Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:32 PM
Study NCT ID:
NCT01289132
Status:
COMPLETED
Last Update Posted:
2011-02-03
First Post:
2011-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Azilsartan in Participants With Mild to Moderate Uncomplicated Essential Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C521273', 'term': 'azilsartan'}, {'id': 'C077793', 'term': 'candesartan cilexetil'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 926}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-01', 'studyFirstSubmitDate': '2011-02-01', 'studyFirstSubmitQcDate': '2011-02-01', 'lastUpdatePostDateStruct': {'date': '2011-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 12).', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between sitting trough clinic diastolic blood pressure measured at week 12 or final visit from diastolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 2).', 'timeFrame': 'Baseline and Week 2.', 'description': 'The change between sitting trough clinic diastolic blood pressure measured at week 2 from diastolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.'}, {'measure': 'Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 4).', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change between sitting trough clinic diastolic blood pressure measured at week 4 from diastolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.'}, {'measure': 'Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 6).', 'timeFrame': 'Baseline and Week 6.', 'description': 'The change between sitting trough clinic diastolic blood pressure measured at week 6 from diastolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.'}, {'measure': 'Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 8).', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between sitting trough clinic diastolic blood pressure measured at week 8 from diastolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.'}, {'measure': 'Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 10).', 'timeFrame': 'Baseline and Week 10.', 'description': 'The change between sitting trough clinic diastolic blood pressure measured at week 10 from diastolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.'}, {'measure': 'Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 2).', 'timeFrame': 'Baseline and Week 2.', 'description': 'The change between sitting trough clinic systolic blood pressure measured at week 2 from systolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.'}, {'measure': 'Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 4).', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change between sitting trough clinic systolic blood pressure measured at week 4 from systolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.'}, {'measure': 'Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 6).', 'timeFrame': 'Baseline and Week 6.', 'description': 'The change between sitting trough clinic systolic blood pressure measured at week 6 from systolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.'}, {'measure': 'Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 8).', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between sitting trough clinic systolic blood pressure measured at week 8 from systolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.'}, {'measure': 'Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 10).', 'timeFrame': 'Baseline and Week 10.', 'description': 'The change between sitting trough clinic systolic blood pressure measured at week 10 from systolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.'}, {'measure': 'Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 12).', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between sitting trough clinic systolic blood pressure measured at week 12 or final visit from systolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.'}, {'measure': 'Number of Participants with a ≥20 mmHg Decrease in Sitting Trough Systolic Blood Pressure and a ≥10 mmHg Decrease in Sitting Trough Diastolic Blood Pressure.', 'timeFrame': 'Baseline and Week 12.', 'description': 'Number of participants designated as responders who have a ≥20 mmHg Decrease in sitting trough systolic blood pressure and a ≥10 mmHg Decrease in sitting trough diastolic blood pressure at week 12 or final visit from baseline.'}, {'measure': 'Number of Participants with a Sitting Trough Systolic Blood Pressure of <130 mmHg and a Sitting Trough Diastolic Blood Pressure of <85 mmHg.', 'timeFrame': 'Baseline and Week 12.', 'description': 'Number of participants designated as responders with a sitting trough systolic blood pressure of \\<130 mmHg and a sitting trough diastolic blood pressure of \\<85 mmHg at week 12 or final visit from baseline.'}, {'measure': 'Incidence of Adverse Events.', 'timeFrame': 'On occurrence (up to Week 12).', 'description': 'Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.'}, {'measure': 'Change from Baseline in Supine Systolic Blood Pressure.', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between supine systolic blood pressure measured at week 12 or final visit from baseline. Supine systolic blood pressure is measured in participants laying on their back in a face-up position once after resting for 2 minutes.'}, {'measure': 'Change from Baseline in Supine Diastolic Blood Pressure.', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between supine diastolic blood pressure measured at week 12 or final visit from baseline. Supine diastolic blood pressure is measured in participants laying on their back in a face-up position once after resting for 2 minutes.'}, {'measure': 'Change from Baseline in Standing Systolic Blood Pressure.', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between standing systolic blood pressure measured at week 12 or final visit from baseline. Standing systolic blood pressure is measured once after participants keep a standing position for 1 minute.'}, {'measure': 'Change from Baseline in Standing Diastolic Blood Pressure.', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between standing diastolic blood pressure measured at week 12 or final visit from baseline. Standing diastolic blood pressure is measured once after participants keep a standing position for 1 minute.'