Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2026-03-11 @ 11:43 PM
Study NCT ID:
NCT00644332
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
2008-03-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Open-label, Multi-center Study Evaluating the Validity, Reliability, and Responsiveness of a New Female-specific Angina Questionnaire in Women With Chronic Angina Treated With Ranolazine Extended-release Tablets (CVT 3041)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069458', 'term': 'Ranolazine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'emmanuelle.bellemin@gilead.com', 'title': 'Emmanuelle Bellemin, Senior Manager, Regulatory Affairs', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated early at 86% of targeted enrollment (172 of approximately 200 subjects).'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ranolazine', 'description': "In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.", 'otherNumAtRisk': 171, 'otherNumAffected': 34, 'seriousNumAtRisk': 171, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pubic rami fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Determine Whether the WISQ is Noninferior to the Seattle Angina Questionnaire (SAQ) With Regard to Angina Frequency Items Based on Changes From Baseline (BL) in the Angina Frequency Items of the WISQ With the SAQ Following Ranolazine Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranolazine', 'description': "In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.035', 'groupId': 'OG000', 'lowerLimit': '-0.36', 'upperLimit': '0.29'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4 Weeks', 'description': 'Changes from BL in angina frequency items following ranolazine treatment were measured. Analysis: multiple linear regression; response variable: ΔWISQ - ΔSAQ; independent variables: age and BL WISQ and SAQ scores. WISQ items: 15 points (higher=more severe state); SAQ items: 12 points (lower=more severe state). WISQ scores were recalibrated by multiplying by .75. Noninferiority was to be considered demonstrated if the lower limit of a 2-sided 95% CI for WISQ mean - SAQ mean was above the prespecified margin (WISQ vs SAQ difference of -2).', 'unitOfMeasure': 'ratio of variance', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Analysis Set'}, {'type': 'SECONDARY', 'title': 'Compare Changes From Baseline (BL) in the Physical Limitation Items of the WISQ With the SAQ Following Ranolazine Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranolazine', 'description': "In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption."}], 'classes': [{'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '11.3', 'upperLimit': '13.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4 Weeks', 'description': 'Changes from BL in stress, excitement, temperature, satiety, anger, and other limitation items following ranolazine treatment were measured. Analysis: multiple linear regression; response variable: ΔWISQ - ΔSAQ; independent variables: age and BL WISQ and SAQ scores. WISQ items: 27 points (higher=more severe state); SAQ items: 45 points (lower=more severe state). WISQ scores were recalibrated by multiplying by 15/27. Noninferiority was to be considered demonstrated if the lower limit of a 2-sided 95% CI for WISQ mean - SAQ mean was above the prespecified margin (WISQ vs SAQ difference of -2).', 'unitOfMeasure': 'SAQ scale units', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Analysis Set'}, {'type': 'SECONDARY', 'title': 'Compare Changes From Baseline (BL) in Other Like Items of the WISQ With the SAQ Following Ranolazine Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranolazine', 'description': "In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption."}], 'classes': [{'categories': [{'measurements': [{'value': '-6.0', 'groupId': 'OG000', 'lowerLimit': '-6.4', 'upperLimit': '-5.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4 Weeks', 'description': 'Changes from BL in stress, excitement, temperature, satiety, anger, and other limitation items following ranolazine treatment were measured. Analysis: multiple linear regression; response variable: ΔWISQ - ΔSAQ; independent variables: age and BL WISQ and SAQ scores. WISQ items: 27 points (higher=more severe state); SAQ items: 45 points (lower=more severe state). WISQ scores were recalibrated by multiplying by 15/27. Noninferiority was to be considered demonstrated if the lower limit of a 2-sided 95% CI for WISQ mean - SAQ mean was above the prespecified margin (WISQ vs SAQ difference of -2).', 'unitOfMeasure': 'SAQ scale units', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Analysis Set'}, {'type': 'PRIMARY', 'title': 'Evaluate the Validity of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and Nitroglycerin (NTG) Consumption Before and Following Treatment With Ranolazine Assessed as Coefficient of Determination (R^2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranolazine', 'description': "In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption."