Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:46 PM
Study NCT ID:
NCT01114360
Status:
COMPLETED
Last Update Posted:
2015-12-18
First Post:
2010-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Melatonin and Nighttime Blood Pressure in African Americans-8 mg Study
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': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'frahbar@emory.edu', 'phone': '404-727-2590', 'title': 'Frederic Rahbari-Oskoui, Associate Professor of Medicine', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 weeks on each arm.', 'eventGroups': [{'id': 'EG000', 'title': 'Melatonin', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).', 'otherNumAtRisk': 36, 'otherNumAffected': 17, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).', 'otherNumAtRisk': 36, 'otherNumAffected': 18, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}, {'term': 'Daytime drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}, {'term': 'Early Morning Wakening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}, {'term': 'Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}, {'term': 'Heart palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Nighttime Systolic Blood Pressure (SBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).'}], 'classes': [{'categories': [{'measurements': [{'value': '126.6', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '125.3', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.075', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The null hypothesis is that there is no interaction between the order of randomization and primary outcomes.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two-way repeated measures mixed model ANOVA.', 'testedNonInferiority': False}, {'pValue': '0.75', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At the end of 4 weeks', 'description': 'The nighttime systolic blood pressure (SBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements were reported.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.'}, {'type': 'SECONDARY', 'title': 'Mean Nighttime Mean Arterial Pressure (MAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).'}], 'classes': [{'categories': [{'measurements': [{'value': '92.9', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '92.6', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.79', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At the end of 4 weeks', 'description': "Nighttime mean arterial pressure (MAP) is the average blood pressure in the subject's arteries during one cardiac cycle (one complete heartbeat) at night. It is calculated using the formula, MAP = 1/3(SBP-DBP)+DBP; where SBP is the systolic blood pressure and DBP is the diastolic blood pressure. Means of multiple measurements were reported", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.'}, {'type': 'SECONDARY', 'title': 'Mean Nighttime Heart Rate (HR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).'}], 'classes': [{'categories': [{'measurements': [{'value': '75.4', 'spread': '2', 'groupId': 'OG000'}, {'value': '76.2', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At the end of 4 weeks', 'description': 'Nighttime heart rate is number of pulsations of the heart per unit of time during nighttime sleep. It is measured in beats per minute (bpm). Ambulatory blood pressure monitoring was used to calculate the heart rate. Means of multiple measurements were reported', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.'}, {'type': 'SECONDARY', 'title': 'Mean Daytime Systolic Blood Pressure (SBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).'}], 'classes': [{'categories': [{'measurements': [{'value': '135.13', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '133.9', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.64', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At the end of 4 weeks', 'description': 'The daytime systolic blood pressure was calculated as the average systolic blood pressure during daytime period based on 24hour ambulatory blood pressure monitoring. Means of multiple measurements were reported', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.'}, {'type': 'SECONDARY', 'title': 'Mean Daytime Diastolic Blood Pressure (DBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received 8mg time release melatonin for 4 weeks (either before or after exposure to 4 weeks of placebo).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received placebo for four weeks either before or after 4 weeks of exposure to 8mg daily dose of time release melatonin).'}], 'classes': [{'categories': [{'measurements': [{'value': '85.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '86.2', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.89', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At the end of 4 weeks', 'description': 'The daytime diastolic blood pressure was calculated as the average diastolic blood pressure during the daytime period based on 24 hour ambulatory blood pressure monitoring. Means of multiple measurements were reported', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.'}, {'type': 'SECONDARY', 'title': 'Mean Daytime Mean Arterial Pressure (MAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure placebo).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).'}], 'classes': [{'categories': [{'measurements': [{'value': '102.2', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '102.1', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.97', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At the end of 4 weeks', 'description': "Daytime mean arterial pressure (MAP) is the average blood pressure in the subject's arteries during one cardiac cycle (one complete heartbeat) during the day. It is calculated using the formula, MAP = 1/3(SBP-DBP)+DBP; where SBP is the systolic blood pressure and DBP is the diastolic blood pressure. Means of multiple measurements were reported.