psychiatric history including hospitalization for mental health management
* Subject is at risk of urinary retention based on medical history
* Any clinically significant abnormality following the investigator's review of the pre-study physical examination, Electrocardiogram (ECG) and clinical laboratory tests
* Heart rate and/or blood pressure measurements at the screening and admission visits as follows: Heart rate \<50 or \>90 bpm; mean systolic blood pressure \<90 mm Hg or \>140 mmHg (\>160 mmHg for subjects 65 years or older); mean diastolic blood pressure \<60 mm Hg or \>90 mmHg (\>100 mmHg for subjects 65 years or older) (blood pressure measurements to be taken after subject has been resting in supine position for 5 min; heart rate will be measured automatically; both to be taken in triplicate)
* A QTc interval of \> 430 ms after repeated measurements (at least two more times), a history of syncope, orthostatic hypotension, vertigo, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)
* A hemoglobin value \<12.5 g/dl (7.8 mmol/l) and/or a hematocrit value \<37.9% and/or a Red Blood Cell count \<4.08 T/l (4080 mm3)
45 Years
MALE
Yes
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Study Manager
Role: STUDY_CHAIR
Astellas Pharma Europe B.V.
Locations
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Covance CRU Ltd
Leeds, , United Kingdom
Countries
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Other Identifiers
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2010-018690-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
178-CL-080
Identifier Type: -
Identifier Source: org_study_id