Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction and Hypertension
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
Summary
Assess efficacy of Vardenafil in patients erectile dysfunction and high blood pressure
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Sexual Encounter Profile (SEP), questions 2 and 3
Secondary outcome: International Index of Erectile Function (IIEF) - EF (Erectile Function) domainGlobal Assessment Questionnaire (GAQ) Safety and tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Additional Information
Click here and search for drug information provided by the FDA. Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. Click here to find results for studies related to Bayer Healthcare products.
Starting date: February 2003
Last updated: December 15, 2014
|