Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-02-20 @ 11:50 PM
Study NCT ID:
NCT00716950
Status:
UNKNOWN
Last Update Posted:
2008-07-17
First Post:
2008-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Valsartan and Amlodipine Compared to Losartan and Amlodipine in Hypertensive Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068756', 'term': 'Valsartan'}, {'id': 'D019808', 'term': 'Losartan'}], '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': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 187}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2009-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-07-16', 'studyFirstSubmitDate': '2008-07-14', 'studyFirstSubmitQcDate': '2008-07-14', 'lastUpdatePostDateStruct': {'date': '2008-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24 hours mean, determinated through ABPM; diastolic mean after 4 weeks of losartan 100mg/amlodipine 5mg and valsartan 160mg/amlodipine 5mg treatment', 'timeFrame': 'after 4 weeks'}], 'secondaryOutcomes': [{'measure': '24 hours systolic mean, determinated through ABPM; day systolic and diastolic mean determinated through ABPM; night systolic and diastolic mean determinated through ABPM', 'timeFrame': 'after 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Essential Hypertension']}, 'descriptionModule': {'briefSummary': 'Hypertensive patients with moderate hypertension have a risk to develop cardiovascular events of 15-20% over a period of 10 years. It is important to reach quickly the advised target, but often this result can be obtained with a combination therapy. Some evidences demonstrate sartans and calcium channels blockers can be very useful and safe, but it is also important to verify which association can give side effects or give some pharmacokinetic interactions that can negatively influence the clinical combination efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diastolic blood pressure in sitting position 100 to 109 mmHg and systolic blood pressure \\> 140 mmHg at the end of the selection period\n\nExclusion Criteria:\n\n* type 2 diabetes mellitus\n* heart failure\n* AMI in the previous 6 months\n* angina pectoris\n* secondary hypertension\n* malignant hypertension\n* women child-bearing potential\n* women who are pregnant and lactating\n* suspected history of allergy to the sartans or calcium channels blockers'}, 'identificationModule': {'nctId': 'NCT00716950', 'briefTitle': 'Valsartan and Amlodipine Compared to Losartan and Amlodipine in Hypertensive Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Pavia'}, 'officialTitle': 'Evaluation of Antihypertensive Activity of Valsartan and Amlodipine Compared to Losartan and Amlodipine Through Ambulatory Blood Pressure Monitoring in Moderate Hypertensive Patients in a Randomized, Controlled, Double-Blind Study', 'orgStudyIdInfo': {'id': 'UNIPV004DIM2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'valsartan/amlodipine', 'interventionNames': ['Drug: valsartan/amlodpine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'losartan/amlodpine', 'interventionNames': ['Drug: losartan/amlodpine']}], 'interventions': [{'name': 'valsartan/amlodpine', 'type': 'DRUG', 'description': 'tablets; 160mg/5mg; od; 4 weeks', 'armGroupLabels': ['1']}, {'name': 'losartan/amlodpine', 'type': 'DRUG', 'description': 'tablets; 100mg/5mg; od; 4 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Derosa, MD', 'role': 'CONTACT', 'email': 'giuseppe.derosa@unipv.it', 'phone': '+39 0382 502614'}, {'name': 'Giuseppe Derosa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Giuseppe Derosa', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'centralContacts': [{'name': 'Roberto Fogari, MD', 'role': 'CONTACT', 'email': 'r.fogari@unipv.it', 'phone': '+39 0382 526217'}], 'overallOfficials': [{'name': 'Roberto Fogari, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Pavia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pavia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Roberto Fogari/Full Professor of Internal Medicine', 'oldOrganization': 'University of Pavia'}}}}