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Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction and Hypertension

A Randomized, Double-blind, Parallel-group, Plac-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administration for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Men With Arterial Hypertension and Erectile Dysfunction

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00668005
Enrollment
388
Registered
2008-04-28
Start date
2003-02-28
Completion date
2003-09-30
Last updated
2014-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction, Arterial hypertension, Vardenafil

Brief summary

Assess efficacy of Vardenafil in patients erectile dysfunction and high blood pressure

Interventions

DRUGLevitra (Vardenafil, BAY38-9456)

5mg, 10mg or 20mg taken 1h before sexual intercourse

DRUGPlacebo

Matching placebo

Sponsors

GlaxoSmithKline
CollaboratorINDUSTRY
Bayer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Men \>/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement, * Arterial hypertension adequately controlled * Stable sexual relationship for \> 6 month

Exclusion criteria

* Primary hypoactive sexual desire * History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month * Nitrate therapy

Design outcomes

Primary

MeasureTime frame
Sexual Encounter Profile (SEP), questions 2 and 312 weeks

Secondary

MeasureTime frame
International Index of Erectile Function (IIEF) - EF (Erectile Function) domain12 weeks
Global Assessment Questionnaire (GAQ)12 weeks
Safety and tolerability12 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026