Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-02-25 @ 8:31 PM
Study NCT ID:
NCT01756833
Status:
COMPLETED
Last Update Posted:
2021-11-26
First Post:
2012-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000783', 'term': 'Aneurysm'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004318', 'term': 'Doxycycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mterrin@som.umaryland.edu', 'phone': '410-706-6139', 'title': 'Michael L. Terrin, MDCM, MPH, Contact Principal Investigator', 'organization': 'University of Maryland School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Follow-up was limited to two years for most patients and results could differ with longer term follow-up.'}}, 'adverseEventsModule': {'timeFrame': 'Two years', 'description': 'Adverse Events were classified without regard to specific Adverse Event Term.', 'eventGroups': [{'id': 'EG000', 'title': 'Doxycycline', 'description': '100 mg capsules, twice a day, for a period of two years.\n\nDoxycycline: 100 mg po bid', 'otherNumAtRisk': 129, 'deathsNumAtRisk': 129, 'otherNumAffected': 121, 'seriousNumAtRisk': 129, 'deathsNumAffected': 3, 'seriousNumAffected': 70}, {'id': 'EG001', 'title': 'Placebo', 'description': '100 mg capsules, twice a day, for a period of two years.\n\nPlacebo: capsule identical to the doxycycline capsule', 'otherNumAtRisk': 125, 'deathsNumAtRisk': 125, 'otherNumAffected': 111, 'seriousNumAtRisk': 125, 'deathsNumAffected': 4, 'seriousNumAffected': 71}], 'otherEvents': [{'term': 'Frequent joint pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 84, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 79, 'numAffected': 79}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Frequent gastric or intestinal upset', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 58, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 56, 'numAffected': 56}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Frequent bleeding or bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 47, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 54, 'numAffected': 54}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Frequent spells of dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 37, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Skin rash or hives', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 41, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Visual disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 43, 'numAffected': 43}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Moderate to severe sunburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Frequent headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Tooth discoloration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Other symptom requiring study drug dose adjustment or discontinuation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Serious or Unexpected Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 16, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Serious or Unexpected Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 27, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 24, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Serious or Unexpected Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 18, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Serious or Unexpected Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Serious or Unexpected Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Serious or Unexpected Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Serious or Unexpected Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Serious or Unexpected Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Serious or Unexpected Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 21, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Serious or Unexpected Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Serious or Unexpected Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 23, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 22, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Serious or Unexpected Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 36, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 45, 'numAffected': 38}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Serious or Unexpected Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Serious or Unexpected Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Serious or Unexpected Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Serious or Unexpected Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Serious or Unexpected Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Serious or Unexpected Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Serious or Unexpected Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Serious or Unexpected Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Serious or Unexpected Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference in Z-score for Rank of Maximum Transverse Diameter (MTD) Regressed on Z-score at Baseline to Assess Growth in Abdominal Aortic Aneurysm MTD Determined by CT Scans at Two-year Follow-up and Baseline (Pre-randomization).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': '100 mg capsules, twice a day, for a period of two years.\n\nDoxycycline: 100 mg po bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': '100 mg capsules, twice a day, for a period of two years.\n\nPlacebo: capsule identical to the doxycycline capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0262', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-0.0258', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.71', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.07', 'pValueComment': 'Two prespecified interim analyses for efficacy performed when 1/3 \\& 2/3 of primary outcome available, significance level, 1-sided, alpha=.0005. Final analysis 1-sided, alpha=.024. Futility analysis performed when \\~2/3 primary outcome was available.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.035', 'groupDescription': 'Null hypothesis: normal score of MTD at follow-up adjusted for baseline and gender in doxycycline assigned patients - normal score of MTD at follow-up adjusted for baseline and gender in placebo assigned patients = 0.\n\nSample size: The criterion ("alpha") set for statistical significance was 1-sided .025; use of this level means that the inference from the test result will be the same as the inference from 2-sided testing at the .05 significance level.', 'statisticalMethod': 'ANCOVA on normal scores', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'For the primary analysis, diameters at baseline were ranked from smallest to largest (ranks 1-254). At the 2-year follow-up, ranks 1 through 225 were assigned to the diameters of surviving patients with no aneurysm repair (with missing values estimated by multiple imputation), ranks 226 through 247 were assigned to surviving patients who underwent aneurysm repair (in order of longest to shortest time from randomization to repair), and ranks 248 through 254 were assigned to patients who died (in order of longest to shortest time from randomization to death). Each rank was converted to a normal score corresponding to the value on the standard normal curve (z score) of its percentile among all 254 ranks. The primary analysis was based on linear regression of the change in normal scores from baseline to 2 years. Independent variables were baseline normal score, sex, and a dichotomous variable for the randomly assigned treatment group (0 for placebo, 1 for doxycycline).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and two years from randomization (when patients were late in returning for visits, their data were used up to three years).', 'description': 'Diameters were ranked from smallest to largest. Worse ranks were assigned to surviving patients who underwent aneurysm repair (in order of longest to shortest time from randomization to repair), and worst ranks were assigned to patients who died (in order likewise). Each rank was converted to a z-score corresponding to the value on the standard normal curve of its percentile. The primary analysis was based on linear regression of the change in z-scores from baseline to 2 years. Independent variables were baseline z-score, sex, and a dichotomous variable for the randomly assigned treatment group (0 for placebo, 1 for doxycycline). Missing values were multiply imputed. Higher score corresponds to less favorable outcome. There is no scale associated with these z-scores; the absolute z-scores have no biological meaning or clinically relevant threshold. A z-score of 0 corresponds to the median rank. The maximum and minimum z-scores are +2.41 and -2.41. See References in Protocol Section.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants refers to the number for whom CT scans were available.'}, {'type': 'SECONDARY', 'title': 'Maximum Transverse Diameter, cm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': '100 mg capsules, twice a day, for a period of two years.\n\nDoxycycline: 100 mg po bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': '100 mg capsules, twice a day, for a period of two years.