BAY38-9456 - Pivotal Trial for Diabetes Patient | NCT00678704

Studies
BAY38-9456 - Pivotal Trial for Diabetes Patient

NCT00678704

Sponsor

Bayer

Status

Completed

Last Update Posted

Dec 19, 2014Estimated

Enrollment

790Actual

Phase

Phase 3

Conditions

Erectile Dysfunction
Diabetes Mellitus

Interventions

Levitra (Vardenafil, BAY38-9456)
Levitra (Vardenafil, BAY38-9456)
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Not provided

Completion Date

Nov 2004Actual

First Submitted Date

Apr 1, 2008

First Submission Date that Met QC Criteria

May 14, 2008

First Posted Date

May 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2014

Last Update Posted Date

Dec 19, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The superiority of BAY 38-9456 10 mg and 20 mg regimens to placebo, and of 20 mg to 10 mg was confirmed in patients with diabetes mellitus suffering from erectile dysfunction. There was no large difference in incidence rate of drug-related adverse events between 10 mg and 20 mg regimens. Overall the tolerability was considered good with both regimens.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

790Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Arm 3	Placebo Comparator	Drug: Placebo
Arm 1	Experimental	Drug: Levitra (Vardenafil, BAY38-9456)
Arm 2	Experimental	Drug: Levitra (Vardenafil, BAY38-9456)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Levitra (Vardenafil, BAY38-9456)	Drug	BAY 38-9456 10 mg tablet prior to intercourse on demand	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15		At 12 weeks after start of study drug administration using data at LOCF to account for dropouts

Secondary Outcomes

Measure	Description	Time Frame
The Global Assessment Question		At 4, 8, 12 weeks after start of study drug administration and LOCF
The IIEF EF domain score		At 4, 8, 12 weeks after start of study drug administration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male with erectile dysfunction for more than 3 years according to the National Institutes of Health (NIH) Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
Diabetes for more than 3 years

Exclusion Criteria:

Following to the labeling of Japanese package insert for vardenafil 5/10 mg, except for the highest dose
Spinal cord injury
History of surgical prostatectomy (excluding TURP)
Patients with an HbA1c > 12% at Visit 1
Use of nitrates
Use of potent CYP3a4 inhibitors
Severe liver disease
Presence of Peyronie's Disease

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D007172	Erectile Dysfunction
D003920	Diabetes Mellitus
D012735	Sexual Dysfunction, Physiological

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069058	Vardenafil Dihydrochloride

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided