Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00003991

Trial Description

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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).

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003991
  •   2012/11/22
  •   2010/04/14
  •   no
  •   [---]*
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Secondary IDs

  •   2009-015894-11 
  •   NCT01110590  (ClinicalTrials.gov)
  •   14612  (Bayer)
  •   2009-015894-11 
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Health Condition or Problem studied

  •   Erectile Dysfunction
  •   N48.4 -  Impotence of organic origin
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Interventions/Observational Groups

  •   Drug: BAY60-4552 + Vardenafil
  •   Drug: BAY60-4552 + Vardenafil
  •   Drug: BAY60-4552 + Vardenafil
  •   Drug: Placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
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  •   Parallel
  •   I
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Primary Outcome

- Adverse Event reporting; time frame: up to 6 weeks

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Secondary Outcome

- Plasma concentration of study drugs; Pharmacokinetic parameters: AUC, Cmax, AUC/D, Cmax;norm, Cmax/D, t1/2, tmax; time frame: Day 0, 6, 13
- Plasma concentration of cyclic guanosine monophosphate (cGMP); time frame: Day 0, 6, 13

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2010/01/31
  •   37
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  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   70   Years
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Additional 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

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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

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Addresses

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    • Bayer
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    • Bayer
    • Bayer Study Director 
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    •   [---]*
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    •   [---]*
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    • Bayer
    • Bayer Study Director 
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    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2010/05/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.