}, {'measure': 'Change from Baseline in Sitting Pulse Rate.', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between sitting pulse rate measured at week 12 or final visit from baseline. Sitting pulse rate is measured at least 3 times in 1- to 2-minute intervals after sitting ≥5 minutes, repeated until 2 consecutive stable measurements are obtained.'}, {'measure': 'Change from Baseline in Weight.', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between weight recorded at week 12 or final visit from baseline.'}, {'measure': 'Change from Baseline in Resting 12-lead Electrocardiogram.', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between electrocardiogram recorded at week 12 or final visit from baseline. Electrocardiogram interpreted using one of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant.'}, {'measure': 'Number of Participants with a Markedly Abnormal Blood Urea Nitrogen Clinical Laboratory Value.', 'timeFrame': 'Baseline and Week 12.', 'description': 'The number of participants with a markedly abnormal blood urea value nitrogen collected at week 12 or final visit from baseline.'}, {'measure': 'Number of Participants with a Markedly Abnormal Uric Acid Clinical Laboratory Value.', 'timeFrame': 'Baseline and Week 12.', 'description': 'The number of participants with a markedly abnormal uric acid value collected at week 12 or final visit from baseline.'}, {'measure': 'Number of Participants with a Markedly Abnormal Creatinine Clinical Laboratory Value.', 'timeFrame': 'Baseline and Week 12.', 'description': 'The number of participants with a markedly abnormal creatinine value collected at week 12 or final visit from baseline.'}, {'measure': 'Number of Participants with a Markedly Abnormal Creatine Kinase Clinical Laboratory Value.', 'timeFrame': 'Baseline and Week 12.', 'description': 'The number of participants with a markedly abnormal creatine kinase value collected at week 12 or final visit from baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Essential Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the dose-response relationships of azilsartan, once daily (QD) in participants with mild to moderate uncomplicated essential hypertension.', 'detailedDescription': 'Hypertension is known to cause multiple organ damage by being combined with not only blood pressure but also other hemodynamics, endocrinological/metabolic abnormalities and genetic factors. This becomes a medically and medical-economically significant problem in Japan The significance of early treatment of hypertension and of long-term control of blood pressure has been increasing year by year.\n\nTakeda Pharmaceutical Company Limited invented TAK-536 (azilsartan), an angiotensin II receptor blocker for decreasing blood pressure. This study investigating the efficacy and safety of azilsartan using candesartan cilexetil, a widely used antihypertensive drug, as a reference control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has mild to moderate uncomplicated essential hypertension.\n* Has a sitting diastolic blood pressure between 95 and \\<110 mmHg and sitting systolic blood pressure between 150 and \\<180 mmHg at placebo run-in period (Week -2) or randomization visit.\n\nExclusion Criteria:\n\n* Has a cardiovascular disease or symptoms\n* Has been treated with more than 3 different antihypertensives within 27 days prior to placebo run-in period.\n* Has a significant hepatic disorder, hyperkalemia, malignant tumor or significant renal impairment.'}, 'identificationModule': {'nctId': 'NCT01289132', 'briefTitle': 'Efficacy and Safety of Azilsartan in Participants With Mild to Moderate Uncomplicated Essential Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 2, Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Study of the Efficacy, Safety and Tolerability of TAK-536 in Subjects With Mild to Moderate Uncomplicated Essential Hypertension', 'orgStudyIdInfo': {'id': 'TAK-536/CCT-001'}, 'secondaryIdInfos': [{'id': 'U1111-1118-3346', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Azilsartan 5 mg QD', 'interventionNames': ['Drug: Azilsartan']}, {'type': 'EXPERIMENTAL', 'label': 'Azilsartan 10 mg QD', 'interventionNames': ['Drug: Azilsartan']}, {'type': 'EXPERIMENTAL', 'label': 'Azilsartan 20 mg QD', 'interventionNames': ['Drug: Azilsartan']}, {'type': 'EXPERIMENTAL', 'label': 'Azilsartan 40 mg QD', 'interventionNames': ['Drug: Azilsartan']}, {'type': 'EXPERIMENTAL', 'label': 'Azilsartan 80 mg QD', 'interventionNames': ['Drug: Azilsartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Candesartan Cilexetil 8 mg titrated to12 mg QD', 'interventionNames': ['Drug: Candesartan cilexetil']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo-matching tablets, orally, once daily for up to 12 weeks.', 'armGroupLabels': ['Placebo']}, {'name': 'Azilsartan', 'type': 'DRUG', 'otherNames': ['TAK-536'], 'description': 'Azilsartan 5 mg, tablets, orally, once daily for up to 12 weeks.', 'armGroupLabels': ['Azilsartan 5 mg QD']}, {'name': 'Azilsartan', 'type': 'DRUG', 'otherNames': ['TAK-536'], 'description': 'Azilsartan 10 mg, tablets, orally, once daily for up to 12 weeks.', 'armGroupLabels': ['Azilsartan 10 mg QD']}, {'name': 'Azilsartan', 'type': 'DRUG', 'otherNames': ['TAK-536'], 'description': 'Azilsartan 20 mg, tablets, orally, once daily for up to 12 weeks.', 'armGroupLabels': ['Azilsartan 20 mg QD']}, {'name': 'Azilsartan', 'type': 'DRUG', 'otherNames': ['TAK-536'], 'description': 'Azilsartan 40 mg, tablets, orally, once daily for up to 12 weeks.', 'armGroupLabels': ['Azilsartan 40 mg QD']}, {'name': 'Azilsartan', 'type': 'DRUG', 'otherNames': ['TAK-536'], 'description': 'Azilsartan 80 mg, tablets, orally, once daily for up to 12 weeks.', 'armGroupLabels': ['Azilsartan 80 mg QD']}, {'name': 'Candesartan cilexetil', 'type': 'DRUG', 'otherNames': ['Blopress®', 'TCV-116'], 'description': 'Candesartan cilexetil 8 mg, tablets, orally, once daily for 4 weeks; titrated to 12 mg, tablets, orally, once daily for up to 8 weeks.', 'armGroupLabels': ['Candesartan Cilexetil 8 mg titrated to12 mg QD']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Professor Geriatric Medicine and Nephrology', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Osaka University Graduate School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Sr. Manager, Clinical Planning', 'oldOrganization': 'Takeda Pharmaceutical Company Limited (Japan)'}}}}