Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i
Unknown status
Rambam Health Care Campus
Phase 4
2007-03-01
A prospective, randomized, 3-arm parallel trial on 45 males with ED that were never exposed
to PDE5i therapy (naïve patients) will be enrolled.In each group, every patient will receive
three treatment regimes (Viagra®50mg & Levitra®10mg, Viagra®100mg, Levitra®20mg), in
different sequences of administration in such a manner that eventually each patient will
receive all regimes in a double- blinded fasion.Safety will be evaluated at pre- screening by
measuring hourly vital signs (blood pressure, heart rate)for 4 consecutive hours after taking
half-dose combination. Any decrease in blood pressure of 20 mmhg below baseline will exclude
the subject from the study. Effcacy will be evaluated by questionnaires (IIEF, Quality of
erection questionnaire, grade of erection scale, Sear, QVS and Sexual Encounter Profiles for
each sexual event). Non-parametric statistical analysis of the collected data Comparing the 3
groups will be performed.
Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines
Terminated
AstraZeneca
Phase 4
2008-09-01
The hypothesis of this study is that symptoms of anxiety, depression and insomnia; and
indices of psychosocial function will all improve, while BZ use will decrease significantly
during a twelve-week trial period of substituting quetiapine for benzodiazepines.
Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines
Terminated
Weill Medical College of Cornell University
Phase 4
2008-09-01
The hypothesis of this study is that symptoms of anxiety, depression and insomnia; and
indices of psychosocial function will all improve, while BZ use will decrease significantly
during a twelve-week trial period of substituting quetiapine for benzodiazepines.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.