Status:
TERMINATED
Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus
Lead Sponsor:
Sanofi
Conditions:
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess efficacy and safety of volinanserin in the population of patients complaining of sleep maintenance insomnia. The objective of the substudy is to assess glycemic ...
Eligibility Criteria
Inclusion
- Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria
- Disturbances of sleep maintenance criteria based on participant's information related to sleep pattern during the preceding month
- Sub-study :
- Participants will be included if they have an established medical diagnosis of type II Diabetes Mellitus, and have been treated either with an oral hypoglycemic agent and/or insulin for at least three months prior to the Screening Visit (with stable regimen for at least one month prior to screening)
Exclusion
- Females who are lactating or who are pregnant
- Night shift workers, and individuals who nap 3 or more times per week over the preceding month
- Consumption of xanthine-containing beverages (i.e. tea, coffee, cola) comprising more than 5 cups/day
- Participation in another trial having received study medication within 1 month before the screening visit
- Body Mass Index ≥ 33
- Use of over-the-counter medications such as tryptophan, valerian root, kava, melatonin, St. John's Wort, Alluna or prescription sleep medication
- Use of any substance with psychotropic effects or properties know to affect sleep/wake
- History of primary hypersomnia, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, parasomnia, dyssomnia
- Clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder
- Positive qualitative urine drug screen (opiates, cocaine, amphetamine…)
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
1847 Patients enrolled
Trial Details
Trial ID
NCT00464061
Start Date
April 1 2007
End Date
March 1 2009
Last Update
May 26 2016
Active Locations (22)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
3
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
4
Sanofi-Aventis Administrative Office
Vienna, Austria