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Multiple Dose Escalation Study (14 Days) to Investigate Safety, Tolerability, PK and PD of Vardenafil and BAY60-4552

NCT01110590 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2013-02-22

No results posted yet for this study

Summary

Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in this multiple dose escalation study. In three treatments groups different dosages of BAY 60-4552 and vardenafil will be given with patients with erectile dysfunction.

Conditions

Interventions

DRUG

BAY60-4552 + Vardenafil

Total dose given over 14 days: 5.25 mg BAY60-4552 + 140 mg Vardenafil

DRUG

BAY60-4552 + Vardenafil

Total dose given over 14 days: 21.0 mg BAY60-4552 + 140 mg Vardenafil

DRUG

BAY60-4552 + Vardenafil

Total dose given over 14 days: 21.0 mg BAY60-4552 + 280 mg Vardenafil

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-04-30
Completion
2010-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01110590 on ClinicalTrials.gov