Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:53 PM
Study NCT ID:
NCT00703703
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2008-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C101207', 'term': 'darifenacin'}, {'id': 'D000068737', 'term': 'Tolterodine Tartrate'}], 'ancestors': [{'id': 'D010665', 'term': 'Phenylpropanolamine'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D003408', 'term': 'Cresols'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-01', 'studyFirstSubmitDate': '2008-06-19', 'studyFirstSubmitQcDate': '2008-06-19', 'lastUpdatePostDateStruct': {'date': '2012-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean heart rate per 24 hours following exposure to darifenacin 15 mg o.d. and tolterodine ER 4 mg o.d., at baseline and Day 7', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'Effects of darifenacin and tolterodine compared to placebo on mean heart rate per 24 hours, at baseline and Day 7 Effects of darifenacin, tolterodine and placebo on other cardiovascular parameters at baseline and Day 7', 'timeFrame': '7 days'}]}, 'conditionsModule': {'keywords': ['Heart rate, overactive bladder'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the pharmacologic effects of exposure to darifenacin and tolterodine on cardiovascular parameters in healthy subjects 50 years of age and older'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males and females ≥ 50 years\n* Body mass index equal to or greater than 18.5 kg/m2 and less than 35.0 kg/m2\n\nExclusion Criteria:\n\n* Known or suspected allergy to tolterodine ER or darifenacin or their components\n* Subjects with irregular day and night patterns such as night shift workers\n* Significant medical problems know to affect heart rate (ie., hypertension, hypotension, history of heart failure, history of pulmonary disease, etc.)\n* Medication with potential known to affect heart rate\n* History of any malignancy within the past 5 years, with the exception of localized basal cell carcinoma of the skin\n* Pregnant or nursing women\n* Subjects with diseases such as urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, severe renal insufficiency, etc.\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00703703', 'briefTitle': 'Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 3-way Cross-over, Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess Pharmacologic Effects of a 7-day Exposure to Darifenacin 15 mg o.d. and Tolterodine ER 4 mg o.d. on Cardiovascular Parameters in Healthy Subjects 50 Years of Age and Older', 'orgStudyIdInfo': {'id': 'CDAR328A2414'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Darifenacin', 'interventionNames': ['Drug: Darifenacin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Tolterodine', 'interventionNames': ['Drug: Tolterodine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Darifenacin', 'type': 'DRUG', 'otherNames': ['Enablex'], 'description': 'Darifenacin tablets 15 mg once daily', 'armGroupLabels': ['1']}, {'name': 'Tolterodine', 'type': 'DRUG', 'otherNames': ['Detrol LA'], 'description': 'Tolterodine extended release (ER) 4 mg once daily', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablet once daily', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'city': 'Riverdale', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 39.09928, 'lon': -76.5358}}, {'city': 'Wellesley Hills', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 42.30843, 'lon': -71.27867}}, {'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'city': 'Burlington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 36.09569, 'lon': -79.4378}}, {'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Procter and Gamble', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}