Status:
COMPLETED
A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Cardiovascular
Healthy Subjects
Eligibility:
MALE
45+ years
Phase:
PHASE1
Brief Summary
The study aims to compare blood pressure and pulse in male healthy subjects taking mirabegron and tamsulosin both alone and in combination.
Detailed Description
Treatment arm 1 (effect of mirabegron on tamsulosin): Subjects are randomized into one of two sequences. Subjects receive 2 singles doses of tamsulosin, once in the absence of mirabegron and once in ...
Eligibility Criteria
Inclusion
- Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2
Exclusion
- Known or suspected hypersensitivity to mirabegron and/or tamsulosin HCl, or any components of the formulations used
- 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)
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01489696
Start Date
August 1 2010
End Date
February 1 2011
Last Update
December 9 2013
Active Locations (1)
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1
Covance CRU Ltd
Leeds, United Kingdom, LS2 9LH