Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT01176032
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
2010-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}, {'id': 'D019808', 'term': 'Losartan'}, {'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}], 'ancestors': [{'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'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialandresults.registries@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks', 'otherNumAtRisk': 37, 'otherNumAffected': 12, 'seriousNumAtRisk': 37, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Losartan', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks', 'otherNumAtRisk': 37, 'otherNumAffected': 16, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks'}, {'id': 'OG001', 'title': 'Lostaran', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.22', 'spread': '20.37', 'groupId': 'OG000'}, {'value': '-4.25', 'spread': '24.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 36', 'description': 'PICP is a measure of blood concentration of procollagen I carboxy-terminal propeptide (PICP), a peptide released from the myocardium when procollagen is converted to type I collagen. This biomarker exhibits good specificity and sensitivity for identifying myocardial fibrosis in hypertension.', 'unitOfMeasure': 'ug/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Biomarkers in Heart Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks'}, {'id': 'OG001', 'title': 'Lostaran', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks'}], 'classes': [{'title': 'cardiotrophin-1 (CT-1) (n=32,37)', 'categories': [{'measurements': [{'value': '-169.15', 'spread': '561.51', 'groupId': 'OG000'}, {'value': '-128.23', 'spread': '568.02', 'groupId': 'OG001'}]}]}, {'title': 'matrix metalloproteinase-1 (MMP-1) (n=32,37)', 'categories': [{'measurements': [{'value': '5.93', 'spread': '13.33', 'groupId': 'OG000'}, {'value': '5.51', 'spread': '9.58', 'groupId': 'OG001'}]}]}, {'title': 'tissue inhibitor of MMPs (TIMP-1) (n=32,37)', 'categories': [{'measurements': [{'value': '-0.70', 'spread': '59.18', 'groupId': 'OG000'}, {'value': '9.15', 'spread': '42.58', 'groupId': 'OG001'}]}]}, {'title': 'annexin A5 (AnxA5) (n=31,37)', 'categories': [{'measurements': [{'value': '-0.98', 'spread': '7.33', 'groupId': 'OG000'}, {'value': '-1.21', 'spread': '4.75', 'groupId': 'OG001'}]}]}, {'title': 'NT-proBNP (n=31,34)', 'categories': [{'measurements': [{'value': '18.66', 'spread': '165.21', 'groupId': 'OG000'}, {'value': '-7.55', 'spread': '38.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 36', 'description': 'The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP)', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks'}, {'id': 'OG001', 'title': 'Lostaran', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.81', 'spread': '27.78', 'groupId': 'OG000'}, {'value': '-7.90', 'spread': '76.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 36', 'description': 'The plasma level of biomarker parameter (aldosterone (Aldo)) used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI)', 'unitOfMeasure': 'ng/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule", 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks'}, {'id': 'OG001', 'title': 'Lostaran', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks'}], 'classes': [{'title': 'LV end-diastolic volume (n=22,34)', 'categories': [{'measurements': [{'value': '2.30', 'spread': '35.65', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '33.19', 'groupId': 'OG001'}]}]}, {'title': 'LV end-systolic volume (n=22,34)', 'categories': [{'measurements': [{'value': '-0.92', 'spread': '12.24', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '21.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 36', 'description': "Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule", 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks'}, {'id': 'OG001', 'title': 'Lostaran', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks'}], 'classes': [{'title': 'LV ejection fraction Teicholz(n=29,36)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'LV ejection fraction Simpson(n=22,34)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 36', 'description': 'Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson)', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks'}, {'id': 'OG001', 'title': 'Lostaran', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.13', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.98', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 36', 'description': 'Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter', 'unitOfMeasure': 'mm/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks'}, {'id': 'OG001', 'title': 'Lostaran', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.55', 'spread': '17.94', 'groupId': 'OG000'}, {'value': '-2.27', 'spread': '26.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 36', 'description': "Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method)", 'unitOfMeasure': 'cm3/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Reduction of Left Ventricular Mass Index (LVMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks'}, {'id': 'OG001', 'title': 'Lostaran', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.05', 'spread': '18.98', 'groupId': 'OG000'}, {'value': '-7.96', 'spread': '18.