}], 'classes': [{'categories': [{'measurements': [{'value': '0.337', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 4', 'description': 'Validity of the WISQ was assessed by regression analysis. Results of this analysis are reported as the estimated coefficient of determination (R\\^2) of the WISQ Total Score at 4 weeks regressed on 4-week angina frequency, 4-week NTG use, and DASI score at 4 weeks. For mean (SEM) Baseline and Week 4 values for angina frequency and NTG use, please refer to Secondary Outcome Measures 7 and 8. For mean (SEM) Baseline and Week 4 DASI values, please refer to Secondary Outcome Measure 9.', 'unitOfMeasure': 'coefficient of determination', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Analysis Set, defined as all patients who took at least 1 dose of ranolazine and completed both baseline and postbaseline questionnaires. Partially missing questionnaire responses were imputed by the methods specified in the scoring instructions; completely missing responses were not imputed.'}, {'type': 'SECONDARY', 'title': 'Determine the Effect of Ranolazine on Angina Frequency as Measured by Patient-reported Diaries', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranolazine', 'description': "In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.9', 'spread': '0.7', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '-2.5'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '3.2', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-4.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.5', 'groupDescription': 'Mean change in angina frequency from Baseline to Week 4', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 4', 'description': 'Angina episodes were recorded by subjects in their diaries. Weekly frequency of angina episodes was calculated for the two-week baseline period and the last two weeks of the study.', 'unitOfMeasure': 'attacks per week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Analysis Set\n\nMissing values were excluded'}, {'type': 'SECONDARY', 'title': 'Determine the Effect of Ranolazine on Nitroglycerin Consumption as Measured by Patient-reported Diaries', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranolazine', 'description': "In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.5', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '-0.5'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'paramValue': '-3.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.5', 'groupDescription': 'Mean change in NTG use from Baseline to Week 4', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 4', 'description': 'Nitroglycerin use was recorded by subjects in their diaries. Weekly frequency of NTG use was calculated for the two-week baseline period and the last two weeks of the study.', 'unitOfMeasure': 'uses per week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Analysis Set\n\nMissing values were excluded'}, {'type': 'SECONDARY', 'title': 'Determine Changes From Baseline in the Duke Activity Status Index (DASI) Following Ranolazine Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranolazine', 'description': "In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '23.9', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '26.8', 'spread': '1.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'paramValue': '2.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.8', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 4', 'description': "The DASI was analyzed as mean values at baseline and Week 4. The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).", 'unitOfMeasure': 'DASI scale units', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Analysis Set'}, {'type': 'PRIMARY', 'title': "Evaluate the Reliability of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and NTG Consumption Before and Following Treatment With Ranolazine Assessed as Cronbach's Alpha Value", 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranolazine', 'description': "In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption."}], 'classes': [{'title': 'WISQ Overall', 'categories': [{'measurements': [{'value': '0.851', 'groupId': 'OG000'}]}]}, {'title': 'WISQ Angina Stability', 'categories': [{'measurements': [{'value': '0.308', 'groupId': 'OG000'}]}]}, {'title': 'WISQ Angina Frequency', 'categories': [{'measurements': [{'value': '0.794', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 4', 'description': "Reliability of the WISQ was assessed by estimating Cronbach's alpha (standardized); values of 0.7 or higher were to be considered adequate. (Standardized Cronbach's alpha is a coefficient of reliability or consistency, and is a function of the average inter-item correlation.) Cronbach's alpha was calculated for the WISQ instrument overall and for the Angina Frequency/Severity and Angina Stability subscales. Missing item responses were not imputed.", 'unitOfMeasure': 'ratio of variances', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Analysis Set'}, {'type': 'PRIMARY', 'title': 'Evaluate the Responsiveness of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and NTG Consumption Before and Following Treatment With Ranolazine Assessed by Regression Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranolazine', 'description': "In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption."