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Sponsors and Collaborators: |
Eli Lilly and Company ICOS Corporation |
---|---|
Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00547495 |
Study to determine how safe and effective tadalafil is for Japanese men taking it when they need to get and keep an erection.
Condition | Intervention | Phase |
---|---|---|
Impotence |
Drug: tadalafil Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Tadalafil Administered "On Demand" to Patients With Erectile Dysfunction |
Enrollment: | 343 |
Study Start Date: | March 2004 |
Study Completion Date: | November 2004 |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator
Placebo tablet
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Drug: placebo
placebo tablet taken by mouth, as needed, no more than 1 dose per day, for 12 weeks
|
2: Active Comparator
5 mg tadalafil
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Drug: tadalafil
5 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
|
3: Active Comparator
10 mg tadalafil
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Drug: tadalafil
10 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
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4: Active Comparator
20 mg tadalafil
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Drug: tadalafil
20 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
|
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan, Hokkaido | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Sapporo, Hokkaido, Japan |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Study ID Numbers: | 5139, H6D-MC-LVDI |
Study First Received: | October 18, 2007 |
Last Updated: | October 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00547495 History of Changes |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Sexual Dysfunctions, Psychological Phosphodiesterase Inhibitors Sexual Dysfunction, Physiological Mental Disorders |
Tadalafil Genital Diseases, Male Erectile Dysfunction |
Sexual Dysfunctions, Psychological Phosphodiesterase Inhibitors Sexual Dysfunction, Physiological Molecular Mechanisms of Pharmacological Action Mental Disorders Tadalafil |
Enzyme Inhibitors Genital Diseases, Male Sexual and Gender Disorders Erectile Dysfunction Pharmacologic Actions |