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A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | almorexant 200 mg |
|
| 2 | Experimental | almorexant 100 mg |
|
| 3 | Placebo Comparator | Placebo |
|
| 4 | Active Comparator | zolpidem 10 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| almorexant | Drug | 2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on. For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1&2 and Day 15&16 | From baseline to Day 1&2 |
| Change From Baseline to Day 15&16 in WASO | WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on. For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1&2 and Day 15&16 | From baseline to Day 15&16 |
| Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO) | sWASO was the self-reported time spent awake after sleep onset as reported in the sleep diary. For sWASO assessed at home, the mean of all available data collected between Visits 3 and 4 (i.e., after the second morning of Visit 3 and before the first evening of Visit 4) was used for Week 1&2 | From baseline to Week 1&2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS) | LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG | From baseline to Day 1&2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond Cluydts, Dr. | Cognitive and Biological Psychology, University of Brussels | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Disorders Laboratory, Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia | ||
| Monash Adult Sleep Center, Monash Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28735928 | Derived | Black J, Pillar G, Hedner J, Polo O, Berkani O, Mangialaio S, Hmissi A, Zammit G, Hajak G. Efficacy and safety of almorexant in adult chronic insomnia: a randomized placebo-controlled trial with an active reference. Sleep Med. 2017 Aug;36:86-94. doi: 10.1016/j.sleep.2017.05.009. Epub 2017 May 29. |
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There was a screening period of 14 to 28 days. Two randomized subjects (one in each almorexant (ACT-078573) dose group) did not receive double-blind study treatment. The 'Started population' was defined as those participants who were randomized and treated.
First subject, first visit was on 28 April 2008. The last subject, last visit (safety follow-up) was on 30 September 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem |
| FG001 | Almorexant 100mg | almorexant 100 mg almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| almorexant |
| Drug |
1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem |
|
| Placebo | Drug | 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem |
|
| zolpidem | Drug | 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated |
|
| Change From Baseline to Day 15&16 in LPS | LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG | From baseline to Day 15&16 |
| Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO) | sLSO was the self-reported time to fall asleep as reported in the sleep diary | From baseline to Week 1&2 |
| Clayton |
| Victoria |
| 3168 |
| Australia |
| Western Hospitpal, Private Bag | Footscray | Victoria | 3011 | Australia |
| Institute for Breathing and Sleep (IBAS) | Heidelburg | Victoria | 3084 | Australia |
| The Woolcock Institute of Medical Research | Glebe | 2050 | Australia |
| Australian Clinical Research Organisation | Kippa-Ring | 4021 | Australia |
| Melbourne Sleep Disorder Centre | Melbourne | Australia |
| Burnside Hospital Clinical Trials Centre | Toorak Gardens | 5065 | Australia |
| Westmead Hospital, Department of Respiratory | Westmead | 2145 | Australia |
| Medical University of Innsbruck, Department of Neurology | Innsbruck | Austria |
| Rudolfinerhaus | Vienna | A-1090 | Austria |
| University of Vienna - Department of Neurology | Vienna | A-1090 | Austria |
| Cliniques Universitaires Saint Luc | Brussels | Belgium |
| CH Jolimont / Sleep Disorders Center, Hospital de Jolimont | Haine-Saint-Paul | Belgium |
| Clinique Andre Vesale | Montigny Le Tilleuil | Belgium |
| Hospital St. Naum, Paediatr. Neurology | Sofia | Bulgaria |
| MHAT 'St. Marina' | Varna | Bulgaria |
| Oddeleni nasledne pece, Nemocnice Ceske Budejovice | České Budějovice | Czechia |
| Centrum pro poruchy spanku a bdeni, Neurologicka klinika | Katerinska | Czechia |
| Fakultni nemocnice Ostrava/Klinika detske neurologie SLEEP LABORATORY | Ostava-Poruba | Czechia |
| Poradna pro porchy spanku a spankova, Laborator Unimeds s.r.o. | Prague | Czechia |
| Somnocentrum Trutnov-spankova laborator, Oddeleni neurologie | Trutnov | Czechia |
| Scansleep Aps, Sovnlaegecentret | Aarhus | Denmark |
| Sovnlagecentret - Scan Sleep | Copenhagen | 1364 | Denmark |
| Scan Sleep ApS, Sovnlaegecentret | Copenhagen | Denmark |
| Tutkimuskeskus Vitalmed | Helsinki | Finland |
| Unesta Research Center | Tampere | Finland |
