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SAR407899 Single-dose in Treatment of Mild to Moderate Erectile Dysfunction (RHOKET)

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

SAR407899

Placebo

Sildenafil

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Rho-kinase inhibitor, male impotence

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

male with mild to moderate erectile dysfunction for at least 6 months
written informed consent

Exclusion Criteria:

diabetes mellitus
orthostatic hypotension
hypogonadal testosterone level

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Sequence 1

Sequence 2

Sequence 3

Sequence 4

Arm Description

Period 1: placebo Period 2: sildenafil Period 3: SAR407899 dose level 2 Period 4: SAR407899 dose level 1

Period 1: sildenafil Period 2: SAR407899 dose level 1 Period 3: placebo Period 4: SAR407899 dose level 2

Period 1: SAR407899 dose level 1 Period 2: SAR407899 dose level 2 Period 3: sildenafil Period 4: placebo

Period 1: SAR407899 dose level 2 Period 2: placebo Period 3: SAR407899 dose level 1 Period 4: sildenafil

Outcomes

Primary Outcome Measures

Duration of penile rigidity during sexual stimulation

Secondary Outcome Measures

Time to onset of penile rigidity

Blood pressure

Full Information

NCT ID

NCT00914277

First Posted

June 2, 2009

Last Updated

April 29, 2011

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00914277

Brief Title

SAR407899 Single-dose in Treatment of Mild to Moderate Erectile Dysfunction

Acronym

RHOKET

Official Title

Randomized, Double-blind, Placebo and Active Controlled Study of the Activity of SAR407899A Single-dose on the Ability to Increase Duration of Penile Rigidity, Under Experimental Condition, in Patients With Mild to Moderate Erectile Dysfunction (ED).

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of this clinical trial is to study the ability of SAR407899 to increase the duration of penile erection in male patients with mild-moderate Erectile Dysfunction. The secondary objectives of this clinical trial are to study the ability of SAR407899 to shorten increase the time to erection duration of penile erection in male patients with mild-moderate Erectile Dysfunction and to determine the overall safety and tolerability of SAR407899 in these patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

Keywords

Rho-kinase inhibitor, male impotence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sequence 1

Arm Type

Experimental

Arm Description

Period 1: placebo Period 2: sildenafil Period 3: SAR407899 dose level 2 Period 4: SAR407899 dose level 1

Arm Title

Sequence 2

Arm Type

Experimental

Arm Description

Period 1: sildenafil Period 2: SAR407899 dose level 1 Period 3: placebo Period 4: SAR407899 dose level 2

Arm Title

Sequence 3

Arm Type

Experimental

Arm Description

Period 1: SAR407899 dose level 1 Period 2: SAR407899 dose level 2 Period 3: sildenafil Period 4: placebo

Arm Title

Sequence 4

Arm Type

Experimental

Arm Description

Period 1: SAR407899 dose level 2 Period 2: placebo Period 3: SAR407899 dose level 1 Period 4: sildenafil

Intervention Type

Drug

Intervention Name(s)

SAR407899

Intervention Description

Oral administration

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral administration

Intervention Type

Drug

Intervention Name(s)

Sildenafil

Intervention Description

Oral administration

Primary Outcome Measure Information:

Title

Duration of penile rigidity during sexual stimulation

Time Frame

4 hours following drug administration

Secondary Outcome Measure Information:

Title

Time to onset of penile rigidity

Time Frame

4 hours following drug administration

Title

Blood pressure

Time Frame

12 hours following drug administration

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: male with mild to moderate erectile dysfunction for at least 6 months written informed consent Exclusion Criteria: diabetes mellitus orthostatic hypotension hypogonadal testosterone level The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lionel HOVSEPIAN, MD

Organizational Affiliation

SGS Aster Life Science Services - Paris-France

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Paris

Country

France

12. IPD Sharing Statement

Learn more about this trial

SAR407899 Single-dose in Treatment of Mild to Moderate Erectile Dysfunction

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