|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
9 October 2012 |
|
Main ID: |
EUCTR2008-000536-40-DE |
|
Date of registration:
|
17/04/2008 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
|
|
Scientific title:
|
Pivotal phase III trial to investigate the efficacy and safety of an Orodispersible Tablet vardenafil versus placebo in the treatment of men with Erectile dysfunction (ED) - a fixed-dose, double-blind, raNdomized multi-center Trial - POTENT I - POTENT I |
|
Date of first enrolment:
|
20/08/2008 |
|
Target sample size:
|
350 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000536-40 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: fixed dose
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Belgium
|
France
|
Germany
|
Netherlands
|
Spain
| | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
1) Males 18 years-of-age or older.
2) Stable, heterosexual relationship for at least 6 months.
3) 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 Development Panel on Impotence.1
4) The subject must make at least four attempts at sexual intercourse on four separate days during the untreated baseline period (according to the answer to the following question in the Subject Diary: “Was sexual activity initiated with the intention of intercourse?”) (to be fulfilled at visit 2).
5) At least 50% of attempts at sexual intercourse during the untreated baseline period must be unsuccessful, according to the following questions from the Subject Diary (at least one question should be answered with a “No”): a)“Were you able to achieve at least some erection (some enlargement of the penis)?” b)“Were you able to insert your penis in your partner’s vagina?” c)”Did your erection last long enough for you to have successful intercourse?” (to be fulfilled at visit 2).
6) Subjects highly motivated to obtain treatment for erectile dysfunction.
7) Documented, dated, written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1) Any underlying cardiovascular condition, including unstable angina pectoris that would preclude sexual activity according to the NIH consensus report.1
2) History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1 (= screening).
3) Uncontrolled atrial fibrillation / flutter at screening (defined as ventricular response rate = 100 bpm).
4) Bleeding disorder.
5) History of surgical 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.
6) Hereditary degenerative retinal disorders such as retinitis pigmentosa.
7) History of loss of vision because of NAION, temporary or permanent loss of vision, including unilateral loss of vision.
8) Presence of penile anatomical abnormalities (e.g. penile fibrosis or Peyronie’s disease) which, in the investigator’s opinion, would significantly impair sexual performance.
9) Subjects who have been confirmed with phenylketonuria (PKU).
10) Primary hypoactive sexual desire.
11) Spinal cord injury.
12) Severe chronic or acute liver disease, history of moderate (Child-Pugh B), or severe (Child-Pugh C) hepatic impairment.
13) Clinically significant chronic hematological disease which may lead to priapism such as sickle cell anemia, multiple myeloma, and leukemia.
14) Active peptic ulceration.
15) Resting hypotension (a resting systolic blood pressure of < 90 mm Hg) or hypertension (a resting systolic blood pressure > 170 mm Hg or a resting diastolic blood pressure > 110 mm Hg).
16) History of syncope within the last 6 months prior to entry into the study.
17) History of malignancy within the past 5 years (other than squamous or basal cell skin cancer).
18) History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C.
19) Symptomatic postural hypotension within 6 months of Visit 1.
20) Any unstable medical, psychiatric, or substance abuse disorder that in the opinion of the investigator is likely to affect the subject's ability to complete the study or precludes the subject’s participation in the study.
21) History of congenital QT prolongation.
22) History of uni- or bilateral hearing loss
4.2.2.2 Concomitant medication
1) Subjects who are taking nitrates or nitric oxide donors.
2) Subjects who are exposed to androgens irrespective of their mode of administration.
3) Subjects who are taking anti-androgens. Clarification: 5alpha-reductase inhibitors, commonly not classified as anti-androgens, are permitted.
4) Subjects who are taking alpha-blockers.
5) Subjects who are taking the following potent inhibitors of cytochrome P450 3A4: HIV protease inhibitors such as ritonavir or indinavir, the anti-mycotic agents itraconazole or ketoconazole (topical forms are allowed), and the macrolide antibiotics clarithromycin and erythromycin.
6) Subjects who have received any investigational drug (including placebo) within 30 days of Visit 1.
7) Use of any treatment for ED within 7 days of Visit 1 or during the study including oral medications, vacuum devices, constrictive devices, injections, urethral suppositories, gels, any over-the-counter or non-prescription medications, and products purchased via the internet.
8) Subjects who are taking medication known to prolong QT interval, such as Type Ia and Type 3 anti-arrhythmics.
4.2.2.3 Abn
Age minimum:
Age maximum:
Gender:
Female: no
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Erectile Dysfunction (ED)
MedDRA version: 9.1
Level: LLT
Classification code 10061461
Term: Erectile dysfunction
|
|
Intervention(s)
|
Product Name: Vardenafil ODT 10 mg
Product Code: BAY 38-9456
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: Vardenafil
CAS Number: 224785-91-5
Current Sponsor code: BAY 38-9456
Other descriptive name: vardenafil hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Orodispersible tablet
Route of administration of the placebo: Oral use
|
|
Primary Outcome(s)
|
|
Primary end point(s): See objectives.
|
Secondary Objective: Secondary efficacy variables include:
- Percentage of subjects achieving “back to normal” erectile function (IIEF-EF >= 26) at visit 4 (week 12) or LOCF;
- All diary questions other than SEP 2 and 3 concerning erectile function administered over the entire treatment period;
-Number of sexual attempts under medication till first successful attempts (SEP)
- Treatment Satisfaction Scale (TSS) to be administered at the randomization visit and the final visit (or at Premature Discontinuation).
- A Global Assessment Question (GAQ) concerning the overall effect on erectile function to be administered at the final visit only.
|
Main Objective: The primary objective of this study is to compare the efficacy and safety of vardenafil ODT 10 mg (PRN) after 12 weeks of treatment or LOCF with placebo in a general population of men with erectile dysfunction. In this study, 50% of the men on active treatment have to be 65 years-of-age or older.
Primary efficacy variables are:
- IIEF-EF Domain score at visit 4 (week 12) or LOCF
- SEP 2 (success rates of penetration) and SEP 3 (maintenance of erection) at visit 4 (week 12) overall (co-primary variable)
|
|
Secondary ID(s)
|
|
2008-000536-40-NL
|
|
BAY38-9456/12093
|
|
none
|
|
Source(s) of Monetary Support
|
|
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|