Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT00933920
Status:
COMPLETED
Last Update Posted:
2020-12-21
First Post:
2009-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Light Meal on Pharmacokinetic and Pharmacodynamics of Aliskiren in Patients With Mild to Moderate Hypertension
Sponsor:
Organization:
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': 'C446481', 'term': 'aliskiren'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'lastUpdateSubmitDate': '2020-12-17', 'studyFirstSubmitDate': '2009-07-03', 'studyFirstSubmitQcDate': '2009-07-06', 'lastUpdatePostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare PK (AUC & Cmax) and PD, i.e. PRA (Plasma Renin Activity, AUE) of aliskiren when given with and without light meal.', 'timeFrame': '28 Days'}], 'secondaryOutcomes': [{'measure': 'Compare the effect of Plasma Renin Concentration (PRC) and angiotensin II of aliskiren when given with and without light meal', 'timeFrame': '28 Days'}, {'measure': 'Assess safety and tolerability of aliskiren when given with and without light meal', 'timeFrame': '28 days'}, {'measure': 'Evaluate the effect on mean sitting systolic and diastolic blood pressure of aliskiren when given with or without a light meal', 'timeFrame': '28 days'}]}, 'conditionsModule': {'keywords': ['Aliskiren,', 'hypertension,', 'renin-angiotensin-aldosterone system,', 'pharmacokinetics,', 'pharmacodynamics'], 'conditions': ['Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=3763', 'label': 'Results for CSPP100A2110 can be found on the Novartis Clinical Trial Results Website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of a light meal on the pharmacokinetics and pharmacodynamics of aliskiren in patients with mild to moderate hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female outpatients, 18 to 65 years of age with mild to moderate hypertension\n* Patients who are eligible and able to participate in the study\n\nExclusion criteria:\n\n* Severe hypertension\n* Secondary form of hypertension.\n* Type 1 or type 2 diabetes mellitus\n* Serum potassium out side laboratory reference range\n* Any history of hypertensive encephalopathy or cerebrovascular accident\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00933920', 'briefTitle': 'Effect of Light Meal on Pharmacokinetic and Pharmacodynamics of Aliskiren in Patients With Mild to Moderate Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Single-blind, Parallel Group, Multiple Oral Dose Study to Evaluate the Effect of a Light Meal on the Pharmacokinetics and Pharmacodynamics of Aliskiren Using Market 300 mg Tablet Formulation in Subjects With Mild to Moderate Hypertension', 'orgStudyIdInfo': {'id': 'CSPP100A2110'}, 'secondaryIdInfos': [{'id': 'CTRI/2009/091/000287'}, {'id': '26-06-2009'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fed Group', 'interventionNames': ['Drug: Aliskiren']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fasted group', 'interventionNames': ['Drug: Aliskiren']}], 'interventions': [{'name': 'Aliskiren', 'type': 'DRUG', 'armGroupLabels': ['Fed Group']}, {'name': 'Aliskiren', 'type': 'DRUG', 'armGroupLabels': ['Fasted group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Coimbatore', 'country': 'India', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 11.00555, 'lon': 76.96612}}, {'city': 'Hyderabaad', 'country': 'India', 'facility': 'Novartis Investigative Site'}, {'city': 'Hyderabaad', 'country': 'India', 'facility': 'Novartis Investigator Site'}, {'city': 'Mangalore', 'country': 'India', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 12.91723, 'lon': 74.85603}}, {'city': 'New Delhi', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis Pharmaceuticals'}}}}