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| ID | Type | Description | Link |
|---|---|---|---|
| HARECCTR0500057 |
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The purpose of this study is to investigate the interaction between doxazosin GITS and vardenafil on blood pressure (Both systolic and diastolic blood pressure) in patients with both ED and BPH.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vardenafil 10mg | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Mean maximal change of the standing systolic blood pressure (SBP) from half hour prior to till six hour after administration of the drug (baseline) with vardenafil administration versus placebo | From half hour prior to till six hour after administration of the drug (baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean maximal post-baseline change of the standing and supine diastolic blood pressure (DBP) | From half hour prior to till six hour after administration of the drug (baseline) | |
| Mean maximal post-baseline change supine SBP, and (3) the pattern of changes of the SBP and DBP from half hour prior to till six hours after administration of the drug |
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Inclusion Criteria:
Age between 50 to 80 years old
Clinically diagnosed to have lower urinary tract symptoms secondary to BPH:
Currently on regular doxazosin GITS once-daily for at least 4 weeks without clinically significant side effects
Complaints of erectile dysfunction with Erectile Function domain (EF) of the International Index of Erectile Function (IIEF) score <= 21
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chi Fai Ng, Dr | Department of Surgery, Division of Urology, The Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Hong Kong | China |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069058 | Vardenafil Dihydrochloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| From half hour prior to till six hour after administration of the drug (baseline) |
| D052801 |
| Male Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D010879 |
| Piperazines |