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.'}, {'type': 'SECONDARY', 'title': 'Mean Daytime Heart Rate (HR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '84.6', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At the end of 4 weeks', 'description': 'Daytime heart rate is the number of the pulsations of the heart per unit of time during the day. It is measured in beats per minute (bpm). Ambulatory blood pressure monitoring was used to calculate the heart rate. Means of multiple measurements were reported', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.'}, {'type': 'PRIMARY', 'title': 'Mean Nighttime Diastolic Blood Pressure (DBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '76.2', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.75', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The null hypothesis is that there is no interaction between the order of randomization and primary outcomes.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At the end of 4 weeks', 'description': 'The nighttime diastolic blood pressure (DBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements were reported', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.'}, {'type': 'SECONDARY', 'title': 'Urinary Dopamine Excretion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).'}], 'classes': [{'categories': [{'measurements': [{'value': '140.9', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '137.8', 'spread': '13.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.71', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Friedman', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At the end of 4 weeks', 'description': 'The rate of urinary dopamine excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.', 'unitOfMeasure': 'ng/ml/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.'}, {'type': 'SECONDARY', 'title': 'Urinary Noradrenaline Excretion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received placebo for four weeks ((either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '19.0', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.38', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Friedman', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At the end of 4 weeks', 'description': 'The rate of urinary noradrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.', 'unitOfMeasure': 'ng/ml/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.'}, {'type': 'SECONDARY', 'title': 'Urinary Adrenaline Excretion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.75', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '2.02', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Friedman', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At the end of 4 weeks', 'description': 'The rate of urinary adrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.', 'unitOfMeasure': 'ng/ml/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '40 patients were enrolled in the study. 4 subjects did not complete the study. 36 patients completed the study and were their own controls.'}, {'type': 'SECONDARY', 'title': 'Plasma E-Selectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8mg time release melatonin).'}], 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '38.9', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.96', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At the end of 4 weeks', 'description': 'E-Selectin is a marker of endothelial function. Levels of e-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.'}, {'type': 'SECONDARY', 'title': 'Plasma P-Selectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of placebo) in a crossover design.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received placebo for four weeks (either before or after exposure to 8mg time release melatonin for 4 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '97.02', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '82.7', 'spread': '7.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At the end of 4 weeks', 'description': 'P-Selectin is a marker of endothelial function. Levels of p-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.'}, {'type': 'SECONDARY', 'title': 'Total Sleep Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received 8mg time release melatonin for 4 weeks followed by 4 weeks of placebo.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received placebo for four weeks followed by 8mg time release melatonin for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '399.8', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '412.2', 'spread': '11.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.52', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At the end of 4 weeks', 'description': 'The total sleep time will be measured by polysomnography (PSG) using an Embla polysomnograph. The nocturnal total sleep time (TST) or the the total number of minutes in any stage of sleep during the major nocturnal sleep period was measured by PSG.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.'}, {'type': 'SECONDARY', 'title': 'Nocturnal Dipping of Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received 8mg of time release melatonin or placebo for the first 4 weeks and were then switched to receive either placebo or 8mg of time release melatonin for an additional 4 weeks without any wash out period in between.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received 8mg of time release melatonin or placebo for the first 4 weeks and were then switched to receive either placebo or 8mg of time release melatonin for an additional 4 weeks without any wash out period in between'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '6.14', 'spread': '1.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the end of 4 weeks', 'description': 'Nocturnal dipping is the mean nighttime to mean daytime systolic and diastolic blood pressure ratios, or the percentage drop in nocturnal SBP compared to day time SBP. Night was defined as 10:00 PM through 5:59 AM. This ratio is calculated by the ambulatory blood pressure readings.', 'unitOfMeasure': 'percentage ratio in night/day SBP', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Melatonin-related Side Effect.