CLINICAL TRIALS PROFILE FOR ESMIRTAZAPINE
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Clinical Trials for Esmirtazapine
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT00482612 ↗ | Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706) | Completed | Merck Sharp & Dohme Corp. | Phase 3 | The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean Total Sleep Time (TST) as recorded in sleep diaries relative to placebo. |
| NCT00506389 ↗ | A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707) | Completed | Parexel | Phase 3 | The purpose of this trial is to investigate the efficacy, safety and tolerability of esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia. |
| NCT00506389 ↗ | A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707) | Completed | Merck Sharp & Dohme Corp. | Phase 3 | The purpose of this trial is to investigate the efficacy, safety and tolerability of esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia. |
| NCT00535288 ↗ | Dose-Finding Safety and Efficacy Trial of Org 50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (177001/P06472/MK-8265-013) | Completed | Merck Sharp & Dohme Corp. | Phase 3 | To investigate efficacy and safety of 4 doses of esmirtazapine, compared to placebo, in the treatment of moderate to severe hot flushes (vasomotor symptoms) associated with the menopause. Co-primary efficacy endpoints are the frequency and severity of hot flushes after 4 and 12 weeks as compared to Baseline. |
| NCT00560833 ↗ | Dose-Finding Safety and Efficacy Trial of Org50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (46101/P06459/MK-8265-012) | Completed | Merck Sharp & Dohme Corp. | Phase 3 | The most direct treatment of vasomotor symptions (hot flushes) may be by means of 5-HT2A receptor antagonist. Mirtazapine is a potent blocker of 5-HT2A receptors and was found to be effective in reducing the number and intensity of hot flushes in preliminary trials. Also several Selective Serotonin Reuptake Inhibitors (SSRIs) and other similar compounds have been investigated to manage hot flushes, confirming the role of the serotonergic system. In the present trial, the efficacy and safety of four different doses of esmirtazapine compared to placebo was investigated in women with moderate to severe vasomotor symptoms associated with the menopause. The primary study hypothesis was that esmirtazapine would show superior efficacy to placebo. |
| NCT00561574 ↗ | A Long-Term Safety Study of Org 50081 (Esmirtazapine) in Elderly Outpatients With Chronic Primary Insomnia (176005/P05697/MK-8265-001) | Completed | Merck Sharp & Dohme Corp. | Phase 3 | The current study is a 52-week safety study in elderly outpatients with chronic primary insomnia randomized to treatment with 1.5 mg or 3.0 mg of esmirtazapine (Org 50081, SCH 900265, MK-8265) to investigate the safety and tolerability of long-term treatment with esmirtazapine in elderly patients. |
| NCT00561821 ↗ | Efficacy and Safety Study of Org 50081 (Esmirtazapine) in Elderly Participants (P05709) | Completed | Merck Sharp & Dohme Corp. | Phase 3 | This study was conducted to investigate the efficacy of treatment with Org 50081 (Esmirtazapine) compared to placebo in elderly participants with chronic primary insomnia. Primary efficacy variable is Wake time After Sleep Onset (WASO), averaged over all in-treatment time points and measured by polysomnography (PSG). |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
Clinical Trial Conditions for Esmirtazapine
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Clinical Trial Progress for Esmirtazapine
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Clinical Trial Sponsors for Esmirtazapine
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