| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Obstructive Sleep Apnea | Drug: ACT-541468 Drug: Placebo | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 28 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Intervention Model Description: | 2-way cross-over |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Study to Investigate the Effects of ACT-541468 on Nighttime Respiratory Function in Patients With Mild to Moderate Obstructive Sleep Apnea |
| Actual Study Start Date : | March 14, 2019 |
| Actual Primary Completion Date : | November 5, 2019 |
| Actual Study Completion Date : | November 5, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Treatment A: ACT-541468
50 mg once daily from Day 1 to Day 5 of Period A
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Drug: ACT-541468
Film-coated tablet for oral use
|
|
Placebo Comparator: Treatment B: Placebo
Matching placebo once daily from Day 1 to Day 5 of Period B
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Drug: Placebo
Film-coated tablet for oral use
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Germany | |
| Advanced Sleep Research | |
| Berlin, Germany, 10117 | |
| Study Director: | Clinical Trials | Idorsia Pharmaceuticals Ltd. |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | December 4, 2018 | ||||
| First Posted Date ICMJE | December 5, 2018 | ||||
| Last Update Posted Date | December 19, 2019 | ||||
| Actual Study Start Date ICMJE | March 14, 2019 | ||||
| Actual Primary Completion Date | November 5, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Apnea/hypopnea index (AHI) after multiple-dose administration of ACT-541468 as measured by polysomnography (PSG) [ Time Frame: After multiple-dose administration (i.e., at Night 5) (duration: 8 hours PSG recording) ] AHI is defined by total number of apnea (pause in respiration ≥ 10 s) plus hypopnea (reduction in airflow or tidal volume from pre-event baseline by 30% for at least 10 s accompanied by a decrease of SaO2 ≥ 4%) events, divided by total sleep time (TST, in min), then multiplied by 60, during TST
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures |
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| Original Other Pre-specified Outcome Measures | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study to Investigate the Effects of ACT-541468 on Nighttime Respiratory Function in Patients With Mild to Moderate Obstructive Sleep Apnea | ||||
| Official Title ICMJE | A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Study to Investigate the Effects of ACT-541468 on Nighttime Respiratory Function in Patients With Mild to Moderate Obstructive Sleep Apnea | ||||
| Brief Summary | This study is conducted to investigate the effects of ACT-541468 on nighttime respiratory function in patients with mild to moderate obstructive sleep apnea | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: 2-way cross-over Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment |
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| Condition ICMJE | Obstructive Sleep Apnea | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
28 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | November 5, 2019 | ||||
| Actual Primary Completion Date | November 5, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Germany | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03765294 | ||||
| Other Study ID Numbers ICMJE | ID-078-110 2018-002360-96 ( EudraCT Number ) |
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| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Idorsia Pharmaceuticals Ltd. | ||||
| Study Sponsor ICMJE | Idorsia Pharmaceuticals Ltd. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Idorsia Pharmaceuticals Ltd. | ||||
| Verification Date | December 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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