Investigation of CV interactions between Mirabegron and Tamsulosin

• Research type

  Research Study

• Full title

  A study to evaluate cardiovascular interactions between mirabegron and tamsulosin. Covance: 8228746

• IRAS ID

  56519

• Contact name

  Ashley Brooks

• Sponsor organisation

  Astellas Pharma

• Eudract number

  2010-018690-38

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Mirabegron is a drug that is currently being developed for the treatment of OAB (Overactive bladder). OAB is a condition characterized by symptoms of increased frequency of urination and feeling to pass urine more frequently, with or without incontinence. Tamsulosin (Flomax©) is a drug marketed as a treatment for Benign Prostatic Hyperplasia (BPH) which is a condition affecting middle aged and elderly males. It is characterized by difficulty in passing urine. Both these conditions (OAB and BPH) may coexist quite frequently and hence the need may arise for both these drugs to be prescribed together. Tamsulosin is known to cause a decrease in blood pressure particularly upon standing, also known as orthostatic hypotension. The prevalence of orthostatic hypotension increases with age. As both tamsulosin and mirabegron may be prescribed to middle aged and elderly it is important to understand the effect of concomitant use on the cardiovascular interactions with respect to changes in blood pressure and heart rate. This will be an open-label, 2-arm study with healthy male subjects, aged 45 and over, within each arm randomized to one of two sequences. Dosing will be performed under fasted conditions in order to ensure maximum exposure to tamsulosin. Treatment arm 1 looks at the effect of mirabegron on tamsulosin and will contain 12 subjects in Sequence 1 and 12 subjects in Sequence 2. Treatment arm 2 looks at the effect of tamsulosin on mirabegron and will contain 12 subjects in Sequence 1 and 12 subjects in Sequence 2.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC05/13

• Date of REC Opinion

  23 Jun 2010

• REC opinion

  Further Information Favourable Opinion