Ejaculation Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-Controlled, Crossover Study Assessing the Pharmacodynamic Effects of Dapoxetine Concomitantly Administered in Subjects Taking Terazosin
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen Research & Development, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference between standing and supine blood pressure measurements | Days 1-2 | Yes | |
Primary | Difference between standing and supine blood pressure measurements | Days 5-6 | Yes | |
Secondary | Plasma concentrations of dapoxetine | Blood samples collected prior to and for 24 hours following dapoxetine/placebo administration on Days 1 and 5 of each treatment period and prior to dosing on Days 3 and 4 | No | |
Secondary | Plasma concentrations of dapoxetine metabolite desmethyldapoxetine | Blood samples collected prior to and for 24 hours following dapoxetine/placebo administration on Days 1 and 5 of each treatment period and prior to dosing on Days 3 and 4 | No | |
Secondary | Number and type of adverse events | Up to a Maximum of 26 Days | Yes | |
Secondary | Clinical laboratory test values | Up to a Maximum of 26 Days | Yes | |
Secondary | Physical examination findings | Up to a Maximum of 26 Days | Yes | |
Secondary | Vital sign measurements | Up to a Maximum of 26 Days | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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