Assessment Of Duration Of Action, Safety & Toleration Of UK369,003 and Cialis In Patients With Erectile Dysfunction

July 23, 2006 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Erectile Dysfunction

Exclusion Criteria:

  • Alpha blockers and Nitrates of any preparation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Assessment of duration of action, safety & toleration of the investigational drug and Cialis

Secondary Outcome Measures

Outcome Measure
Assess safety & toleration over 4 week treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 15, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

July 25, 2006

Last Update Submitted That Met QC Criteria

July 23, 2006

Last Verified

November 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3711030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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