\n\nPlacebo: capsule identical to the doxycycline capsule'}], 'classes': [{'title': 'Maximum Transverse Diameter, cm 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.40', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '4.40', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Maximum Transverse Diameter, cm 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.49', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '4.48', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Maximum Transverse Diameter, cm 2 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.61', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '4.61', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': 'Maximum Transverse Diameter, cm Baseline to 2 year change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Six months, one year, and two years (when patients were late in returning for visits their data were used up to three years).', 'description': 'Secondary outcomes will derive from central, Imaging Core Laboratory analyses of the CT scans performed every six months on patients and from the clinical follow-up of randomized patients, from clinical observation, local laboratory findings, study visit quality of life assessments, and from biomarker analyses to be performed in the Biomarkers Core Laboratory (e.g., changes from initial matrix metalloproteinase (MMP-9) levels, and matrix metalloproteinase (MMP-9) levels at 24 months). When patients were late in returning for visits their data were used up to three years.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients for whom any follow-up CT scans of the abdomen and pelvis were obtained.'}, {'type': 'SECONDARY', 'title': 'Volume, cm^3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': '100 mg capsules, twice a day, for a period of two years.\n\nDoxycycline: 100 mg po bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': '100 mg capsules, twice a day, for a period of two years.\n\nPlacebo: capsule identical to the doxycycline capsule'}], 'classes': [{'title': 'Volume, cm^3 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '102.90', 'spread': '26.19', 'groupId': 'OG000'}, {'value': '100.40', 'spread': '26.27', 'groupId': 'OG001'}]}]}, {'title': 'Volume, cm^3 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '106.00', 'spread': '29.13', 'groupId': 'OG000'}, {'value': '105.00', 'spread': '28.28', 'groupId': 'OG001'}]}]}, {'title': 'Volume, cm^3 2 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '113.60', 'spread': '34.91', 'groupId': 'OG000'}, {'value': '111.20', 'spread': '33.14', 'groupId': 'OG001'}]}]}, {'title': 'Volume, cm^3 Baseline to 2 year change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.60', 'spread': '14.38', 'groupId': 'OG000'}, {'value': '19.16', 'spread': '15.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Six months, one year, and two years (when patients were late in returning for visits their data were used up to three years).', 'description': 'Secondary outcomes will derive from central, Imaging Core Laboratory analyses of the CT scans performed every six months on patients and from the clinical follow-up of randomized patients, from clinical observation, local laboratory findings, study visit quality of life assessments, and from biomarker analyses to be performed in the Biomarkers Core Laboratory (e.g., changes from initial matrix metalloproteinase (MMP-9) levels, and matrix metalloproteinase (MMP-9) levels at 24 months). When patients were late in returning for visits their data were used up to three years.', 'unitOfMeasure': 'cm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients for whom any follow-up CT scans of the abdomen and pelvis were obtained.'}, {'type': 'SECONDARY', 'title': 'MMP-9, ng/ml', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': '100 mg capsules, twice a day, for a period of two years.\n\nDoxycycline: 100 mg po bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': '100 mg capsules, twice a day, for a period of two years.\n\nPlacebo: capsule identical to the doxycycline capsule'}], 'classes': [{'title': 'MMP-9, ng/ml 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.9', 'spread': '85.3', 'groupId': 'OG000'}, {'value': '61.9', 'spread': '61.8', 'groupId': 'OG001'}]}]}, {'title': 'MMP-9, ng/ml 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.0', 'spread': '90.1', 'groupId': 'OG000'}, {'value': '61.0', 'spread': '91.5', 'groupId': 'OG001'}]}]}, {'title': 'MMP-9, ng/ml 1 year, 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.8', 'spread': '43.9', 'groupId': 'OG000'}, {'value': '68.3', 'spread': '86.7', 'groupId': 'OG001'}]}]}, {'title': 'MMP-9, ng/ml 2 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.8', 'spread': '54.8', 'groupId': 'OG000'}, {'value': '52.8', 'spread': '41.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Six months, one year, 18 months, and two years (when patients were late in returning for visits their data were used up to three years).', 'description': 'Secondary outcomes will derive from central, Imaging Core Laboratory analyses of the CT scans performed every six months on patients and from the clinical follow-up of randomized patients, from clinical observation, local laboratory findings, study visit quality of life assessments, and from biomarker analyses to be performed in the Biomarkers Core Laboratory (e.g., changes from initial matrix metalloproteinase (MMP-9) levels, and matrix metalloproteinase (MMP-9) levels at 24 months). When patients were late in returning for visits their data were used up to three years.