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

Erectile Dysfunction Clinical Trial

Official title:

Randomized, Double-blind, Placebo-controlled, Group-comparison, Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Co-administration of Different Doses of Vardenafil (2 Dose Strengths) and BAY60-4552 (4 Dose Strengths) Given Once-daily (od) Over 14 Days in Patients With Erectile Dysfunction (ED).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110590
• Other study ID #: 14612
• Secondary ID: 2009-015894-11
• Status: Completed
• Phase: Phase 1
• First received: April 14, 2010
• Last updated: February 21, 2013
• Start date: January 2010
• Est. completion date: May 2010

Study information

• Verified date: February 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• BAY60-4552 + Vardenafil
Total dose given over 14 days: 5.25 mg BAY60-4552 + 140 mg Vardenafil
• BAY60-4552 + Vardenafil
Total dose given over 14 days: 21.0 mg BAY60-4552 + 140 mg Vardenafil
• BAY60-4552 + Vardenafil
Total dose given over 14 days: 21.0 mg BAY60-4552 + 280 mg Vardenafil
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event reporting		up to 6 weeks	Yes
Secondary	Plasma concentration of study drugs; Pharmacokinetic parameters: AUC, Cmax, AUC/D, Cmax;norm, Cmax/D, t1/2, tmax		Day 0, 6, 13	No
Secondary	Plasma concentration of cyclic guanosine monophosphate (cGMP)		Day 0, 6, 13	No

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