Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT06566820
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-13
First Post:
2024-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continuation Protocol for Obstructive Sleep Apnea (OSA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069445', 'term': 'Atomoxetine Hydrochloride'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1280}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2024-07-03', 'studyFirstSubmitQcDate': '2024-08-20', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AES) and Serious Adverse Events (SAEs)', 'timeFrame': 'through study completion, an average of 1 year', 'description': "An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. An SAE was an AE during any study phase that fulfills one or more of the following criteria: results in death, life threatening (The term 'life-threatening' in the definition of 'serious' refers to an event in which the participant was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity."}, {'measure': 'Number of Participants With Vital Signs Abnormalities', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Vital signs that are planned to be assessed include parameters such as weight,heart rate and systolic and diastolic blood pressure.'}, {'measure': 'Number of Participants With Concomitant Therapy (Medication or Devices)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Concomitant therapy with devices (i.e., CPAP) and concomitant medications are other prescription medications, over-the-counter (OTC) drugs or dietary supplements that a study participant takes in addition to the drug under investigation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obstructive Sleep Apnea'], 'conditions': ['OSA']}, 'descriptionModule': {'briefSummary': 'The combination drug composed of aroxybutynin and atomoxetine, designated AD109, is being developed by Apnimed for the treatment of obstructive sleep apnea (OSA). The present study is a Phase 3 open label continuation protocol enrolling qualifying participants who completed one of the parent Phase 3 double-blind placebo-controlled studies, APC-APN-304 or APC-APN-305.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Completion of APC-APN-304 without permanent discontinuation of IMP.\n* Completion of APC-APN-305 without permanent discontinuation of IMP.\n\nExclusion Criteria:\n\n* Participants are excluded from the study if participation would be considered unsafe by the investigator based on the individual's current status.\n* Participants are excluded from the study if participation would be considered unsafe by the investigator based on concomitant therapies."}, 'identificationModule': {'nctId': 'NCT06566820', 'briefTitle': 'Continuation Protocol for Obstructive Sleep Apnea (OSA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Apnimed'}, 'officialTitle': 'A Phase 3 Open Label Continuation Protocol of a Fixed Dose Combination of Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': 'APC-APN-306'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AD109', 'description': 'Open Label AD109', 'interventionNames': ['Drug: Aroxybutynin and Atomoxetine']}], 'interventions': [{'name': 'Aroxybutynin and Atomoxetine', 'type': 'DRUG', 'otherNames': ['AD109'], 'description': 'Fixed Dose Combination', 'armGroupLabels': ['AD109']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35213', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Sleep Disorders Center of America', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35401', 'city': 'Tuscaloosa', 'state': 'Alabama', 'country': 'United States', 'facility': 'The University of Alabama/Institute for Rural Health Research', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Chandler Clinical Trials', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85213', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Desert Clinical Reserach, LLC/CCT Research', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85044', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Foothills Research Center/CCT Research', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Fiel Family and Sports Medicine/CCT Research', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Noble Clinical Research', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Preferred Research Partners, Inc.', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Research Institute', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90703', 'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'Core Healthcare Group', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'zip': '91910', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Exalt Clinical Research, Inc.', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Research, LLC', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 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'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Jodha Tishon, Inc.', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Ron Farkas, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Apnimed'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apnimed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}