ImpotencePhase 2NCT00174486
Assessment Of Duration Of Action, Safety & Toleration Of UK369,003 and Cialis In Patients With Erectile Dysfunction
A Phase 2 study testing UK0369,003 and Cialis (Tadalafil) in people with Impotence, run by Pfizer.
Trial summary
Assessment of duration of action, safety \& toleration of different formulations and doses of UK-369,003 and Cialis in patients with male erectile dysfunction. Patients should have previously been on PDE5 inhibitors and have been respondents to the drug. Duration of treatment is 4 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Impotence
- What is being tested?
- UK0369,003 and Cialis (Tadalafil)
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Feb 2005to Jun 2005
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Erectile Dysfunction
Who cannot join
- Alpha blockers and Nitrates of any preparation
About this study
Official title: A Double Blind, Placebo Controlled, Parallel Group, Multicenter Study To Assess The Duration Of Action, Safety And Toleration Of Differing Doses and Combinations Of Immediate and Modified Release Formulations Of UK-369,003 and Cialis Compared To Placebo In Adult Male Subjects With Erectile Dysfunction
Assessment of duration of action, safety \& toleration of different formulations and doses of UK-369,003 and Cialis in patients with male erectile dysfunction. Patients should have previously been on PDE5 inhibitors and have been respondents to the drug. Duration of treatment is 4 weeks.
- Conditions
- Impotence
- Being tested
- UK0369,003, Cialis (Tadalafil)
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UK0369,003Drug
Cialis (Tadalafil)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of duration of action, safety & toleration of the investigational drug and Cialis
Secondary outcomes (1)
Assess safety & toleration over 4 week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startFeb 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImpotenceStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174486
- Sponsor's protocol ID
- A3711030
- Status last verified
- Nov 2005
- First submitted
- 12 Sep 2005
- Last updated
- 25 Jul 2006
- Results posted
- No