\n\nAnalysis of hs-CRP will be performed using an immunoturbidimetric latex agglutination method (K-assay \\[KAI-60\\], Kamiya Biomedical Co., Seattle, WA).', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients for whom any follow-up CT scans of the abdomen and pelvis were obtained.'}, {'type': 'SECONDARY', 'title': 'CRP, mg/l', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': '100 mg capsules, twice a day, for a period of two years.\n\nDoxycycline: 100 mg po bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': '100 mg capsules, twice a day, for a period of two years.\n\nPlacebo: capsule identical to the doxycycline capsule'}], 'classes': [{'title': 'CRP, mg/l 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '10.7', 'groupId': 'OG001'}]}]}, {'title': 'CRP, mg/l 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '6.9', 'groupId': 'OG001'}]}]}, {'title': 'CRP, mg/l 1 year, 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '15.1', 'groupId': 'OG001'}]}]}, {'title': 'CRP, mg/l 2 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.9', 'spread': '15.6', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '5.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Six months, one year, 18 months, and two years (when patients were late in returning for visits their data were used up to three years).', 'description': 'Secondary outcomes will derive from central, Imaging Core Laboratory analyses of the CT scans performed every six months on patients and from the clinical follow-up of randomized patients, from clinical observation, local laboratory findings, study visit quality of life assessments, and from biomarker analyses to be performed in the Biomarkers Core Laboratory (e.g., changes from initial matrix metalloproteinase (MMP-9) levels, and matrix metalloproteinase (MMP-9) levels at 24 months). When patients were late in returning for visits their data were used up to three years.\n\nPlasma MMP-9 concentrations will be measured by an ELISA, two-site sandwich method that is commercially available (R \\& D Systems, Quantikine, DMP900).', 'unitOfMeasure': 'mg/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients for whom any follow-up CT scans of the abdomen and pelvis were obtained.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Aneurysm Rupture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': '100 mg capsules, twice a day, for a period of two years.\n\nDoxycycline: 100 mg po bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': '100 mg capsules, twice a day, for a period of two years.\n\nPlacebo: capsule identical to the doxycycline capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Two years', 'description': 'Clinically reported rupture events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Surgical Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': '100 mg capsules, twice a day, for a period of two years.\n\nDoxycycline: 100 mg po bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': '100 mg capsules, twice a day, for a period of two years.\n\nPlacebo: capsule identical to the doxycycline capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Two years', 'description': 'Clinically reported aneurysm repair.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Who Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': '100 mg capsules, twice a day, for a period of two years.\n\nDoxycycline: 100 mg po bid'}, {'id': 'OG001', 'title': 'Placebo', 'description': '100 mg capsules, twice a day, for a period of two years.\n\nPlacebo: capsule identical to the doxycycline capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Two years', 'description': 'Clinically reported deaths.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Doxycycline', 'description': '100 mg capsules, twice a day, for a period of two years.\n\nDoxycycline: 100 mg po bid'}, {'id': 'FG001', 'title': 'Placebo', 'description': '100 mg capsules, twice a day, for a period of two years.\n\nPlacebo: capsule identical to the doxycycline capsule'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '128'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '125'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Doxycycline', 'description': '100 mg capsules, twice a day, for a period of two years.\n\nDoxycycline: 100 mg po bid'}, {'id': 'BG001', 'title': 'Placebo', 'description': '100 mg capsules, twice a day, for a period of two years.\n\nPlacebo: capsule identical to the doxycycline capsule'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '71.0', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '70.9', 'spread': '7.3', 'groupId': 'BG001'}, {'value': '71.0', 'spread': '7.