| University of Turku, Sleep Research Unit | Turku | Finland |
| Hopital Pellegrin | Bordeaux | France |
| Hopital Raymond Poincare | Garches | France |
| Service de Neurologie B, Hopital Gui de Chauliac | Montpellier | France |
| Hopital Pitie-Salpetriere | Paris | 75651 | France |
| Centre du Sommeil et de la Vigilance, Hopital Hotel Dieu de Paris | Paris | France |
| Federation des Pathologies du Sommeil | Paris | France |
| Advanced Sleep Research GmbH | Berlin | Germany |
| Charite Campus Benjamin Franklin, Klinik und Hochschulambulanz fur Psychiatrie und Psychotherapie | Berlin | Germany |
| ClinPharm International GmbH Berlin | Berlin | Germany |
| Klinische Forschung Berlin GmbH | Berlin | Germany |
| St. Hedwig-Krnkenhaus | Berlin | Germany |
| ClinPharm International GmbH Bochum | Bochum | Germany |
| ClinPharm International GmbH Chemnitz | Chemnitz | Germany |
| ClinPharm International GmbH Dresden | Dresden | Germany |
| ClinPharm International GmbH Frankfurt | Frankfurt | Germany |
| Department of Psychiatry and Psychotherapy of the University Hospital of Freiburg | Freiburg im Breisgau | Germany |
| ClinPharm International GmbH Gorlitz | Görlitz | Germany |
| Klinische Forschung | Hamburg | Germany |
| ClinPharm International GmbH Leipzig | Leipzig | Germany |
| ClinPharm International GmbH Magdeburg | Magdeburg | Germany |
| Interdisziplinäres Schlafmedizinisches Zentrum, Universitätsklinikum Giesen und Marburg GmbH | Marburg | Germany |
| ClinPharm International GmbH Potsdam | Potsdam | Germany |
| Klinik und Poliklinik fur Psychiatre | Regensburg | Germany |
| Klinische Forschung Schwerin GmbH | Schwerin | Germany |
| SOMNIBENE Institut fur Medizinische | Schwerin | Germany |
| Sleep Disorder Centre, State Health Centre | Budapest | H-1134 | Hungary |
| Department of Neurology , University of Debrecen | Debrecen | Hungary |
| Dept of Neurology, University of Pecs | Pécs | Hungary |
| Sleep Laboratory, Ilnd Hospital | Szeged | J-6725 | Hungary |
| Soroka University Medical Center, Unit for Sleep Research | Beersheba | 84101 | Israel |
| Technion Sleep Medicine Center, Rambam Medical Center | Haifa | 31096 | Israel |
| IRCCS Neurologico Casimiro Mondino, Centro Multidisciplinare di Medicina del Sonno, Servizio di Neurofisiopatologia | Bologna | IT-27100 | Italy |
| IRCCS Fondazione San Raffaele del Monte Tabor, Centro per i Disturbi del Sonno | Milan | 20127 | Italy |
| Centro del Sonno, Dipartimento di Neuroscienze, Clinica Neuroligica, Università di Pisa | Pisa | IT-56126 | Italy |
| Klinika Chorob Psychicznych i Zaburzen Nerwicowych ACK, Szpital AMG | Gdansk | 890-952 | Poland |
| Laboratorium Diagnostyka Snu, Pro-Medica | Krakow | 30-002 | Poland |
| Osrodek Diagnostyki i Leczenia Zaburzen Snu i Chorob Ukladu | Lodz | 92-215 | Poland |
| Instytut Psychiatrii i Neurologii, Zaklad Neurofizjologii Klinicznej | Warsaw | 02957 | Poland |
| Laboratorium Diagnostyka Snu, Pro-Medica | Warsaw | 04-730 | Poland |
| EMC Instytut Medyczny S.A | Wroclaw | 50-220 | Poland |
| I. Neurologická klinika FNsP Bratislava Nemocnica Staré Mesto | Bratislava | 81369 | Slovakia |
| Neurologicka klinika, FN L. Pasteura Kosice | Košice | 04066 | Slovakia |
| BenMed Park Clinic | Benoni | Johannesburg | South Africa |
| WITS Sleep Laboratory School of Physiology | Parktown | Johannesburg | South Africa |
| Gatesville Medical Centre | Gatesville | Western Cape | South Africa |
| Little Company of Mary Hospital | Pretoria | South Africa |
| Somerset West Trial Centre | Somerset West | South Africa |
| Hospital de la Santa Creu i Sant Pau, Unidad Framacologia Clinica | Barcelona | E-08025 | Spain |
| Instituto de Investigaciones del Sueno | Madrid | 28036 | Spain |
| Hospital Son Dureta, Unidad de Psicologia | Palma de Mallorca | 07014 | Spain |
| Hospital La Fe, Unidad de Neurofisiologi | Valencia | 46009 | Spain |
| Hospital MAZ, Unidad de Neurofisiologia y Sueno | Zaragoza | 50015 | Spain |
| Carlanderska Sömnlaboratoriet | Gothenburg | SE-144 35 | Sweden |
| Örebro University Hospital, Neurology department Sleep Unit | Örebro | Sweden |
| Aleris Fysiologlab | Stockholm | Sweden |
| KSM Zurzach Klinik fur Schlafmedizin | Bad Zurzach | CH-5330 | Switzerland |
| Psychiatric University Clinics (UPK) Basel, Sleep Medicine and Neurophysiology | Basel | CH-4025 | Switzerland |
| Centre pour l'Etude et le Traitement des Troubles du Sommeil Hopital Bell Idee | Chêne-Bourg | CH-1225 | Switzerland |
| KSM Luzern Klinik fur Schlafmedizin, c/o Klinik St. Anna | Lucerne | CH-6006 | Switzerland |
| University Hospital Zurich (USZ) Neurology Polyclinic, Center for Sleep Medicine | Zurich | CH-8091 | Switzerland |
| National Medical University n.a. O.O. BohomoletsChair of Diseases of Nervous System, City Clinical Hospital No.4, Neurological Departments I and II | Kiev | Ukraine |
