# Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus

> **NCT00464061** · PHASE3 · TERMINATED · sponsor: **Sanofi** · enrollment: 1847 (actual)

## Conditions studied

- Sleep Initiation and Maintenance Disorders

## Interventions

- **DRUG:** Volinanserin
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT00464061
- **Lead sponsor:** Sanofi
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2007-04
- **Primary completion:** 2009-03
- **Final completion:** 2009-03
- **Target enrollment:** 1847 (ACTUAL)
- **Why stopped:** Sponsor's decision due to absence of demonstration of efficacy of volinanserin in primary insomnia with predominant sleep maintenance problems
- **Last updated:** 2016-05-26


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00464061

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00464061, "Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus". Retrieved via AI Analytics 2026-07-26 from https://api.ai-analytics.org/clinical/NCT00464061. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*