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '241', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Smoking Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Current Smoker', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}, {'title': 'Former Smoker', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}, {'title': 'Never Smoked', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Clinical History', 'classes': [{'title': 'Hypercholesterolemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}]}]}, {'title': 'Coronary artery disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}, {'title': 'Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': 'Chronic obstructive pulmonary disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': 'Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': 'Family history of abdominal aortic aneurysm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Atrial fibrillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Congestive Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Medications', 'classes': [{'title': 'Statin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}]}, {'title': 'Any antihypertensive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}]}, {'title': 'B-Blocker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}, {'title': 'Diuretics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}, {'title': 'Angiotensin-converting enzyme inhibitor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}, {'title': 'Calcium channel blocker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Angiotensin receptor blocker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'Aspirin or other antiplatelet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}]}, {'title': 'Daily aspirin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}]}, {'title': 'Other antiplatelet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Aneurysm Diameter (Overall)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.4', 'groupId': 'BG000'}, {'value': '4.3', 'spread': '0.4', 'groupId': 'BG001'}, {'value': '4.3', 'spread': '0.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Aneurysm values round to 4.3 cm (SD = 0.4 cm) for the total and for each of the two treatment groups.', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Aneurysm Diameter (Men)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.4', 'groupId': 'BG000'}, {'value': '4.4', 'spread': '0.4', 'groupId': 'BG001'}, {'value': '4.4', 'spread': '0.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Aneurysm diameter (cm) measured in men'}, {'title': 'Aneurysm Diameter (Women)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.3', 'groupId': 'BG000'}, {'value': '3.9', 'spread': '0.3', 'groupId': 'BG001'}, {'value': '4.0', 'spread': '0.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Aneurysm diameter (cm) measured in women'}, {'title': 'Aneurysm Volume (Overall)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '97.0', 'spread': '24.0', 'groupId': 'BG000'}, {'value': '95.8', 'spread': '24.0', 'groupId': 'BG001'}, {'value': '96.4', 'spread': '24.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm^3', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Aneurysm Volume (Men)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '99.0', 'spread': '24.3', 'groupId': 'BG000'}, {'value': '99.2', 'spread': '23.3', 'groupId': 'BG001'}, {'value': '99.1', 'spread': '23.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm^3', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Aneurysm volume (cm3) measured in men'}, {'title': 'Aneurysm Volume (Women)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '84.9', 'spread': '18.5', 'groupId': 'BG000'}, {'value': '74.3', 'spread': '15.9', 'groupId': 'BG001'}, {'value': '79.6', 'spread': '16.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm^3', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Aneurysm volume (cm3) measured in women'}, {'title': 'MMP-9 Levels (ng/ml)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54.6', 'spread': '53.2', 'groupId': 'BG000'}, {'value': '55.0', 'spread': '51.1', 'groupId': 'BG001'}, {'value': '54.8', 'spread': '52.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'MMP-9 levels (ng/ml) measured at baseline'}, {'title': 'CRP Levels, mg/l', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '13.6', 'groupId': 'BG000'}, {'value': '3.6', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '4.5', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/l', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'CRP Levels (mg/l) measured at baseline'}], 'populationDescription': 'Seven participants who were randomized had insufficient follow-up to be included in the primary analysis. There were two patients whose baseline specimens were lost in shipment reducing the total number for baseline evaluations of MMP-9 and CRP from 254 to 252.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-13', 'size': 1103175, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_003.