Viewing Study NCT01415505

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Ignite Creation Date: 2025-12-25 @ 3:26 AM

Ignite Modification Date: 2025-12-26 @ 2:06 AM

Study NCT ID: NCT01415505

Status: COMPLETED

Last Update Posted: 2013-06-04

First Post: 2011-08-10

Is NOT Gene Therapy: False

Has Adverse Events: False

Brief Title: Combination of Nebivolol and Valsartan Given as Free Tablets for Stage 1 or Stage 2 Hypertension

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068577', 'term': 'Nebivolol'}, {'id': 'D000068756', 'term': 'Valsartan'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'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': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D049971', 'term': 'Thiazides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 812}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-31', 'studyFirstSubmitDate': '2011-08-10', 'studyFirstSubmitQcDate': '2011-08-11', 'lastUpdatePostDateStruct': {'date': '2013-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Event Recording', 'timeFrame': 'From Baseline to Week 53 (Visit 16)'}], 'secondaryOutcomes': [{'measure': 'Diastolic Blood Pressure (DBP).', 'timeFrame': 'From Baseline to Week 52 (Visit 15)'}, {'measure': 'Systolic Blood Pressure (SBP)', 'timeFrame': 'From Baseline to Week 52 (Visit 15)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stage 1', 'Stage 2', 'Hypertension', '1 year open label safety study'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '25492835', 'type': 'DERIVED', 'citation': 'Neutel JM, Giles TD, Punzi H, Weiss RJ, Li H, Finck A. Long-term safety of nebivolol and valsartan combination therapy in patients with hypertension: an open-label, single-arm, multicenter study. J Am Soc Hypertens. 2014 Dec;8(12):915-20. doi: 10.1016/j.jash.2014.09.017. Epub 2014 Sep 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of nebivolol and valsartan given as a free tablet combination in patient with stage 1 or stage 2 essential hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female outpatients of age 18 years or above\n* Patients diagnosed with stage 1 or stage 2 essential hypertension\n* Normal physical examination findings, electrocardiogram (ECG) results and chest x-ray; or abnormal findings judged by the Investigator to be not clinically significant\n\nExclusion Criteria:\n\n* Secondary hypertension or severe hypertension\n* Clinically significant cardiovascular disease or heart failure\n* A medical contraindication to discontinuing a current antihypertensive therapy\n* History of Type 1 diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT01415505', 'briefTitle': 'Combination of Nebivolol and Valsartan Given as Free Tablets for Stage 1 or Stage 2 Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A Multicenter, Open-Label, Single-Arm, Free Tablet Combination, Long-Term Study to Evaluate the Safety of Nebivolol in Combination With Valsartan in Patients With Stage 1 or Stage 2 Essential Hypertension', 'orgStudyIdInfo': {'id': 'NAC-MD-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Nebivolol and Valsartan free tablet combination', 'interventionNames': ['Drug: Nebivolol, Valsartan and Hydrochlorothiazide']}], 'interventions': [{'name': 'Nebivolol, Valsartan and Hydrochlorothiazide', 'type': 'DRUG', 'description': 'Nebivolol 5 mg (tablet), oral administration Nebivolol 10 mg (tablet), oral administration Nebivolol 20 mg (tablet), oral administration Valsartan 160 mg (tablet), oral administration Valsartan 320 mg (tablet), oral administration Hydrochlorothiazide 12.5 mg rescue medication (capsules), oral administration. Hydrochlorothiazide 25 mg rescue medication (capsules), oral administration', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 083', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36535', 'city': 'Foley', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 004', 'geoPoint': {'lat': 30.40659, 'lon': -87.6836}}, {'zip': '36542', 'city': 'Gulf Shores', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 038', 'geoPoint': {'lat': 30.24604, 'lon': -87.70082}}, {'zip': '35662', 'city': 'Muscle Shoals', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 124', 'geoPoint': {'lat': 34.74481, 'lon': -87.66753}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Forest Investigative Site 023', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85395', 'city': 'Goodyear', 'state': 'Arizona', 'country': 'United States', 'facility': 'Forest Investigative Site 073', 'geoPoint': {'lat': 33.43532, 'lon': -112.35821}}, {'zip': '85614', 'city': 'Green Valley', 'state': 'Arizona', 'country': 'United States', 'facility': 'Forest Investigative Site 100', 'geoPoint': {'lat': 31.85425, 'lon': -110.9937}}, {'zip': '85203', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Forest Investigative Site 117', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85213', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Forest Investigative Site 065', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Forest Investigative Site 102', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85282', 'city': 'Tempe', 'state': 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