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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01110590
First received: April 14, 2010
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Erectile Dysfunction
Drug: BAY60-4552 + Vardenafil
Drug: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Adverse Event reporting [ Time Frame: up to 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma concentration of study drugs; Pharmacokinetic parameters: AUC, Cmax, AUC/D, Cmax;norm, Cmax/D, t1/2, tmax [ Time Frame: Day 0, 6, 13 ] [ Designated as safety issue: No ]
  • Plasma concentration of cyclic guanosine monophosphate (cGMP) [ Time Frame: Day 0, 6, 13 ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: January 2010
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: BAY60-4552 + Vardenafil
Total dose given over 14 days: 5.25 mg BAY60-4552 + 140 mg Vardenafil
Experimental: Arm 2 Drug: BAY60-4552 + Vardenafil
Total dose given over 14 days: 21.0 mg BAY60-4552 + 140 mg Vardenafil
Experimental: Arm 3 Drug: BAY60-4552 + Vardenafil
Total dose given over 14 days: 21.0 mg BAY60-4552 + 280 mg Vardenafil
Placebo Comparator: Arm 4 Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110590

Locations
Germany
Mönchengladbach, Nordrhein-Westfalen, Germany, 41061
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT01110590     History of Changes
Other Study ID Numbers: 14612, 2009-015894-11
Study First Received: April 14, 2010
Last Updated: February 21, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Erectile Dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Genital Diseases, Male
Mental Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Vardenafil
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014