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 36', 'description': 'Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI', 'unitOfMeasure': 'g/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks'}, {'id': 'OG001', 'title': 'Aliskiren + Amlodipine', 'description': '5 mg of amlodipine in addition to the study medication in order to reach the required BP (\\<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (\\<140/90 mmHg) was still not achieved.'}, {'id': 'OG002', 'title': 'Losartan', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks'}, {'id': 'OG003', 'title': 'Losartan + Amlodipine', 'description': '5 mg of amlodipine in addition to the study medication in order to reach the required BP (\\<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (\\<140/90 mmHg) was still not achieved.'}], 'classes': [{'title': 'CT-1(n=15,17,16,21)', 'categories': [{'measurements': [{'value': '-289.18', 'spread': '608.91', 'groupId': 'OG000'}, {'value': '-63.23', 'spread': '510.91', 'groupId': 'OG001'}, {'value': '156.89', 'spread': '599.29', 'groupId': 'OG002'}, {'value': '-345.47', 'spread': '443.63', 'groupId': 'OG003'}]}]}, {'title': 'ANXA5 (n=15,16,16,21)', 'categories': [{'measurements': [{'value': '-1.24', 'spread': '3.70', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '9.73', 'groupId': 'OG001'}, {'value': '-1.73', 'spread': '4.21', 'groupId': 'OG002'}, {'value': '-0.81', 'spread': '5.20', 'groupId': 'OG003'}]}]}, {'title': 'MMP-1(n=15,17,16,21)', 'categories': [{'measurements': [{'value': '7.00', 'spread': '10.28', 'groupId': 'OG000'}, {'value': '4.99', 'spread': '15.80', 'groupId': 'OG001'}, {'value': '5.47', 'spread': '7.88', 'groupId': 'OG002'}, {'value': '5.54', 'spread': '10.89', 'groupId': 'OG003'}]}]}, {'title': 'TIMP-1 (n=15,17,16,21)', 'categories': [{'measurements': [{'value': '-10.01', 'spread': '73.00', 'groupId': 'OG000'}, {'value': '7.51', 'spread': '44.38', 'groupId': 'OG001'}, {'value': '21.38', 'spread': '38.40', 'groupId': 'OG002'}, {'value': '-0.16', 'spread': '44.13', 'groupId': 'OG003'}]}]}, {'title': 'NT-proBNP (n=15,16,15,19)', 'categories': [{'measurements': [{'value': '21.00', 'spread': '214.06', 'groupId': 'OG000'}, {'value': '16.46', 'spread': '108.69', 'groupId': 'OG001'}, {'value': '-3.68', 'spread': '23.78', 'groupId': 'OG002'}, {'value': '-10.60', 'spread': '46.91', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 36', 'description': 'The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP)', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease in Combination of Aliskiren With Amlodipine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks'}, {'id': 'OG001', 'title': 'Aliskiren + Amlodipine', 'description': '5 mg of amlodipine in addition to the study medication in order to reach the required BP (\\<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (\\<140/90 mmHg) was still not achieved.'}, {'id': 'OG002', 'title': 'Losartan', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks'}, {'id': 'OG003', 'title': 'Losartan + Amlodipine', 'description': '5 mg of amlodipine in addition to the study medication in order to reach the required BP (\\<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (\\<140/90 mmHg) was still not achieved.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.81', 'spread': '21.36', 'groupId': 'OG000'}, {'value': '-5.89', 'spread': '32.54', 'groupId': 'OG001'}, {'value': '-3.12', 'spread': '32.45', 'groupId': 'OG002'}, {'value': '-11.55', 'spread': '98.35', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 36', 'description': 'The plasma level of biomarker parameter plasma aldosterone used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI).', 'unitOfMeasure': 'ng/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule in Combination of Aliskiren With Amlodipine", 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks'}, {'id': 'OG001', 'title': 'Aliskiren + Amlodipinet', 'description': '5 mg of amlodipine in addition to the study medication in order to reach the required BP (\\<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (\\<140/90 mmHg) was still not achieved.'}, {'id': 'OG002', 'title': 'Losartan', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks'}, {'id': 'OG003', 'title': 'Losartan + Amlodipine', 'description': '5 mg of amlodipine in addition to the study medication in order to reach the required BP (\\<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (\\<140/90 mmHg) was still not achieved.'}], 'classes': [{'title': 'LV end-diastolic volume (n=11,11,15,19)', 'categories': [{'measurements': [{'value': '6.60', 'spread': '40.43', 'groupId': 'OG000'}, {'value': '-2.00', 'spread': '31.51', 'groupId': 'OG001'}, {'value': '5.01', 'spread': '38.15', 'groupId': 'OG002'}, {'value': '-2.98', 'spread': '29.30', 'groupId': 'OG003'}]}]}, {'title': 'LV end-systolic volume (n=11,11, 15,19)', 'categories': [{'measurements': [{'value': '-2.93', 'spread': '13.24', 'groupId': 'OG000'}, {'value': '1.09', 'spread': '11.44', 'groupId': 'OG001'}, {'value': '6.11', 'spread': '23.82', 'groupId': 'OG002'}, {'value': '-3.69', 'spread': '17.97', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 36', 'description': "Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule", 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks'}, {'id': 'OG001', 'title': 'Aliskiren + Amlodipinet', 'description': '5 mg of amlodipine in addition to the study medication in order to reach the required BP (\\<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (\\<140/90 mmHg) was still not achieved.'