}], 'classes': [{'categories': [{'measurements': [{'value': '0.080', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 4', 'description': 'Responsiveness of the WISQ was assessed as the estimated coefficient of determination (R\\^2) of the change from baseline WISQ Total Score at 4 weeks regressed on change from baseline angina frequency and change from baseline NTG use. For mean (SEM) Baseline and Week 4 values for angina frequency and NTG use, please refer to Secondary Outcome Measures 7 and 8.', 'unitOfMeasure': 'coefficient of determination', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Analysis Set'}, {'type': 'SECONDARY', 'title': 'Evaluate the Degree of Correlation Between Changes From Baseline in Items of the WISQ and SAQ With Changes From Baseline in Angina Frequency and NTG Diary Data and the DASI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranolazine', 'description': "In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption."}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 4', 'description': "The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity). The planned analysis was the amount of variation in WISQ and SAQ score changes from baseline explained by changes in angina frequency, NTG use, and DASI score assessed by multiple linear regression analysis.", 'unitOfMeasure': 'coefficient of determination', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was collected for this outcome, however, the analysis was not done.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ranolazine', 'description': "In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '172 patients were enrolled; one withdrew consent prior to starting treatment', 'groupId': 'FG000', 'numSubjects': '171'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Completion Status Unknown', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Did Not Meet Eligibility Requirements', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Could Not Attend Scheduled Visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients were enrolled at a total of 30 study sites in the US. The first patient was screened on 07 November 2007, and the last patient was screened on 06 December 2010. The last patient observation was on 20 January 2011.', 'preAssignmentDetails': 'In the 2-week qualifying phase, patients continued antianginal medications without changing dose or frequency and completed questionnaires to document angina symptoms, treatment and status. Patients who had average angina frequency of ≥ 2 attacks/week during this phase and met all enrollment criteria were enrolled in the open-label treatment phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ranolazine', 'description': "In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption."}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.6', 'spread': '12.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '171', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '143', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '29.5', 'spread': '6.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '76.7', 'spread': '17.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-29', 'studyFirstSubmitDate': '2008-03-24', 'resultsFirstSubmitDate': '2012-05-29', 'studyFirstSubmitQcDate': '2008-03-24', 'lastUpdatePostDateStruct': {'date': '2012-07-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-29', 'studyFirstPostDateStruct': {'date': '2008-03-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the Validity of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and Nitroglycerin (NTG) Consumption Before and Following Treatment With Ranolazine Assessed as Coefficient of Determination (R^2)', 'timeFrame': 'Baseline to Week 4', 'description': 'Validity of the WISQ was assessed by regression analysis. Results of this analysis are reported as the estimated coefficient of determination (R\\^2) of the WISQ Total Score at 4 weeks regressed on 4-week angina frequency, 4-week NTG use, and DASI score at 4 weeks. For mean (SEM) Baseline and Week 4 values for angina frequency and NTG use, please refer to Secondary Outcome Measures 7 and 8. For mean (SEM) Baseline and Week 4 DASI values, please refer to Secondary Outcome Measure 9.'}, {'measure': "Evaluate the Reliability of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and NTG Consumption Before and Following Treatment With Ranolazine Assessed as Cronbach's Alpha Value", 'timeFrame': 'Baseline to Week 4', 'description': "Reliability of the WISQ was assessed by estimating Cronbach's alpha (standardized); values of 0.7 or higher were to be considered adequate. (Standardized Cronbach's alpha is a coefficient of reliability or consistency, and is a function of the average inter-item correlation.) Cronbach's alpha was calculated for the WISQ instrument overall and for the Angina Frequency/Severity and Angina Stability subscales. Missing item responses were not imputed."}, {'measure': 'Evaluate the Responsiveness of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and NTG Consumption Before and Following Treatment With Ranolazine Assessed by Regression Analysis', 'timeFrame': 'Baseline to Week 4', 'description': 'Responsiveness of the WISQ was assessed as the estimated coefficient of determination (R\\^2) of the change from baseline WISQ Total Score at 4 weeks regressed on change from baseline angina frequency and change from baseline NTG use. For mean (SEM) Baseline and Week 4 values for angina frequency and NTG use, please refer to Secondary Outcome Measures 7 and 8.'