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-07-15T14:23', 'hasProtocol': True}, {'date': '2017-03-26', 'size': 627237, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2017-12-19T13:31', 'hasProtocol': False}, {'date': '2015-02-03', 'size': 95834, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_004.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-07-15T14:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 261}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-29', 'studyFirstSubmitDate': '2012-12-20', 'resultsFirstSubmitDate': '2021-05-07', 'studyFirstSubmitQcDate': '2012-12-20', 'lastUpdatePostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-29', 'studyFirstPostDateStruct': {'date': '2012-12-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Aneurysm Rupture', 'timeFrame': 'Two years', 'description': 'Clinically reported rupture events.'}, {'measure': 'Number of Participants With Surgical Intervention', 'timeFrame': 'Two years', 'description': 'Clinically reported aneurysm repair.'}, {'measure': 'Number of Participants Who Died', 'timeFrame': 'Two years', 'description': 'Clinically reported deaths.'}], 'primaryOutcomes': [{'measure': 'Difference in Z-score for Rank of Maximum Transverse Diameter (MTD) Regressed on Z-score at Baseline to Assess Growth in Abdominal Aortic Aneurysm MTD Determined by CT Scans at Two-year Follow-up and Baseline (Pre-randomization).', 'timeFrame': 'Baseline and two years from randomization (when patients were late in returning for visits, their data were used up to three years).', 'description': 'Diameters were ranked from smallest to largest. Worse ranks were assigned to surviving patients who underwent aneurysm repair (in order of longest to shortest time from randomization to repair), and worst ranks were assigned to patients who died (in order likewise). Each rank was converted to a z-score corresponding to the value on the standard normal curve of its percentile. The primary analysis was based on linear regression of the change in z-scores from baseline to 2 years. Independent variables were baseline z-score, sex, and a dichotomous variable for the randomly assigned treatment group (0 for placebo, 1 for doxycycline). Missing values were multiply imputed. Higher score corresponds to less favorable outcome. There is no scale associated with these z-scores; the absolute z-scores have no biological meaning or clinically relevant threshold. A z-score of 0 corresponds to the median rank. The maximum and minimum z-scores are +2.41 and -2.41. See References in Protocol Section.'}], 'secondaryOutcomes': [{'measure': 'Maximum Transverse Diameter, cm', 'timeFrame': 'Six months, one year, and two years (when patients were late in returning for visits their data were used up to three years).', 'description': 'Secondary outcomes will derive from central, Imaging Core Laboratory analyses of the CT scans performed every six months on patients and from the clinical follow-up of randomized patients, from clinical observation, local laboratory findings, study visit quality of life assessments, and from biomarker analyses to be performed in the Biomarkers Core Laboratory (e.g., changes from initial matrix metalloproteinase (MMP-9) levels, and matrix metalloproteinase (MMP-9) levels at 24 months). When patients were late in returning for visits their data were used up to three years.'}, {'measure': 'Volume, cm^3', 'timeFrame': 'Six months, one year, and two years (when patients were late in returning for visits their data were used up to three years).', 'description': 'Secondary outcomes will derive from central, Imaging Core Laboratory analyses of the CT scans performed every six months on patients and from the clinical follow-up of randomized patients, from clinical observation, local laboratory findings, study visit quality of life assessments, and from biomarker analyses to be performed in the Biomarkers Core Laboratory (e.g., changes from initial matrix metalloproteinase (MMP-9) levels, and matrix metalloproteinase (MMP-9) levels at 24 months). When patients were late in returning for visits their data were used up to three years.'}, {'measure': 'MMP-9, ng/ml', 'timeFrame': 'Six months, one year, 18 months, and two years (when patients were late in returning for visits their data were used up to three years).', 'description': 'Secondary outcomes will derive from central, Imaging Core Laboratory analyses of the CT scans performed every six months on patients and from the clinical follow-up of randomized patients, from clinical observation, local laboratory findings, study visit quality of life assessments, and from biomarker analyses to be performed in the Biomarkers Core Laboratory (e.g., changes from initial matrix metalloproteinase (MMP-9) levels, and matrix metalloproteinase (MMP-9) levels at 24 months). When patients were late in returning for visits their data were used up to three years.\n\nAnalysis of hs-CRP will be performed using an immunoturbidimetric latex agglutination method (K-assay \\[KAI-60\\], Kamiya Biomedical Co., Seattle, WA).'