}, {'id': 'OG002', 'title': 'Losartan', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks'}, {'id': 'OG003', 'title': 'Losartan + Amlodipine', 'description': '5 mg of amlodipine in addition to the study medication in order to reach the required BP (\\<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (\\<140/90 mmHg) was still not achieved.'}], 'classes': [{'title': 'LV ejection fraction Teicholz (n=14,15,16,20)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '-0.00', 'spread': '0.07', 'groupId': 'OG002'}, {'value': '0.01', 'spread': '0.09', 'groupId': 'OG003'}]}]}, {'title': 'LV ejection fraction Simpson(n=11,11,15,19)', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '0.12', 'groupId': 'OG002'}, {'value': '0.02', 'spread': '0.11', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 36', 'description': 'Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson)', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter in Combination of Aliskiren With Amlodipine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks'}, {'id': 'OG001', 'title': 'Aliskiren + Amlodipinet', 'description': '5 mg of amlodipine in addition to the study medication in order to reach the required BP (\\<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (\\<140/90 mmHg) was still not achieved.'}, {'id': 'OG002', 'title': 'Losartan', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks'}, {'id': 'OG003', 'title': 'Losartan + Amlodipine', 'description': '5 mg of amlodipine in addition to the study medication in order to reach the required BP (\\<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (\\<140/90 mmHg) was still not achieved.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.18', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '-0.19', 'spread': '0.96', 'groupId': 'OG002'}, {'value': '-0.24', 'spread': '1.03', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 36', 'description': 'Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter', 'unitOfMeasure': 'mm/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) in Combination of Aliskiren With Amlodipine", 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks'}, {'id': 'OG001', 'title': 'Aliskiren + Amlodipinet', 'description': '5 mg of amlodipine in addition to the study medication in order to reach the required BP (\\<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (\\<140/90 mmHg) was still not achieved.'}, {'id': 'OG002', 'title': 'Losartan', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks'}, {'id': 'OG003', 'title': 'Losartan + Amlodipine', 'description': '5 mg of amlodipine in addition to the study medication in order to reach the required BP (\\<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (\\<140/90 mmHg) was still not achieved.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.88', 'spread': '15.74', 'groupId': 'OG000'}, {'value': '7.78', 'spread': '17.14', 'groupId': 'OG001'}, {'value': '-7.42', 'spread': '24.37', 'groupId': 'OG002'}, {'value': '1.30', 'spread': '28.21', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 36', 'description': "Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method)", 'unitOfMeasure': 'cm3/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of LVMI in Combination of Aliskiren With Amlodipine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks'}, {'id': 'OG001', 'title': 'Aliskiren + Amlodipinet', 'description': '5 mg of amlodipine in addition to the study medication in order to reach the required BP (\\<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (\\<140/90 mmHg) was still not achieved.'}, {'id': 'OG002', 'title': 'Losartan', 'description': 'losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks'}, {'id': 'OG003', 'title': 'Losartan + Amlodipine', 'description': '5 mg of amlodipine in addition to the study medication in order to reach the required BP (\\<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (\\<140/90 mmHg) was still not achieved.