}], 'secondaryOutcomes': [{'measure': 'Determine Whether the WISQ is Noninferior to the Seattle Angina Questionnaire (SAQ) With Regard to Angina Frequency Items Based on Changes From Baseline (BL) in the Angina Frequency Items of the WISQ With the SAQ Following Ranolazine Treatment', 'timeFrame': 'Baseline to 4 Weeks', 'description': 'Changes from BL in angina frequency items following ranolazine treatment were measured. Analysis: multiple linear regression; response variable: ΔWISQ - ΔSAQ; independent variables: age and BL WISQ and SAQ scores. WISQ items: 15 points (higher=more severe state); SAQ items: 12 points (lower=more severe state). WISQ scores were recalibrated by multiplying by .75. Noninferiority was to be considered demonstrated if the lower limit of a 2-sided 95% CI for WISQ mean - SAQ mean was above the prespecified margin (WISQ vs SAQ difference of -2).'}, {'measure': 'Compare Changes From Baseline (BL) in the Physical Limitation Items of the WISQ With the SAQ Following Ranolazine Treatment', 'timeFrame': 'Baseline to 4 Weeks', 'description': 'Changes from BL in stress, excitement, temperature, satiety, anger, and other limitation items following ranolazine treatment were measured. Analysis: multiple linear regression; response variable: ΔWISQ - ΔSAQ; independent variables: age and BL WISQ and SAQ scores. WISQ items: 27 points (higher=more severe state); SAQ items: 45 points (lower=more severe state). WISQ scores were recalibrated by multiplying by 15/27. Noninferiority was to be considered demonstrated if the lower limit of a 2-sided 95% CI for WISQ mean - SAQ mean was above the prespecified margin (WISQ vs SAQ difference of -2).'}, {'measure': 'Compare Changes From Baseline (BL) in Other Like Items of the WISQ With the SAQ Following Ranolazine Treatment', 'timeFrame': 'Baseline to 4 Weeks', 'description': 'Changes from BL in stress, excitement, temperature, satiety, anger, and other limitation items following ranolazine treatment were measured. Analysis: multiple linear regression; response variable: ΔWISQ - ΔSAQ; independent variables: age and BL WISQ and SAQ scores. WISQ items: 27 points (higher=more severe state); SAQ items: 45 points (lower=more severe state). WISQ scores were recalibrated by multiplying by 15/27. Noninferiority was to be considered demonstrated if the lower limit of a 2-sided 95% CI for WISQ mean - SAQ mean was above the prespecified margin (WISQ vs SAQ difference of -2).'}, {'measure': 'Determine the Effect of Ranolazine on Angina Frequency as Measured by Patient-reported Diaries', 'timeFrame': 'Baseline to Week 4', 'description': 'Angina episodes were recorded by subjects in their diaries. Weekly frequency of angina episodes was calculated for the two-week baseline period and the last two weeks of the study.'}, {'measure': 'Determine the Effect of Ranolazine on Nitroglycerin Consumption as Measured by Patient-reported Diaries', 'timeFrame': 'Baseline to Week 4', 'description': 'Nitroglycerin use was recorded by subjects in their diaries. Weekly frequency of NTG use was calculated for the two-week baseline period and the last two weeks of the study.'}, {'measure': 'Determine Changes From Baseline in the Duke Activity Status Index (DASI) Following Ranolazine Treatment', 'timeFrame': 'Baseline to Week 4', 'description': "The DASI was analyzed as mean values at baseline and Week 4. The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity)."}, {'measure': 'Evaluate the Degree of Correlation Between Changes From Baseline in Items of the WISQ and SAQ With Changes From Baseline in Angina Frequency and NTG Diary Data and the DASI', 'timeFrame': 'Baseline to Week 4', 'description': "The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity). The planned analysis was the amount of variation in WISQ and SAQ score changes from baseline explained by changes in angina frequency, NTG use, and DASI score assessed by multiple linear regression analysis."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Angina']}, 'descriptionModule': {'briefSummary': "According to the American Heart Association (AHA) 2011 update of heart disease and stroke statistics, more than 9 million adult patients in the United States (US) have angina. This update also notes that a study of 4 national cross-sectional health examination studies found that, among Americans 40 to 74 years of age, the age-adjusted prevalence of angina was higher among women than men. Per ACC/AHA guidelines, the goal of antianginal therapy is the complete or near complete elimination of anginal chest pain and a return to normal activities and functional capacity. However, evaluating angina and responses to antianginal therapy is often not straightforward. This is particularly true of female patients with angina. Because angina and response to antianginal therapy may differ in men and women, an instrument designed specifically to address symptomatology in women with angina could enhance our understanding and characterization of angina and responses to therapy in this population. The current study will evaluate the validity, reliability, and responsiveness of the newly developed Women's Ischemia Symptom Questionnaire (WISQ) based on changes in angina symptomatology in a female angina population treated with ranolazine, compared with the widely used Seattle Angina Questionnaire (SAQ)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 3 months of documented history of stable angina or angina equivalents that is relieved by rest and/or sublingual NTG\n* Taking antianginal therapy with beta-blockers, and/or dihydropyridine