Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT00159718
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Double Blind Atorvastatin Amlodipine Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Israel', 'Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000787', 'term': 'Angina Pectoris'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2007-01'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'From the 48 hour holter monitoring the number of ischemic episodes will be assessed at baseline (week 1), week 18 and at the final visit (week 26).'}], 'secondaryOutcomes': [{'measure': 'Inflammatory markers will be assessed at baseline (week 2), week 6, week 18 and'}, {'measure': 'week 26. Inflammatory markers to be analyzed are the following: C-reactive'}, {'measure': 'protein, amyloid A and interleukin 6.'}, {'measure': 'From the exercise tolerance tests the time to onset of 1 mm ST depression, time to'}, {'measure': 'onset of angina and total exercise time will be assessed at baseline (week 2),'}, {'measure': 'week 18 and week 26.'}]}, 'conditionsModule': {'conditions': ['Angina']}, 'referencesModule': {'references': [{'pmid': '20494902', 'type': 'DERIVED', 'citation': 'Deanfield JE, Sellier P, Thaulow E, Bultas J, Yunis C, Shi H, Buch J, Beckerman B. Potent anti-ischaemic effects of statins in chronic stable angina: incremental benefit beyond lipid lowering? Eur Heart J. 2010 Nov;31(21):2650-9. doi: 10.1093/eurheartj/ehq133. Epub 2010 May 21.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0531031&StudyName=Double+Blind+Atorvastatin+Amlodipine+Study+%28DUAAL+Study%29+', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "To evaluate and compare the safety and efficacy of amlodipine, atorvastatin and the combination in patients with symptomatic myocardial ischemia.\n\nAmlodipine's use in angina has been well documented in clinical trials such as the Circadian Anti-Ischemia Program in Europe (CAPE), but the impact on vascular inflammation in clinical practice has not been tested. Furthermore, the potentially synergistic benefit of atorvastatin and amlodipine on inflammation ischemic activity has not been studied."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Holter monitoring at baseline which demonstrates a total of 15 minutes of ischemia and/or 3 ischemic events per 48 hours.\n* Total cholesterol \\> 5.2 mmol/L (200 mg/dL) on diet alone.\n\nExclusion Criteria:\n\n* Myocardial infarction within 2 months prior to the study.\n* Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.'}, 'identificationModule': {'nctId': 'NCT00159718', 'acronym': 'DUAAL', 'briefTitle': 'Double Blind Atorvastatin Amlodipine Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Double Blind Atorvastatin Amlodipine Study (DUAAL) Effect Of Amlodipine, Atorvastatin And The Combination On Transient Myocardia Ischemia In Coronary Artery Disease.', 'orgStudyIdInfo': {'id': 'A0531031'}}, 'armsInterventionsModule': {'interventions': [{'name': 'amlodipine', 'type': 'DRUG'}, {'name': 'atorvastatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rijeka', 'country': 'Croatia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.32673, 'lon': 14.44241}}, {'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Ostrava-Kunčice', 'country': 'Czechia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.7903, 'lon': 18.2919}}, {'city': 'Pilsen', 'country': 'Czechia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Příbram', 'country': 'Czechia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.68988, 'lon': 14.01043}}, {'city': 'Rokycany', 'country': 'Czechia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.7427, 'lon': 13.59459}}, {'city': 'Tallinn', 'country': 'Estonia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Tartu', 'country': 'Estonia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'city': 'Debrecen', 'state': 'Budapest', 'country': 'Hungary', 'facility': 'Pfizer Investigational Site'}, {'city': 'Balatonfüred', 'country': 'Hungary', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 46.96188, 'lon': 17.87187}}, {'city': 'Berettyóújfalu', 'country': 'Hungary', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.22362, 'lon': 21.53656}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Zalaegerszeg', 'country': 'Hungary', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 46.83695, 'lon': 16.84401}}, {'city': 'Daugavpils', 'country': 'Latvia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 55.88333, 'lon': 26.53333}}, {'city': 'Riga', 'country': 'Latvia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'city': 'Valmiera', 'country': 'Latvia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 57.54108, 'lon': 25.42751}}, {'city': 'Baerum Postterminal', 'country': 'Norway', 'facility': 'Pfizer Investigational Site'}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Bytom', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.34802, 'lon': 18.93282}}, {'city': 'Katowice', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Brasov', 'state': 'Jud. 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