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.68', 'spread': '18.95', 'groupId': 'OG000'}, {'value': '-10.26', 'spread': '19.40', 'groupId': 'OG001'}, {'value': '-3.59', 'spread': '13.46', 'groupId': 'OG002'}, {'value': '-11.46', 'spread': '21.71', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 36', 'description': 'Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI', 'unitOfMeasure': 'g/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment'}, {'type': 'SECONDARY', 'title': 'Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks'}, {'id': 'OG001', 'title': 'Lostaran', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks'}], 'classes': [{'title': 'Baseline, Week 10 (n=30,37)', 'categories': [{'measurements': [{'value': '-5.56', 'spread': '12.89', 'groupId': 'OG000'}, {'value': '-4.03', 'spread': '16.93', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Week 18 (n=29,36)', 'categories': [{'measurements': [{'value': '-9.77', 'spread': '12.25', 'groupId': 'OG000'}, {'value': '-8.44', 'spread': '17.30', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Week 26 (n=29,36)', 'categories': [{'measurements': [{'value': '-12.69', 'spread': '15.05', 'groupId': 'OG000'}, {'value': '-10.40', 'spread': '15.74', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Week 36 (n=32,37)', 'categories': [{'measurements': [{'value': '-8.87', 'spread': '19.26', 'groupId': 'OG000'}, {'value': '-8.88', 'spread': '15.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 10,18,26,36', 'description': 'The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment'}, {'type': 'SECONDARY', 'title': 'Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks'}, {'id': 'OG001', 'title': 'Lostaran', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks'}], 'classes': [{'title': 'Baseline, Week 10 (n=30,37)', 'categories': [{'measurements': [{'value': '-1.77', 'spread': '10.22', 'groupId': 'OG000'}, {'value': '-3.15', 'spread': '10.97', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Week 18 (n=29,36)', 'categories': [{'measurements': [{'value': '-5.34', 'spread': '10.66', 'groupId': 'OG000'}, {'value': '-7.07', 'spread': '9.98', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Week 26 (n=29,36)', 'categories': [{'measurements': [{'value': '-5.34', 'spread': '11.37', 'groupId': 'OG000'}, {'value': '-6.94', 'spread': '10.10', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Week 36 (n=32,37)', 'categories': [{'measurements': [{'value': '-4.19', 'spread': '10.32', 'groupId': 'OG000'}, {'value': '-6.68', 'spread': '9.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 10,18,26,36', 'description': 'The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment'}, {'type': 'SECONDARY', 'title': 'Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks'}, {'id': 'OG001', 'title': 'Lostaran', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks'}], 'classes': [{'title': 'Baseline, Week 10', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Week 18', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Week 26', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Week 36', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week10,18,26,36', 'description': 'Response rate was defined as the proportion of patients with a satisfactory systolic BP response (SBP \\< 140 mmHg or reduction of ≥ 10 mmHg compared to baseline) and a satisfactory diastolic BP response (DBP \\< 90 mmHg or reduction of ≥ 5 mmHg compared to baseline)', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment'}, {'type': 'SECONDARY', 'title': 'Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With SBP < 140 mmHg and DBP < 90 mmHg Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks'}, {'id': 'OG001', 'title': 'Lostaran', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks'}], 'classes': [{'title': 'Control rate at Week 10', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Control rate at Week 18', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Control rate at Week 26', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Control rate at Week 36', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week10,18,26,36', 'description': 'The control rate was defined as the proportion of patients with SBP \\< 140 mmHg and DBP \\< 90 mmHg compared to baseline', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment'}, {'type': 'SECONDARY', 'title': 'Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks'}, {'id': 'OG001', 'title': 'Lostaran', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks'}], 'classes': [{'title': 'Baseline, Week 10 (amlodipine)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Week 18 (amlodipine)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Week 26 (hydrochlorothiazide)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 10,18,26', 'description': 'The rate of use of first and second antihypertensive rescue drugs added was also assessed at all visits after week 2. The rescue drug at week 10 and 18 for those patients not achieving the required BP was amlodipine, Patients who did not achieve the required BP at week 26 were treated with hydrochlorothiazide', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks'}, {'id': 'FG001', 'title': 'Lostaran', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '"Started" indicates randomized and safety population', 'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'Intention-to-treat (ITT) Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Informed consent withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks'}, {'id': 'BG001', 'title': 'Lostaran', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.34', 'spread': '9.34', 'groupId': 'BG000'}, {'value': '58.05', 'spread': '10.34', 'groupId': 'BG001'}, {'value': '59.12', 'spread': '9.