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of treatment with placebo).\n\nPatients were their own controls (cross over design). 40 subjects were randomized to each of the two study arms (total=40). 4 subjects did not complete the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received placebo for four weeks (either before or after 4 weeks of treatment with melatonin).\n\nPatients were their own controls (cross over design). 40 subjects were randomized to each of the two study arms (total=40). 4 subjects did not complete the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.2', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 4 weeks of treatment', 'unitOfMeasure': 'percentage of total number of patients', 'reportingStatus': 'POSTED', 'populationDescription': '37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo/Melatonin', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received 8mg of placebo for 4 weeks first, followed by 8 mg of time-released melatonin for 4 weeks.'}, {'id': 'FG001', 'title': 'Melatonin/Placebo', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received 8 mg of time released melatonin at bed time for 4 weeks, followed by 8 mg of placebo at bedtime for an additional 4 weeks.'}], 'periods': [{'title': 'Intervention 1 (4 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Intervention 2 (4 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '80 patients were screened. 43 patients stopped study participation prior to randomization either due to screen failure or because the decided not to pursue the study procedures.\n\n37 patients were randomized. There was 1 dropout, and 36 patients completed both arms of the study.', 'preAssignmentDetails': 'After signing the ICF and going through screening procedures, 43 patients stopped study participation prior to randomization either due to screen failure or because the decided not to pursue the study procedures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \\>115 mmHg received 8mg of time release melatonin or placebo for the first 4 weeks and were then switched to receive either placebo or 8mg of time release melatonin for an additional 4 weeks without any wash out period in between.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-15', 'studyFirstSubmitDate': '2010-04-29', 'resultsFirstSubmitDate': '2015-09-15', 'studyFirstSubmitQcDate': '2010-04-30', 'lastUpdatePostDateStruct': {'date': '2015-12-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-15', 'studyFirstPostDateStruct': {'date': '2010-05-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Nighttime Systolic Blood Pressure (SBP)', 'timeFrame': 'At the end of 4 weeks', 'description': 'The nighttime systolic blood pressure (SBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements were reported.'}, {'measure': 'Mean Nighttime Diastolic Blood Pressure (DBP)', 'timeFrame': 'At the end of 4 weeks', 'description': 'The nighttime diastolic blood pressure (DBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements were reported'}], 'secondaryOutcomes': [{'measure': 'Mean Nighttime Mean Arterial Pressure (MAP)', 'timeFrame': 'At the end of 4 weeks', 'description': "Nighttime mean arterial pressure (MAP) is the average blood pressure in the subject's arteries during one cardiac cycle (one complete heartbeat) at night. It is calculated using the formula, MAP = 1/3(SBP-DBP)+DBP; where SBP is the systolic blood pressure and DBP is the diastolic blood pressure. Means of multiple measurements were reported"}, {'measure': 'Mean Nighttime Heart Rate (HR)', 'timeFrame': 'At the end of 4 weeks', 'description': 'Nighttime heart rate is number of pulsations of the heart per unit of time during nighttime sleep. It is measured in beats per minute (bpm). Ambulatory blood pressure monitoring was used to calculate the heart rate. Means of multiple measurements were reported'}, {'measure': 'Mean Daytime Systolic Blood Pressure (SBP)', 'timeFrame': 'At the end of 4 weeks', 'description': 'The daytime systolic blood pressure was calculated as the average systolic blood pressure during daytime period based on 24hour ambulatory blood pressure monitoring. Means of multiple measurements were reported'}, {'measure': 'Mean Daytime Diastolic Blood Pressure (DBP)', 'timeFrame': 'At the end of 4 weeks', 'description': 'The daytime diastolic blood pressure was calculated as the average diastolic blood pressure during the daytime period based on 24 hour ambulatory blood pressure monitoring. Means of multiple measurements were reported'}, {'measure': 'Mean Daytime Mean Arterial Pressure (MAP)', 'timeFrame': 'At the end of 4 weeks', 'description': "Daytime mean arterial pressure (MAP) is the average blood pressure in the subject's arteries during one cardiac cycle (one complete heartbeat) during the day. It is calculated using the formula, MAP = 1/3(SBP-DBP)+DBP; where SBP is the systolic blood pressure and DBP is the diastolic blood pressure. Means of multiple measurements were reported."}, {'measure': 'Mean Daytime Heart Rate (HR)', 'timeFrame': 'At the end of 4 weeks', 'description': 'Daytime heart rate is the number of the pulsations of the heart per unit of time during the day. It is measured in beats per minute (bpm). Ambulatory blood pressure monitoring was used to calculate the heart rate. Means of multiple measurements were reported'}, {'measure': 'Urinary Dopamine Excretion Rate', 'timeFrame': 'At the end of 4 weeks', 'description': 'The rate of urinary dopamine excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.'}, {'measure': 'Urinary Noradrenaline Excretion Rate', 'timeFrame': 'At the end of 4 weeks', 'description': 'The rate of urinary noradrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.'