Multiple Dose Escalation Study (14 Days) to Investigate Safety, Tolerability, PK and PD of Vardenafil and BAY60-4552
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01110590
First received: April 14, 2010
Last updated: February 21, 2013
Last verified: February 2013
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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:
MedlinePlus related topics:
Erectile Dysfunction
Drug Information available for:
Vardenafil
Vardenafil hydrochloride
Vardenafil dihydrochloride
Vardenafil hydrochloride trihydrate
U.S. FDA Resources
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 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 Sexual Dysfunction, Physiological Genital Diseases, Male Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders Vardenafil Vasodilator Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013