A Pharmacodynamic Study of Dapoxetine Concomitantly Administered in Participants Taking Terazosin
Completed · Phase 1 · Has a placebo group
Conditions studied: Ejaculation
In brief
The purpose of this study is to assess the pharmacodynamics (the actions or effects a drug has on the body), pharmacokinetics (blood levels), safety, and tolerability of dapoxetine 60 mg when concomitantly administered in participants taking terazosin.
Key facts
- Study ID
- NCT01366664
- Run by
- Janssen Research & Development, LLC
- People needed
- 24
- Starts
- 2011-04-01
- Expected to finish
- 2012-04-01
- Last updated by the study team
- 2014-10-07
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- On a stable regimen of terazosin (2 to 10 mg) or doxazosin (2 to 8 mg) taken daily for at least 6 weeks for the treatment of hypertension or benign prostatic hyperplasia
- a body mass index between 18 and 35 kg/m², inclusive
- a body weight of not less than 50 kg
- supine (laying down) blood pressure measurements between 90 and 150 mmHg, inclusive
- and, diastolic blood pressure measurements no higher than 95 mmHg.
You may not qualify if…
- History of current clinically significant illness or any other illness that the investigator considers should exclude the study participant or that could interfere with the interpretation of study results
- symptomatic orthostatic hypotension (a decrease of >=20 mm Hg systolic blood pressure measured after 2 but before 3 minutes after changing from supine (laying down) to standing position)
- taking a medication that is known to cause orthostatic hypotension, other than terazosin
- and, taking more than 2 other antihypertensive medications or taking an antihypertensive medication that is excluded.
Where it is running
- Study site — Anniston, Alabama, United States
- Study site — Tempe, Arizona, United States
- Study site — Costa Mesa, California, United States
- Study site — Miramar, Florida, United States
- Study site — Knoxville, Tennessee, United States
- Study site — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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