}, {'measure': 'CRP, mg/l', 'timeFrame': 'Six months, one year, 18 months, and two years (when patients were late in returning for visits their data were used up to three years).', 'description': 'Secondary outcomes will derive from central, Imaging Core Laboratory analyses of the CT scans performed every six months on patients and from the clinical follow-up of randomized patients, from clinical observation, local laboratory findings, study visit quality of life assessments, and from biomarker analyses to be performed in the Biomarkers Core Laboratory (e.g., changes from initial matrix metalloproteinase (MMP-9) levels, and matrix metalloproteinase (MMP-9) levels at 24 months). When patients were late in returning for visits their data were used up to three years.\n\nPlasma MMP-9 concentrations will be measured by an ELISA, two-site sandwich method that is commercially available (R \\& D Systems, Quantikine, DMP900).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['abdominal', 'aortic', 'aneurysm'], 'conditions': ['Aneurysm']}, 'referencesModule': {'references': [{'pmid': '27018941', 'type': 'BACKGROUND', 'citation': 'Baxter BT, Matsumura J, Curci J, McBride R, Blackwelder WC, Liu X, Larson L, Terrin ML; N-TA(3)CT Investigators. Non-invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA(3)CT): Design of a Phase IIb, placebo-controlled, double-blind, randomized clinical trial of doxycycline for the reduction of growth of small abdominal aortic aneurysm. Contemp Clin Trials. 2016 May;48:91-8. doi: 10.1016/j.cct.2016.03.008. Epub 2016 Mar 25.'}, {'pmid': '32986071', 'type': 'BACKGROUND', 'citation': 'Lachin JM. Worst-Rank Score Methods-A Nonparametric Approach to Informatively Missing Data. JAMA. 2020 Oct 27;324(16):1670-1671. doi: 10.1001/jama.2020.7709. No abstract available.'}, {'pmid': '32453350', 'type': 'BACKGROUND', 'citation': 'Lachin JM. Nonparametric Statistical Analysis. JAMA. 2020 May 26;323(20):2080-2081. doi: 10.1001/jama.2020.5874. No abstract available.'}, {'pmid': '32453369', 'type': 'RESULT', 'citation': 'Baxter BT, Matsumura J, Curci JA, McBride R, Larson L, Blackwelder W, Lam D, Wijesinha M, Terrin M; N-TA3CT Investigators. Effect of Doxycycline on Aneurysm Growth Among Patients With Small Infrarenal Abdominal Aortic Aneurysms: A Randomized Clinical Trial. JAMA. 2020 May 26;323(20):2029-2038. doi: 10.1001/jama.2020.5230.'}, {'pmid': '34655683', 'type': 'DERIVED', 'citation': 'Olson SL, Panthofer AM, Blackwelder W, Terrin ML, Curci JA, Baxter BT, Weaver FA, Matsumura JS; Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial Investigators. Role of volume in small abdominal aortic aneurysm surveillance. J Vasc Surg. 2022 Apr;75(4):1260-1267.e3. doi: 10.1016/j.jvs.2021.09.046. Epub 2021 Oct 14.'}, {'pmid': '33957227', 'type': 'DERIVED', 'citation': 'Panthofer AM, Olson SL, Rademacher BL, Grudzinski JK, Chaikof EL, Matsumura JS; N-TA(3)CT Investigators. Anatomic eligibility for endovascular aneurysm repair preserved over 2 years of surveillance. J Vasc Surg. 2021 Nov;74(5):1527-1536.e1. doi: 10.1016/j.jvs.2021.04.044. Epub 2021 May 4.'}, {'pmid': '33595625', 'type': 'DERIVED', 'citation': 'Olson SL, Wijesinha MA, Panthofer AM, Blackwelder WC, Upchurch GR Jr, Terrin ML, Curci JA, Baxter BT, Matsumura JS. Evaluating Growth Patterns of Abdominal Aortic Aneurysm Diameter With Serial Computed Tomography Surveillance. JAMA Surg. 2021 Apr 1;156(4):363-370. doi: 10.1001/jamasurg.2020.7190.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to determine if doxycycline (100 mg bid) will inhibit (by at least 40%) the increase in greatest transverse diameter of small abdominal aortic aneurysms (3.5-5.0 cm in men, 3.5-4.5 cm in women) over a 24-month period of observation in comparison to a placebo-treated control group.', 'detailedDescription': 'N-TA\\^3CT is a randomized, double-blind, placebo-controlled test of the hypothesis that doxycycline 100 mg bid, will reduce the rate of increase of maximum transverse diameter of small (3.5-5.0 cm among men and 3.5 to 4.5 cm among women) abdominal aortic aneurysms. The primary outcome is abdominal aortic aneurysm (AAA) maximum transverse diameter determined by CT scans at two-year follow-up with allowance for baseline (pre-randomization) diameter. Based on an anticipated growth rate of 2.5 mm per year in the placebo group and the current threshold at which surgical intervention will be offered to trial participants, (5.5 cm in men, 5.0 cm in women), the upper limit of AAA size for inclusion has been set at 5.0 cm for men and 4.5 cm for women. Among these subjects, the threshold for repair would be exceeded only by those exhibiting persistent growth. Secondary outcomes will determine if doxycycline affects other measures, e.g., MMP-9 levels in plasma and whether these effects are related to aneurysm growth. Nineteen clinical sites have identified pools of over 1600 patients with small aneurysm who meet the proposed inclusion/exclusion criteria. Two hundred fifty-eight patients will be randomized to placebo or doxycycline and their aneurysms followed for change in diameter at six-month intervals using CT imaging. The alternative hypothesis is that doxycycline will inhibit the expansion rate by 40% during the two years of observation. Patients enrolling in N-TA\\^3CT must be able to give consent for their participation themselves and meet study eligibility criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients 55 years of age or older, women post-surgical menopause or at least two years since last menses if natural menopause.