}, {'measure': 'Urinary Adrenaline Excretion Rate', 'timeFrame': 'At the end of 4 weeks', 'description': 'The rate of urinary adrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.'}, {'measure': 'Plasma E-Selectin', 'timeFrame': 'At the end of 4 weeks', 'description': 'E-Selectin is a marker of endothelial function. Levels of e-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Plasma P-Selectin', 'timeFrame': 'At the end of 4 weeks', 'description': 'P-Selectin is a marker of endothelial function. Levels of p-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Total Sleep Time', 'timeFrame': 'At the end of 4 weeks', 'description': 'The total sleep time will be measured by polysomnography (PSG) using an Embla polysomnograph. The nocturnal total sleep time (TST) or the the total number of minutes in any stage of sleep during the major nocturnal sleep period was measured by PSG.'}, {'measure': 'Nocturnal Dipping of Blood Pressure', 'timeFrame': 'At the end of 4 weeks', 'description': 'Nocturnal dipping is the mean nighttime to mean daytime systolic and diastolic blood pressure ratios, or the percentage drop in nocturnal SBP compared to day time SBP. Night was defined as 10:00 PM through 5:59 AM. This ratio is calculated by the ambulatory blood pressure readings.'}, {'measure': 'Percentage of Participants With Melatonin-related Side Effect.', 'timeFrame': 'After 4 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Melatonin', 'Hypertension', 'Blood Pressure', 'Cardiovascular', 'Sleep', 'Nighttime', 'Nocturnal', 'Catecholamines', 'Sympathetic Nervous System', 'Endothelial function', 'African American'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This purpose of this study is to test the effect of oral melatonin supplementation (8 mg per night for 4 weeks) on nighttime blood pressure in African Americans with a history of elevated nighttime blood pressure.', 'detailedDescription': 'The main outcome of interest is the mean nighttime blood pressure. The investigator is also trying to see the mechanism of action of melatonin on blood pressure by analyzing data from sleep studies to see if melatonin lowers blood pressure by providing a better quality of sleep or is that independent of the quality of sleep.\n\nThe investigator is also looking into the effect of melatonin on sympathetic nervous system by measuring urinary catecholamines.\n\nFinally, the investigator is looking into changes in vascular biology markers (P-selectin and e-selectin) on melatonin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females ages 18 to 64\n* Prior history of elevated nighttime blood pressure (BP) ((systolic blood pressure (SBP) \\>115 mmHg))\n* Taking no more than 2 antihypertensive medications\n* African-American race (self-defined by the participant)\n\nExclusion Criteria:\n\n* Secondary forms of hypertension\n* Presence of other diseases requiring treatment with BP lowering medications\n* Known cardiovascular disease (including history of angina pectoris, heart failure, presence of a cardiac pacemaker, history of myocardial infarction or revascularization procedure, or cerebrovascular disease, including stroke and transient ischemic attacks)\n* Diabetes mellitus (type 1 or 2)\n* Cancer/Malignancy other than nonmelanoma skin cancer\n* Primary renal disease\n* Serum creatinine \\> 1.5 mg/dL in men or \\> 1.4mg/dL in women\n* Severe anemia\n* Liver enzymes \\> 2.5 times upper limits of normal\n* Hepatitis B, Hepatitis C, or HIV positive as assessed by questionnaire\n* Current treatment with or regular use of calcium channel blocking agents, cyclooxygenase-2 or COX2-inhibitors, oral contraceptives, estrogen, sildenafil, vardenafil, tadalafil, antidepressants, corticosteroids, or warfarin\n* Current use of melatonin or any sleep aids containing melatonin.\n* Regular consumption (1 or more times per week) of any of the following of Vitamin methyl B12, St. Johns Wort, Feverfew, black and white mustard seeds, wolf berry seed\n* Severe Sleep apnea\n* Night work\n* Women who are pregnant, breast-feeding, attempting conception, or planning to attempt conception over the next 6 months.'}, 'identificationModule': {'nctId': 'NCT01114360', 'briefTitle': 'Melatonin and Nighttime Blood Pressure in African Americans-8 mg Study', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Melatonin and Nighttime Blood Pressure in African Americans- 8 mg Study', 'orgStudyIdInfo': {'id': 'IRB00021300'}, 'secondaryIdInfos': [{'id': '1R21AT004509-01A2', 'link': 'https://reporter.nih.gov/quickSearch/1R21AT004509-01A2', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Melatonin', 'description': 'African-American subjects with mild to moderate essential hypertension will be given 8mg time release melatonin for 4 weeks. (either before or after placebo exposure).', 'interventionNames': ['Drug: Melatonin', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'African-American subjects with mild to moderate essential hypertension will be given placebo for 4 weeks (either before or after exposure to melatonin)', 'interventionNames': ['Drug: Melatonin', 'Drug: Placebo']}], 'interventions': [{'name': 'Melatonin', 'type': 'DRUG', 'description': 'Melatonin (N-acetyl-5-methoxytryptamine) is an indoleamine compound. Subjects will receive 8 mg time-release melatonin pills, orally, once per night for 4 weeks.', 'armGroupLabels': ['Melatonin', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects received placebo pills (3 pills of 8 mg each) to be taken orally once per night for 4 weeks.', 'armGroupLabels': ['Melatonin', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Frederic F Rahbari Oskoui, MD, MSCR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}, {'name': 'Arlene Chapman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}, {'name': 'Donald Bliwise, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Frederic Rahbari-Oskoui, MD, MSCR', 'investigatorAffiliation': 'Emory University'}}}}