A Randomized, Double-Blinded, Placebo-Controlled, Two-Way Crossover Study to Investigate the Safety and Toleration of Single Dose Sildenafil in Subjects Receiving Chronic UK-369,0031

Erectile Dysfunction Clinical Trial

Official title:

A Randomized, Double-Blinded, Placebo-Controlled, Two-Way Crossover Study to Investigate The Safety And Toleration Of Single Dose Sildenafil In Subjects Receiving Chronic UK-369,003.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00814736
• Other study ID #: A3711051
• Status: Completed
• Phase: Phase 1
• First received: November 3, 2008
• Last updated: December 22, 2008
• Start date: August 2008
• Est. completion date: September 2008

Study information

• Verified date: December 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial Summary

To investigate the safety and overall tolerability of co-administration two PDE5 inhibitors UK369,003 and sildenafil

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 55 Years

Eligibility

Inclusion Criteria:

• Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

• Healthy male subjects between the ages of 40 and 55 years, inclusive

• Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

• Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

• Loss of vision in one eye due to non-arteritic ischemic optic neuropathy (NAION) regardless of whether or not this event was temporally associated with the use of a PDE5 inhibitor.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Erectile Dysfunction
• Hyperplasia
• Prostatic Hyperplasia
• Urinary Bladder, Overactive

Intervention

Drug:
• UK369,003
oral tablet, once a day
• sildenafil
single oral dose on day 14 or day 17
• sildenafil matching placebo
single oral dose on day 14 or day 17

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and toleration assessed by non-leading questioning, incidence of adverse events and laboratory testing.		hours	No
Secondary	Incidence of postural hypotension.		hours	No
Secondary	Standing and supine pulse rate (PR) at each postdose time.		hours	No
Secondary	Standing systolic and diastolic blood pressure (BP) and supine systolic and diastolic BP at each postdose time.		hours	No

External Links

•   To obtain contact information for a study center near you, click here.