\n* CT scan documented infrarenal abdominal aortic aneurysm with maximum transverse diameter larger than 35 mm and no greater than 50 mm, in men, and larger than 35 mm and no greater than 45 mm in women.\n\nExclusion Criteria:\n\n* Patients will be excluded from the study if they are unable to give their own informed consent to participate.\n* have symptoms related to abdominal aortic aneurysm.\n* have other intra-abdominal vascular pathology that may require repair within 24 months (e.g., renal artery stenosis, large iliac artery aneurysms, iliac occlusive disease, aneurysmal involvement of the renal artery).\n* have had previous abdominal aortic aneurysm repair by open surgical or endovascular technique.\n* have an active malignancy with life expectancy less than two years.\n* have an allergy to tetracycline.\n* are currently or have been recently treated (previous six months) with tetracycline derivatives.\n* they are currently taking anti-seizure medicines metabolized by pathways influenced by doxycycline (e.g., carbamazepine, phenytoin, and barbiturates).\n* stage II hypertension (patients whose blood pressure is persistently in the range of systolic \\> 160 mm Hg or diastolic \\> 100 mm Hg despite primary physician's best effort to achieve adequate therapy.\n* have dialysis dependent renal failure or impending dialysis treatment for renal insufficiency.\n* have a chronic infection requiring long-term (\\> 2 weeks) antibiotics.\n* have known genetic syndromes responsible for the abdominal aortic aneurysm (e.g., Marfan's Syndrome).\n* are under treatment with systemic immunosuppressive agents.\n* could become pregnant.\n* are not good candidates for clinical trial participation.\n* are enrolled in another clinical trial."}, 'identificationModule': {'nctId': 'NCT01756833', 'acronym': 'N-TA^3CT', 'briefTitle': 'Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA^3CT)', 'orgStudyIdInfo': {'id': 'HP-00051170'}, 'secondaryIdInfos': [{'id': 'R01AG037120', 'link': 'https://reporter.nih.gov/quickSearch/R01AG037120', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Doxycycline', 'description': '100 mg capsules, twice a day, for a period of two years.', 'interventionNames': ['Drug: Doxycycline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '100 mg capsules, twice a day, for a period of two years.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Doxycycline', 'type': 'DRUG', 'otherNames': ['doxycycline hyclate', 'Vibramycin', 'Oracea', 'Adoxa', 'Atridox and others'], 'description': '100 mg po bid', 'armGroupLabels': ['Doxycycline']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['capsule containing inert filler'], 'description': 'capsule identical to the doxycycline capsule', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona Medical Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85745', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Carondelet Heart & Vascular Institute', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Cardiac and Vascular Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida Health Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconness Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Medical Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '49770', 'city': 'Petoskey', 'state': 'Michigan', 'country': 'United States', 'facility': 'McLaren Northern Michigan', 'geoPoint': {'lat': 45.37334, 'lon': -84.95533}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Omaha VAMC', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Portland VAMC', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Medical Center', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Health Sciences Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah VAMC', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Michael L Terrin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, Baltimore'}, {'name': 'Bernard T Baxter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}, {'name': 'Jonathan Matsumura, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin Medical Center'}, {'name': 'John Curci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Michael Terrin', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}