calcium antagonists, and/or long-acting nitrates for at least 4 weeks\n* Mean angina frequency of ≥ 2 attacks per week\n* Documented clinical evidence of ischemia\n\nExclusion Criteria:\n\n* Clinically significant hepatic impairment\n* Uncontrolled clinically significant cardiac arrhythmias or a history of ventricular fibrillation, torsades de points, or other life-threatening ventricular arrhythmias not associated with acute coronary syndrome\n* Treatment with strong cytochrome P450 inhibitors including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, or saquinavir\n* Prior treatment with ranolazine\n* End-stage renal disease requiring dialysis\n* Myocardial infarction or unstable angina'}, 'identificationModule': {'nctId': 'NCT00644332', 'briefTitle': 'An Open-label, Multi-center Study Evaluating the Validity, Reliability, and Responsiveness of a New Female-specific Angina Questionnaire in Women With Chronic Angina Treated With Ranolazine Extended-release Tablets (CVT 3041)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': "An Open-label, Multi-center Study Evaluating the Validity, Reliability, and Responsiveness of a New Women's Ischemia Symptom Questionnaire in Women With Chronic Angina Treated With Ranolazine Extended-release Tablets (CVT 3041)", 'orgStudyIdInfo': {'id': 'CVT 3041'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ranolazine', 'type': 'DRUG', 'otherNames': ['Ranexa'], 'description': 'Oral dosage form.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-0007', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Cardiovascular Consultants, Ltd.', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Cardiology Consultants of Orange County', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Access Clinical Trials/Cardiovascular Research Institute (ACT/CVRI)', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Escondido Cardiology Associates', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92691', 'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Mission Internal Medical Group', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'zip': '80120-5654', 'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'facility': 'South Denver Cardiology Associates, PC', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Guerra Cardiology', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville Center for Clinical Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'St. Luke Cardiology Associates', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32250', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville Heart Center, PA', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32258', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville Heart Center, PA', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University & Grady Health System', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '83686', 'city': 'Nampa', 'state': 'Idaho', 'country': 'United States', 'facility': 'Mercy Physician Group Cardiology', 'geoPoint': {'lat': 43.54072, 'lon': -116.56346}}, {'zip': '60015', 'city': 'Bannockburn', 'state': 'Illinois', 'country': 'United States', 'facility': 'North Shore Cardiology', 'geoPoint': {'lat': 42.19336, 'lon': -87.86646}}, {'zip': '62052', 'city': 'Jerseyville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Gateway Cardiology, P.C.', 'geoPoint': {'lat': 39.12005, 'lon': -90.32845}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Northern Indiana Research Alliance', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '41101', 'city': 'Ashland', 'state': 'Kentucky', 'country': 'United States', 'facility': "Ashland Hospital Corporation d/b/a King's Daughters Medical Center", 'geoPoint': {'lat': 38.47841, 'lon': -82.63794}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville, Division of Cardiovascular Medicine', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '63128', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Gateway Cardiology, P.C.', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68506', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Integrated Cardiology Consultants, LLC d.b.a. Bryan LGH Heart Institute', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '12205', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Associates in Cardiology', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '10128', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Total Heart Care, PC', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Lindner Clinical Trial Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43608', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'St. Vincent Mercy Medical Center, Cardiac Research', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '74006', 'city': 'Bartlesville', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'BlueStem Cardiology', 'geoPoint': {'lat': 36.74731, 'lon': -95.98082}}, {'zip': '15009', 'city': 'Beaver', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Tri-State Medical Group, Cardiology, Sewickley Valley Medical Group, Cardiology', 'geoPoint': {'lat': 40.69534, 'lon': -80.30478}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Cardiology Consultants of Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Nanette K. Wenger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}, {'name': 'Noel Bairey Merz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}