Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
Study NCT ID:
NCT00687206
Status:
COMPLETED
Last Update Posted:
2009-01-29
First Post:
2008-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Valsartan Plus Hydrochlorothiazide in Patients With Slight Hypertension and Target Organ Damage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D020257', 'term': 'Ventricular Remodeling'}, {'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068756', 'term': 'Valsartan'}, {'id': 'D006400', 'term': 'Hematocrit'}], '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': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D018056', 'term': 'Hemorheology'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-28', 'studyFirstSubmitDate': '2008-05-19', 'studyFirstSubmitQcDate': '2008-05-29', 'lastUpdatePostDateStruct': {'date': '2009-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The aim of this study is to assess if an early and adequate therapy could bring to a better pressure control (even during physical activity) and a regression of organ damage assessed by bicycle stress test and mono-bidimensional echocardiography.', 'timeFrame': '3 and 6 months'}], 'secondaryOutcomes': [{'measure': 'Effects of Valsartan 160mg / HCT 25mg on metabolism and erectile function', 'timeFrame': '3 and 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hypertension', 'Ventricular Remodeling', 'Erectile Dysfunctions']}, 'descriptionModule': {'briefSummary': 'Patients with slight increase in blood pressure levels have an increased cardiovascular risk. In particular this has been demonstrated also in subjects with high-normal blood pressure in whom an exaggerated blood pressure increase, during exercise, and structural left ventricular abnormalities have been shown. On the other hand, the last American and European guidelines for management of hypertension recommend more aggressive treatment in young-middle aged subjects to achieve a better control of cardiovascular risk due to blood pressure increase. In agreement with these recommendations the investigators share the idea that a good blood pressure control should be achieved not only at rest, but also during psycho-physical stress conditions that frequently occur during daily life. On this basis, the investigators decided to evaluate the efficacy and tolerability of the association of valsartan and hydrochlorothiazide (160 an 25 mg daily, respectively) in patients with high-normal blood pressure and first degree arterial hypertension with evidence of organ damage.\n\nThe aim of this study is to assess if an early and adequate therapy could bring to a better pressure control (even during physical activity) and a regression of organ damage without interfering with metabolism and erectile function'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-65\n* Gender Males\n* High-normal blood pressure (130-139 mmHg or 85-89 mmHg)\n* First degree hypertension (140-159 mmHg or 90-99 mmHg)\n* Cardiac remodeling (left ventricular concentric hypertrophy\n\nExclusion Criteria:\n\n* Coronary artery disease\n* Secondary hypertension\n* Diabetes mellitus\n* Incapacity to perform ergometry test\n* Anemia (Hb \\< 12.5g/dL)\n* Cardiac valve disease\n* Arrhythmia'}, 'identificationModule': {'nctId': 'NCT00687206', 'briefTitle': 'Efficacy and Safety of Valsartan Plus Hydrochlorothiazide in Patients With Slight Hypertension and Target Organ Damage', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Efficacy and Safety of Valsartan 160 mg Plus Hydrochlorothiazide 25 mg Once a Day in Patients With Slight Hypertension and Target Organ Damage', 'orgStudyIdInfo': {'id': 'Val25/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Valsartan 160mg plus HCT 25mg']}], 'interventions': [{'name': 'Valsartan 160mg plus HCT 25mg', 'type': 'DRUG', 'otherNames': ['Corixil 160/25mg', 'Cotareg 160/25mg'], 'description': 'valsartan 160 mg once a day for 6 months plus hydrochlorothiazide 25 mg a tablet once a day for 6 months', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'facility': 'Department of internal medicine University Federico II', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'overallOfficials': [{'name': 'Serafino Fazio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federico II University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Serafino Fazio MD', 'oldOrganization': 'Federico II University'}}}}