| The Edinburgh Sleep Centre | Edinburgh | United Kingdom |
| The London Sleep Centre | London | United Kingdom |
| FG002 | Almorexant 200mg | almorexant 200 mg almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem |
| FG003 | Zolpidem 10mg | zolpidem 10 mg zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated |
| Completed Double-blind Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem |
| BG001 | Almorexant 100mg | almorexant 100 mg almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem |
| BG002 | Almorexant 200mg | almorexant 200 mg almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem |
| BG003 | Zolpidem 10mg | zolpidem 10 mg zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) | WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on. For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1&2 and Day 15&16 | All treated patients | Posted | Median | 95% Confidence Interval | minutes | From baseline to Day 1&2 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline to Day 15&16 in WASO | WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on. For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1&2 and Day 15&16 | All treated patients | Posted | Median | 95% Confidence Interval | minutes | From baseline to Day 15&16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO) | sWASO was the self-reported time spent awake after sleep onset as reported in the sleep diary. For sWASO assessed at home, the mean of all available data collected between Visits 3 and 4 (i.e., after the second morning of Visit 3 and before the first evening of Visit 4) was used for Week 1&2 | All treated patients with available data | Posted | Median | 95% Confidence Interval | minutes | From baseline to Week 1&2 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS) | LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG | All treated patients | Posted | Median | 95% Confidence Interval | minutes | From baseline to Day 1&2 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 15&16 in LPS | LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG | All treated patients | Posted | Median | 95% Confidence Interval | minutes | From baseline to Day 15&16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO) | sLSO was the self-reported time to fall asleep as reported in the sleep diary | All treated patients with available data | Posted | Median | 95% Confidence Interval | minutes | From baseline to Week 1&2 |
|
All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem | 0 | 177 | 64 | 177 | ||
| EG001 | Almorexant 100mg | almorexant 100 mg almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem | 2 | 186 | 65 | 186 | ||
| EG002 | Almorexant 200mg | almorexant 200 mg almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem | 1 | 176 | 61 | 176 | ||
| EG003 | Zolpidem 10mg | zolpidem 10 mg zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated | 0 | 168 | 72 | 168 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABSCESS LIMB | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| MULTIPLE SCLEROSIS | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| CALCULUS URETERIC | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HEADACHE | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| DEPRESSED MOOD | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| BALANCE DISORDER | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| NIGHTMARE | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA (12.0) | Systematic Assessment |
| |
| BLEPHAROSPASM | Eye disorders | MedDRA (12.0) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| FOOD CRAVING | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| MICTURITION URGENCY | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| RESTLESSNESS | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA (12.0) | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ouali Berkani/Clinical Trial Leader | Actelion Pharmaceuticals Ltd | +41 61 565 5342 |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C519150 | almorexant |
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Austria |
|
| Belgium |
|
| Bulgaria |
|
| Czech Republic |
|
| Denmark |
|
| Finland |
|
| France |
|
| Germany |
|
| Hungary |
|
| Israel |
|
| Italy |
|
| Poland |
|
| South Africa |
|
| Spain |
|
| Sweden |
|
| Switzerland |
|
| United Kingdom |
|
| Day 1&2 |
|
| Change from baseline to day 1&2 |
|
| Wilcoxon rank-sum |
| <0.0001 |
| Median Difference (Net) |
| -26.8 |
| 2-Sided |
| 95 |
| -34.3 |
| -19.5 |
| No |
| Superiority or Other |
| Change from baseline to day 1&2 compared with placebo | Wilcoxon rank-sum | 0.0376 | Median Difference (Net) | -6.8 | 2-Sided | 95 | -13.5 | -0.3 | No | Superiority or Other |
|
|
|
zolpidem 10 mg
zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|