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

NCT01110590 | Completed Phase 1

• 2 other identifiers: 146122009-015894-11
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Erectile Dysfunction

Keywords

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Adverse Event reporting

  up to 6 weeks

Secondary Outcomes (2)

• Plasma concentration of study drugs; Pharmacokinetic parameters: AUC, Cmax, AUC/D, Cmax;norm, Cmax/D, t1/2, tmax

  Day 0, 6, 13

• Plasma concentration of cyclic guanosine monophosphate (cGMP)

  Day 0, 6, 13

Study Arms (4)

Arm 1

EXPERIMENTAL

Drug: BAY60-4552 + Vardenafil

Arm 2

EXPERIMENTAL

Drug: BAY60-4552 + Vardenafil

Arm 3

EXPERIMENTAL

Drug: BAY60-4552 + Vardenafil

Arm 4

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BAY60-4552 + Vardenafil DRUG

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

Arm 1

Placebo DRUG

Placebo

Arm 4

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The informed consent must be signed before any study specific tests or procedures are done
• Male patients with a history of erectile dysfunction (ED) for at least 6 months, defined as "the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse" by the NIH consensus report 1993. The diagnosis of 'Erectile dysfunction' has to be confirmed by a physician
• Age: 18 to 70 years (inclusive) at the first screening examination
• Ethnicity: White
• Body mass index (BMI): equal to or above 18 and below 32 kg / m²
• Confirmation of the patient's health insurance coverage prior to the first screening examination / visit
• Ability to understand and follow study-related instructions

You may not qualify if:

• Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
• Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
• Known severe allergies, non-allergic drug reactions, or multiple drug allergies
• Any underlying cardiovascular condition, including unstable angina pectoris that would preclude sexual activity according to the NIH consensus report 1993
• History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to screening
• Bleeding disorder
• History of prostatectomy because of prostate cancer, including nerve-sparing techniques. Clarification: Any surgical procedures for the treatment of Benign Prostate Hypertrophy (BPH) are permitted, with the exception of cryosurgery, cryotherapy or cryoablation
• Hereditary degenerative retinal disorders such as retinitis pigmentosa
• History of loss of vision because of NAION (Bayer Study 12912), temporary or permanent loss of vision, including unilateral loss of vision
• History of uni- or bilateral hearing loss

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Mönchengladbach, North Rhine-Westphalia, 41061, Germany

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

BAY 60-4552; Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 14, 2010
• First Posted: April 26, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: February 22, 2013

Record last verified: 2013-02

Locations

DE (1)