Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT00128518
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2005-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IDEAL Study: Identification of the Determinants of the Efficacy of Arterial Blood Pressure Lowering Drugs
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': 'D007190', 'term': 'Indapamide'}, {'id': 'D020913', 'term': 'Perindopril'}, {'id': 'C020845', 'term': 'P-2'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-13', 'studyFirstSubmitDate': '2005-08-09', 'studyFirstSubmitQcDate': '2005-08-09', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure at the end of each 4 week treatment period', 'timeFrame': '16 weeks', 'description': 'Change from baseline and after each 4 week treatment period'}]}, 'conditionsModule': {'keywords': ['Hypertension - Drugs - Blood pressure response - Responders - pharmacogenetics'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '24739801', 'type': 'RESULT', 'citation': 'Gueyffier F, Subtil F, Bejan-Angoulvant T, Zerbib Y, Baguet JP, Boivin JM, Mercier A, Leftheriotis G, Gagnol JP, Fauvel JP, Giraud C, Bricca G, Maucort-Boulch D, Erpeldinger S; IDEAL Trial Group. Can we identify response markers to antihypertensive drugs? First results from the IDEAL Trial. J Hum Hypertens. 2015 Jan;29(1):22-7. doi: 10.1038/jhh.2014.29. Epub 2014 Apr 17.'}]}, 'descriptionModule': {'briefSummary': 'The principal scientific objective of the trial is to identify the factors that are associated with differential blood pressure responses between drugs. This may allow investigators to produce new hypotheses on the pathophysiology of hypertension and on the mechanisms of drug action.\n\nThese factors can be of different types:\n\n* Environmental factors (sodium or alcohol intake);\n* Morphological (height, weight, body mass index, body surface area);\n* Initial blood pressure;\n* Electrocardiogram (ECG) parameters of left ventricular hypertrophy;\n* Biological parameters as the activity level of the renin angiotensin aldosterone system;\n* Genetic polymorphisms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants have to be 25 to 60 years of age\n* Both genders\n* Systolic blood pressure of 140 mmHg or above; diastolic blood pressure of 90 mmHg or above.\n* Cardiovascular risk must not be high, to allow for two periods of 4 weeks of placebo without ethical concern.'}, 'identificationModule': {'nctId': 'NCT00128518', 'briefTitle': 'IDEAL Study: Identification of the Determinants of the Efficacy of Arterial Blood Pressure Lowering Drugs', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'IDEAL Study : Identification of the Determinants of the Efficacy of Arterial Blood Pressure Lowering Drugs', 'orgStudyIdInfo': {'id': '2003.340'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A : T1+P2 ● P1+P2 ● T2+P1 ● P1+P2', 'description': 'T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2', 'interventionNames': ['Drug: Indapamide (T2)', 'Drug: Perindopril (T1)', 'Drug: Placebo of Perindopril (P1)', 'Drug: Placebo of Indapamide (P2)']}, {'type': 'EXPERIMENTAL', 'label': 'Group B : P1+P2 ● T1+P2 ● P1+P2 ● T2+P1', 'description': 'T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2', 'interventionNames': ['Drug: Indapamide (T2)', 'Drug: Perindopril (T1)', 'Drug: Placebo of Perindopril (P1)', 'Drug: Placebo of Indapamide (P2)']}, {'type': 'EXPERIMENTAL', 'label': 'Group C : T2+P1 ● P1+P2 ● T1+P2 ● P1+P2', 'description': 'T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2', 'interventionNames': ['Drug: Indapamide (T2)', 'Drug: Perindopril (T1)', 'Drug: Placebo of Perindopril (P1)', 'Drug: Placebo of Indapamide (P2)']}, {'type': 'EXPERIMENTAL', 'label': 'Group D : P1+P2 ● T2+P1 ● P1+P2 ● T1+P2', 'description': 'T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2', 'interventionNames': ['Drug: Indapamide (T2)', 'Drug: Perindopril (T1)', 'Drug: Placebo of Perindopril (P1)', 'Drug: Placebo of Indapamide (P2)']}], 'interventions': [{'name': 'Indapamide (T2)', 'type': 'DRUG', 'description': '1.5 mg/day during 4 weeks', 'armGroupLabels': ['Group A : T1+P2 ● P1+P2 ● T2+P1 ● P1+P2', 'Group B : P1+P2 ● T1+P2 ● P1+P2 ● T2+P1', 'Group C : T2+P1 ● P1+P2 ● T1+P2 ● P1+P2', 'Group D : P1+P2 ● T2+P1 ● P1+P2 ● T1+P2']}, {'name': 'Perindopril (T1)', 'type': 'DRUG', 'description': '4 mg/day during 1 week then 8 mg/day during 3 weeks', 'armGroupLabels': ['Group A : T1+P2 ● P1+P2 ● T2+P1 ● P1+P2', 'Group B : P1+P2 ● T1+P2 ● P1+P2 ● T2+P1', 'Group C : T2+P1 ● P1+P2 ● T1+P2 ● P1+P2', 'Group D : P1+P2 ● T2+P1 ● P1+P2 ● T1+P2']}, {'name': 'Placebo of Perindopril (P1)', 'type': 'DRUG', 'description': '1 pill/day during 1 week then 2 pills/day during 3 weeks', 'armGroupLabels': ['Group A : T1+P2 ● P1+P2 ● T2+P1 ● P1+P2', 'Group B : P1+P2 ● T1+P2 ● P1+P2 ● T2+P1', 'Group C : T2+P1 ● P1+P2 ● T1+P2 ● P1+P2', 'Group D : P1+P2 ● T2+P1 ● P1+P2 ● T1+P2']}, {'name': 'Placebo of Indapamide (P2)', 'type': 'DRUG', 'description': '1 pill/day during 4 weeks', 'armGroupLabels': ['Group A : T1+P2 ● P1+P2 ● T2+P1 ● P1+P2', 'Group B : P1+P2 ● T1+P2 ● P1+P2 ● T2+P1', 'Group C : T2+P1 ● P1+P2 ● T1+P2 ● P1+P2', 'Group D : P1+P2 ● T2+P1 ● P1+P2 ● T1+P2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Hôpital Louis Pradel', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'overallOfficials': [{'name': 'Francois GUEYFFIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}