Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-04 @ 10:42 PM
Study NCT ID:
NCT02662894
Status:
WITHDRAWN
Last Update Posted:
2021-02-24
First Post:
2015-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia.
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': 'D000068756', 'term': 'Valsartan'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014633', 'term': 'Valine'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2015-11-23', 'studyFirstSubmitQcDate': '2016-01-21', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of systemic blood pressure measured between the first visit and last visit.', 'timeFrame': '8 weeks'}, {'measure': 'Percentage of participants who reach the goal of LDL-C according to intermediate risk rating ( LDLc < 100mg / dL ) and high risk ( LDLc < 70 mg / dL ) .', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Incidence and severity of adverse events recorded after the signing of the Informed Consent ( IC) and until the end of the study.', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'Noninferiority trial to assess efficacy of fixed-dose combination of valsartan + rosuvastatin versus their isolated components in treatment of hypertension and dyslipidemia.', 'detailedDescription': '* Open-label,randomized, multicenter;\n* Maximal experiment duration: 8 weeks;\n* 04 visits;\n* Safety and efficacy evaluation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants of both sexes aged between 18 and 65 years;\n* Participants diagnosed with uncontrolled hypertension;\n* Participants with intermediate and high risk dyslipidemia, according to the V Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;\n* Ability to understand and consent to participate in this clinical study, manifested by signing the Informed Consent and Informed ( IC) .\n\nExclusion Criteria:\n\n* Participants with a previous diagnosis of familial hypercholesterolemia (homozygous);\n* Concomitant use of angiotensin II receptor blocker (ARB) or inhibitor of angiotensin converting enzyme (ACE);\n* participants with isolated hypertriglyceridemia (TG ≥150 mg / dL) according to V Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;\n* research participants with total cholesterol (TC) above 500 mg / dL or triglyceride (TG) above 400 mg / dL;\n* participants with systolic blood pressure ≥180 mmHg or diastolic ≥110 mmHg;\n* research participants with postural hypotension (SBP decrease ≥20 mmHg or DBP ≥10 mmHg in orthostatic position in relation to the sitting position);\n* History of congestive heart failure (CHF) functional class III or IV (NYHA);;\n* any clinical, laboratory and electrocardiographic that, in the judgment of the investigator, may interfere with the safety of research participants;\n* Creatine phosphokinase (CPK) levels above the established laboratory normal range;\n* Transaminases (ALT and ASL) serum above 2 times the established laboratory normal range;\n* Body mass index (BMI) ≥35 kg / m²;\n* Immunocompromised participants (eg .: malignancies, patients with Acquired Immunodeficiency Syndrome etc);\n* Chronic use of drugs that may interact with the drugs of the study;\n* Patients on concomitant lipid-lowering therapy;\n* History hypersensitivity to the active ingredients used in the study;\n* Participants who are pregnant, nursing or planning to become pregnant, or female participants of childbearing potential who are not using a reliable method of contraception;\n* History of alcohol abuse or illicit drug use;\n* Adherence to uniformization medication \\<80%;\n* Participating in the research that has participated in clinical trial protocols in the last twelve (12) months (CNS Resolution 251 of August 7, 1997, Part III, sub-item J), unless the investigator considers that there may be direct benefit to it;'}, 'identificationModule': {'nctId': 'NCT02662894', 'briefTitle': 'Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia.', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMS'}, 'officialTitle': 'Efficacy of Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia.', 'orgStudyIdInfo': {'id': 'EMS0815'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Valsartan 160mg + Rosuvastatin 20mg', 'description': 'Fixed-dose combination of valsartan (160mg) + rosuvastatin (20 mg), oral, once daily.', 'interventionNames': ['Drug: Valsartan 160mg + Rosuvastatin 20mg']}, {'type': 'EXPERIMENTAL', 'label': 'Valsartan 320mg + Rosuvastatin 20mg', 'description': 'Fixed-dose combination of valsartan (320 mg) + rosuvastatin (20 mg), oral, once daily.', 'interventionNames': ['Drug: Valsartan 320mg + Rosuvastatin 20mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diovan® 160mg + Crestor® 20mg', 'description': 'Take together 1 tablet of Diovan (160mg) plus 1 tablet of Crestor (20mg), oral, once daily.', 'interventionNames': ['Drug: Diovan® 160mg + Crestor® 20mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diovan® 320mg + Crestor® 20mg', 'description': 'Take together 1 tablet of Diovan (320mg) plus 1 tablet of Crestor (20mg), oral, once daily.', 'interventionNames': ['Drug: Diovan® 320mg + Crestor® 20mg']}], 'interventions': [{'name': 'Valsartan 160mg + Rosuvastatin 20mg', 'type': 'DRUG', 'description': '1 tablet, oral, a day', 'armGroupLabels': ['Valsartan 160mg + Rosuvastatin 20mg']}, {'name': 'Valsartan 320mg + Rosuvastatin 20mg', 'type': 'DRUG', 'description': '1 tablet, oral, a day', 'armGroupLabels': ['Valsartan 320mg + Rosuvastatin 20mg']}, {'name': 'Diovan® 160mg + Crestor® 20mg', 'type': 'DRUG', 'otherNames': ['Valsartan 160mg + Rosuvastatin 20mg'], 'description': 'Take together 1 tablet of Diovan (160mg) plus 1 tablet of Crestor (20mg), oral, once daily.', 'armGroupLabels': ['Diovan® 160mg + Crestor® 20mg']}, {'name': 'Diovan® 320mg + Crestor® 20mg', 'type': 'DRUG', 'otherNames': ['Valsartan 320mg + Rosuvastatin 20mg'], 'description': 'Take together 1 tablet of Diovan (320mg) plus 1 tablet of Crestor (20mg), oral, once daily.', 'armGroupLabels': ['Diovan® 320mg + Crestor® 20mg']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}