Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus
Terminated
Sanofi
Phase 3
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 control in the subgroup of patients with type II diabetes mellitus.
Efficacy and Safety of Volinanserin on Sleep Maintenance Insomnia - Polysomnographic Study
Completed
Sanofi
Phase 3
The purpose of this study is to assess efficacy and safety of volinanserin in the population
of patients complaining of sleep maintenance insomnia. The patients suffering from that
condition frequently wake up during the night, their sleep is non restorative and they suffer
from a significant distress or impairment in their daily activities consecutive to insomnia.
Efficacy and Safety of M100907 on Sleep Maintenance Insomnia With a Sub-study in Stable Type II Diabetes Mellitus
Completed
Sanofi
Phase 3
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 control in the subgroup of patients with type II diabetes mellitus.
Comparison of Volinanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties
Terminated
Sanofi
Phase 3
The primary objective is to compare the potential for next-day residual effects of
volinanserin 2 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning
using the patient's sleep questionnaire during 4 weeks of treatment in patients with chronic
primary insomnia and sleep maintenance difficulties.
Secondary objectives are to compare the clinical safety of both products, including the
potential for rebound insomnia and withdrawal symptoms after treatment discontinuation, to
compare the efficacy of both products on subjective sleep parameters and to compare the
effects of both products on patient's daytime functioning.
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