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intention-to-treat (ITT) population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-22', 'studyFirstSubmitDate': '2010-08-02', 'resultsFirstSubmitDate': '2014-04-22', 'studyFirstSubmitQcDate': '2010-08-03', 'lastUpdatePostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-22', 'studyFirstPostDateStruct': {'date': '2010-08-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP)', 'timeFrame': 'Baseline, Week 36', 'description': 'PICP is a measure of blood concentration of procollagen I carboxy-terminal propeptide (PICP), a peptide released from the myocardium when procollagen is converted to type I collagen. This biomarker exhibits good specificity and sensitivity for identifying myocardial fibrosis in hypertension.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Biomarkers in Heart Disease', 'timeFrame': 'Baseline, Week 36', 'description': 'The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP)'}, {'measure': 'Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease', 'timeFrame': 'Baseline, Week 36', 'description': 'The plasma level of biomarker parameter (aldosterone (Aldo)) used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI)'}, {'measure': "Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule", 'timeFrame': 'Baseline, Week 36', 'description': "Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule"}, {'measure': 'Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson)', 'timeFrame': 'Baseline, Week 36', 'description': 'Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson)'}, {'measure': 'Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter', 'timeFrame': 'Baseline, Week 36', 'description': 'Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter'}, {'measure': "Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method)", 'timeFrame': 'Baseline, Week 36', 'description': "Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method)"}, {'measure': 'Change From Baseline in Reduction of Left Ventricular Mass Index (LVMI)', 'timeFrame': 'Baseline, Week 36', 'description': 'Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI'}, {'measure': 'Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease.', 'timeFrame': 'Baseline, Week 36', 'description': 'The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP)'}, {'measure': 'Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease in Combination of Aliskiren With Amlodipine', 'timeFrame': 'Baseline, Week 36', 'description': 'The plasma level of biomarker parameter plasma aldosterone used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI).'}, {'measure': "Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule in Combination of Aliskiren With Amlodipine", 'timeFrame': 'Baseline, Week 36', 'description': "Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule"}, {'measure': 'Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine', 'timeFrame': 'Baseline, Week 36', 'description': 'Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson)'}, {'measure': 'Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter in Combination of Aliskiren With Amlodipine', 'timeFrame': 'Baseline, Week 36', 'description': 'Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter'}, {'measure': "Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) in Combination of Aliskiren With Amlodipine", 'timeFrame': 'Baseline, Week 36', 'description': "Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method)"}, {'measure': 'Change From Baseline of LVMI in Combination of Aliskiren With Amlodipine', 'timeFrame': 'Baseline, Week 36', 'description': 'Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI'}, {'measure': 'Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP)', 'timeFrame': 'Baseline, Week 10,18,26,36', 'description': 'The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values'}, {'measure': 'Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP)', 'timeFrame': 'Baseline, Week 10,18,26,36', 'description': 'The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values'}, {'measure': 'Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate', 'timeFrame': 'Baseline, Week10,18,26,36', 'description': 'Response rate was defined as the proportion of patients with a satisfactory systolic BP response (SBP \\< 140 mmHg or reduction of ≥ 10 mmHg compared to baseline) and a satisfactory diastolic BP response (DBP \\< 90 mmHg or reduction of ≥ 5 mmHg compared to baseline)'}, {'measure': 'Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With SBP < 140 mmHg and DBP < 90 mmHg Compared to Baseline', 'timeFrame': 'Week10,18,26,36', 'description': 'The control rate was defined as the proportion of patients with SBP \\< 140 mmHg and DBP \\< 90 mmHg compared to baseline'}, {'measure': 'Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs', 'timeFrame': 'Baseline, Week 10,18,26', 'description': 'The rate of use of first and second antihypertensive rescue drugs added was also assessed at all visits after week 2. The rescue drug at week 10 and 18 for those patients not achieving the required BP was amlodipine, Patients who did not achieve the required BP at week 26 were treated with hydrochlorothiazide'}]}, 'conditionsModule': {'keywords': ['Aliskiren', 'hypertension', 'concentric LVH', 'LV remodeling', 'LVMI', 'biomarkers', 'PICP', 'CT-1', 'MMP-1', 'TIMP-1', 'AnxA5', 'Aldosterone', 'Essential hypertension with concentric left ventricle hypertrophy'], 'conditions': ['Hypertension', 'Left Ventricle Hypertrophy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess efficacy of aliskiren for reducing circulating levels of biomarkers of left ventricular (LV) remodeling associated with LV hypertrophy (LVH) in hypertensive patients.', 'detailedDescription': "Blood pressure was measured 10 weeks after starting treatment (visit 3). All patients who did not achieve the required blood pressure (\\<140/90 mmHg) after 8 weeks of treatment at the maximum doses of study medication were given 5 mg of amlodipine in addition to the study medication in order to reach the required BP (\\<140/90 mmHg).