Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-03 @ 6:09 PM
Study NCT ID:
NCT00503360
Status:
COMPLETED
Last Update Posted:
2008-04-24
First Post:
2007-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerability, Safety and Efficacy of SAD448 in Subjects With Ocular Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'lastUpdateSubmitDate': '2008-04-23', 'studyFirstSubmitDate': '2007-07-17', 'studyFirstSubmitQcDate': '2007-07-17', 'lastUpdatePostDateStruct': {'date': '2008-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, ECGs and vital signs from baseline up to 24 hours post-dosing.'}], 'secondaryOutcomes': [{'measure': 'Change in ocular hypertension from baseline up to 24 hours post-dosing. Systemic exposure to SAD448 following the administration of two doses.'}]}, 'conditionsModule': {'keywords': ['Ocular Hypertension', 'SAD448'], 'conditions': ['Ocular Hypertension']}, 'descriptionModule': {'briefSummary': "This study will evaluate the tolerability and safety of SAD448 and explore the compound's effect on intraocular pressure in subjects with ocular hypertension."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Key inclusion criteria:\n\n* Males and females, 18 - 65 years of age, with ocular hypertension\n* Females must be post-menopausal or surgically sterile\n\nKey exclusion criteria:\n\n* Diagnosis of glaucoma in either eye\n* A history of or current eye conditions or medical problems that would prohibit the use of an investigational drug'}, 'identificationModule': {'nctId': 'NCT00503360', 'briefTitle': 'Tolerability, Safety and Efficacy of SAD448 in Subjects With Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multicenter, Randomized, Placebo-Controlled, Double-Masked, 4-Arm Parallel Group Study to Assess the Tolerability, Safety and Efficacy of Two Doses of SAD448 in Subjects With Ocular Hypertension', 'orgStudyIdInfo': {'id': 'CSAD448B2101'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SAD448', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sydney', 'country': 'Australia', 'facility': 'Novartis Investigative site, Sydney, Australia', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}], 'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}}}}