Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-31 @ 10:50 AM
Study NCT ID:
NCT01429233
Status:
UNKNOWN
Last Update Posted:
2011-09-07
First Post:
2011-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real Life Experience of the Use of Isomers as ALENCAL (Levamlodipine) for Evaluation of Efficacy, Safety and Tolerability in the Management of Cardiovascular Disease in Colombian Patients
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-09-06', 'studyFirstSubmitDate': '2011-08-29', 'studyFirstSubmitQcDate': '2011-09-06', 'lastUpdatePostDateStruct': {'date': '2011-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of therapy in the management of hypertension and other cardiovascular diseases', 'timeFrame': '8 weeks', 'description': 'The change from Baseline in Blood Pressure at 8 weeks will be measure to evaluate th efficacy of the therapy.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '8 weeks', 'description': 'The number of Participants with Serious and Non- seriuous Adverse Events wil be mesure to evaluate the tolerability and safety profile in 8 weeks follow up.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Observational', 'Colombia'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This is a Phase 4, observational, open study in patients whom their doctor for clinical practice prescribes levamlodipine. No medication was provided by the sponsor. The planned observation time is 8 weeks. The 8 weeks of observation involves an evaluation of baseline followed by information gathered from the assessment visits at week 4 and week 8, or clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care adults in Colombia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients whose primary physician based on their clinical condition and locally approved use will be eligible to participate in this study, and have been prescribe with Levamlodipine.'}, 'identificationModule': {'nctId': 'NCT01429233', 'acronym': 'XPRES', 'briefTitle': 'Real Life Experience of the Use of Isomers as ALENCAL (Levamlodipine) for Evaluation of Efficacy, Safety and Tolerability in the Management of Cardiovascular Disease in Colombian Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Closter Pharma'}, 'officialTitle': 'Real Life Experience of the Use of Isomers as ALENCAL(Levoamlodipine) for Evaluation of Efficacy, Safety and Tolerability in the Management of Cardiovascular Disease in Colombian Patients', 'orgStudyIdInfo': {'id': 'COL-CARDIO-NIS001'}}, 'contactsLocationsModule': {'locations': [{'city': 'Bogotá', 'status': 'RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Andres Romero, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Country Club Bogota', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}], 'centralContacts': [{'name': 'Sandra M Casiano, M.D.', 'role': 'CONTACT', 'email': 'scasiano@closterpharma.com', 'phone': '57-3174049763'}, {'name': 'Harold Mejia', 'role': 'CONTACT', 'email': 'hmejia@closterpharma.com', 'phone': '57-2264757'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Closter Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}