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A Study Evaluating the Efficacy and Safety of Sildenafil in Patients With Erectile Dysfunction Receiving Hemodialysis

NCT00654017 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-02-01

No results posted yet for this study

Summary

The study was done to evaluate the efficacy, safety, and tolerability of orally administered sildenafil taken as needed about one hour before sexual activity after a 10-week period in male outpatients with erectile dysfunction and severe renal failure who were on hemodialysis.

Conditions

  • Erectile Disfunction
  • Hemodialysis

Interventions

DRUG

placebo

Placebo comparator to be given per protocol.

DRUG

sildenafil

oral sildenafil citrate at an initial dose of 25 mg, which could have been up-titrated to 50 mg at Visit 3 based on the patient's efficacy, safety and tolerability responses; at Visits 4 and 5, the dose could remain the same, be increased to 100 mg, or decreased to 25 mg depending on the safety, efficacy, and tolerability

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Completion
2005-04-30

Countries

  • Brazil

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00654017 on ClinicalTrials.gov