\n\nThe patient's blood pressure was assessed at visit 4 (week 18) and if it was still not at the required level (\\<140/90 mmHg), the dose of amlodipine was increased to 10 mg.\n\nBlood pressure was again assessed at visit 5 (week 26) and if the required values had not been reached (\\<140/90 mmHg), a 12.5 mg dose of hydrochlorothiazide (HCTZ) was prescribed"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with hypertension\n* Confirmed concentric left ventricular hypertrophy:\n* LVMI \\> 49.2 g/m2.7 for men and \\>46.7 g/m2.7 for women\n* Relative wall thickness \\> 0.42\n\nExclusion Criteria:\n\n* Sever or secondary HTN\n* LV ejection fraction of \\<40%\n* Patient with compelling indication to ACEIs or ARBs or BB\n* History of myocardial infarction, coronary artery bypass surgery, PTC intervention, TIA or stroke within 6 months of study entry\n* History of collagenopathies, osteopathy\n* eGFR \\<30 ml/min/1,73 m2, serum potassium ≥5,2 mEq/L\n* Morbid obesity (BMI ≥ 42 kg/m2\n* Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01176032', 'acronym': 'ALLMARK', 'briefTitle': 'ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'The "ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling (ALLMARK)" Study', 'orgStudyIdInfo': {'id': 'CSPP100AES02'}, 'secondaryIdInfos': [{'id': '2009-016735-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aliskiren', 'description': 'Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks. In addition to the study medication, amlodipine 5mg was given to patients who did not achieve the required blood pressure (\\<140/90 mmHg) after 8 weeks of treatment at the maximum doses of study medication. At week 18 the dose of amlodipine was increased to 10mg if the required level (\\<140/90 mmHg) was still not achieved.\n\nHCTZ 12.5mg was prescribed at week 26 if the required values (\\<140/90 mmHg) had not been reached.', 'interventionNames': ['Drug: Aliskiren', 'Drug: Amlodipine', 'Drug: Hydrochlorothiazide (HCTZ)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lostaran', 'description': 'Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks. In addition to the study medication, amlodipine 5mg was given to patients who did not achieve the required blood pressure (\\<140/90 mmHg) after 8 weeks of treatment at the maximum doses of study medication. At week 18 the dose of amlodipine was increased to 10mg if the required level (\\<140/90 mmHg) was still not achieved.\n\nHCTZ 12.5mg was prescribed at week 26 if the required values (\\<140/90 mmHg) had not been reached.', 'interventionNames': ['Drug: Losartan', 'Drug: Amlodipine', 'Drug: Hydrochlorothiazide (HCTZ)']}], 'interventions': [{'name': 'Aliskiren', 'type': 'DRUG', 'otherNames': ['Rasilez'], 'description': 'Aliskiren 300 mg film coated tablets', 'armGroupLabels': ['Aliskiren']}, {'name': 'Losartan', 'type': 'DRUG', 'description': 'Losartan 100 mg tablets', 'armGroupLabels': ['Lostaran']}, {'name': 'Amlodipine', 'type': 'DRUG', 'description': 'Amlodipine 5mg was given to patients who did not achieve the required blood pressure (\\<140/90 mmHg) after 8 weeks (visit 3)of treatment at the maximum doses of study medication in addition to the study medication in order to reach the required BP. at visit 4 (week 18) the dose of amlodipine was increased to 10mg if the required level (\\<140/90 mmHg) was still not achieved.', 'armGroupLabels': ['Aliskiren', 'Lostaran']}, {'name': 'Hydrochlorothiazide (HCTZ)', 'type': 'DRUG', 'description': 'HCTZ 12.5mg was prescribed at visit 5 (week 26) if the required values (\\<140/90 mmHg) had not been reached.', 'armGroupLabels': ['Aliskiren', 'Lostaran']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11540', 'city': 'Sanlúcar de Barrameda', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.77808, 'lon': -6.3515}}, {'zip': '41009', 'city': 'Seville', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41013', 'city': 'Seville', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41710', 'city': 'Utrera', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Novartis Investigative 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Investigative Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46014', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '08006', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '39008', 'city': 'Santander', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}, {'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}