Ignite Creation Date:
2025-12-24 @ 1:07 PM
Ignite Modification Date:
2025-12-29 @ 7:22 PM
Study NCT ID:
NCT00332761
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2006-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caduet in an Untreated Subject Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C487936', 'term': 'amlodipine, atorvastatin drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2006-06-01', 'studyFirstSubmitQcDate': '2006-06-01', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-06-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 4.'}], 'secondaryOutcomes': [{'measure': 'The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 8.'}, {'measure': 'Change from Baseline to Week 4 in SBP, DBP, and Framingham 10-year CHD risk score.'}, {'measure': 'Percent change from Baseline to Week 4 in LDL-C, HDL, TC, and TG.'}, {'measure': 'The percentage of study subjects achieving each of the following goals at Week 4: SBP, DBP, and LDL-C.'}, {'measure': 'Change from Baseline to Week 8 in SBP, DBP, and Framingham 10-year CHD risk score.'}, {'measure': 'Percent change from Baseline to Week 8 in LDL-C, HDL, TC, and TG.'}, {'measure': 'The percentage of study subjects achieving each of SBP, DBP, and LDL-C goals at Week 8.'}]}, 'conditionsModule': {'conditions': ['Hypertension', 'Dyslipidemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3841046&StudyName=Caduet%20in%20an%20Untreated%20Subject%20Population.', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if Caduet will lower blood pressure to \\<140/90 mmHg and lower LDL Cholesterol to \\<100 mg/dL in subjects with hypertension and dyslipidemia who are not currently being treated for these medical conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who were recently diagnosed with both hypertension and dyslipidemia and who are not yet taking any medications for these conditions OR subjects with both hypertension and dyslipidemia who were previously treated with antihypertensive and/or lipid lowering medications but discontinued these medications for at least 3 months prior to the Screening visit.\n* SBP 140-169 mmHg and/or DBP 90-105 mmHg, LDL-C 110-160 mg/dL\n\nExclusion Criteria:\n\n* Subjects with a history of MI, angina, coronary artery bypass or intra-coronary interventions, stroke, TIA, CHF or cardiomyopathy requiring treatment.\n* Subjects with a known history of Type I or Type 2 Diabetes Mellitus or a fasting blood glucose \\> 126 mg/dL at the Screening visit.'}, 'identificationModule': {'nctId': 'NCT00332761', 'acronym': 'CUSP', 'briefTitle': 'Caduet in an Untreated Subject Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'An 8-Week Randomized, Double-Blind, Placebo-Controlled Trial Examining The Efficacy And Safety Of Caduet® In Simultaneously Achieving Blood Pressure And Lipid Goals In An Untreated Hypertensive And Dyslipidemic Subject Population. (CUSP - Caduet in Untreated Subject Population)', 'orgStudyIdInfo': {'id': 'A3841046'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Caduet', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72204', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92843', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92780', 'city': 'Tustin', 'state': 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