Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-26 @ 4:13 PM
Study NCT ID:
NCT01264692
Status:
COMPLETED
Last Update Posted:
2018-09-27
First Post:
2010-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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': 'C000592016', 'term': 'isobutyric acid 2-(2-((3-(4,7-dimethoxy-1H-benzoimidazol-2-yl)propyl)methylamino)ethyl)-5-phenylbicyclo(2.2.2)oct-5-en-2-yl ester'}, {'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-26', 'studyFirstSubmitDate': '2010-12-20', 'studyFirstSubmitQcDate': '2010-12-21', 'lastUpdatePostDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in mean(c) trough(d) SiDBP', 'timeFrame': 'Baseline to day 28', 'description': 'Change from baseline(b) to Day 28 (± 2 days) of Period 2 (Visit 7)in mean(c) trough(d) SiDBP.'}], 'secondaryOutcomes': [{'measure': 'Change in mean trough SiSBP.', 'timeFrame': 'Baseline to Day 28', 'description': 'Change from baseline to Day 28 (± 2 days) of Period 2 (Visit 7) in mean trough SiSBP.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Essential Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the antihypertensive efficacy of once daily oral administration of ACT 280778 on DBP compared to placebo after 28 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females aged 18 to 75 years (inclusive) at screening.\n* Body mass index (BMI) between 18 and 35 kg/m2 (inclusive) and body weight at least 50 kg at screening and prior to enrollment.\n* 12-lead ECG without clinically relevant abnormalities measured at screening.\n* Clinical chemistry, hematology, coagulation, virus serology, and urinalysis test results not deviating to a clinically relevant extent from the normal range at screening.\n* Signed informed consent in the local language prior to any study-mandated procedure\n\nExclusion Criteria:\n\n* Mean SBP \\> 180 mmHg.\n* Severe, malignant, or secondary hypertension.\n* Episodes of hypertensive crisis or hypertensive emergency within 6 months prior to enrollment.\n* Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions considered to be of clinical significance.\n* E6 Severe coronary artery disease indicated by myocardial infarction, percutaneous coronary intervention, or coronary artery bypass graft within the last 12 months prior to enrollment.\n* Angina pectoris within 6 months prior to enrollment'}, 'identificationModule': {'nctId': 'NCT01264692', 'acronym': 'REDUCE-1', 'briefTitle': 'Essential Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Idorsia Pharmaceuticals Ltd.'}, 'officialTitle': 'A Multi-center, Double-blind, Randomized, Placebo- and Active-controlled, Parallel-group, Proof-of-concept Study to Evaluate the Efficacy, Safety, and Tolerability of 10 mg of ACT-280778 in Patients With Mild to Moderate Essential Hypertension', 'orgStudyIdInfo': {'id': 'AC-067A201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'description': 'ACT-280778', 'interventionNames': ['Drug: ACT-280778']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment B', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'OTHER', 'label': 'Treatment C', 'description': 'Amlodipine', 'interventionNames': ['Drug: Amlodipine']}], 'interventions': [{'name': 'ACT-280778', 'type': 'DRUG', 'description': '10 mg once daily for 28 ± 2 days', 'armGroupLabels': ['Treatment A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo oral capsules matching ACT-280778', 'armGroupLabels': ['Treatment B']}, {'name': 'Amlodipine', 'type': 'DRUG', 'description': '10 mg once daily for 28 ± 2 days', 'armGroupLabels': ['Treatment C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18101', 'city': 'Afula', 'country': 'Israel', 'facility': 'Clinical Investigative Site 4000', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}, {'zip': '78278', 'city': 'Ashkelon', 'country': 'Israel', 'facility': 'Clinical Investigative Site 1003', 'geoPoint': {'lat': 31.66926, 'lon': 34.57149}}, {'zip': '84101', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Clinical Investigative Site 1008', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '53583', 'city': 'Giv‘atayim', 'country': 'Israel', 'facility': 'Clinical Investigative Site 1004', 'geoPoint': {'lat': 32.07225, 'lon': 34.81253}}, {'zip': '58100', 'city': 'Holon', 'country': 'Israel', 'facility': 'Clinical Investigative Site 1009', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}, {'zip': '91004', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Clinical Investigative Site 1000', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '16100', 'city': 'Nazareth', 'country': 'Israel', 'facility': 'Clinical Investigative Site 1006', 'geoPoint': {'lat': 32.70087, 'lon': 35.29719}}, {'zip': '16100', 'city': 'Nazareth', 'country': 'Israel', 'facility': 'Clinical Investigative Site 1007', 'geoPoint': {'lat': 32.70087, 'lon': 35.29719}}, {'zip': '13100', 'city': 'Safed', 'country': 'Israel', 'facility': 'Clinical Investigative Site 1005', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}, {'zip': '66872', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Clinical Investigative Site 1010', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Clinical Investigative Site 1012', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Clinical Investigative Site 3001', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Clinical InvestigativeSite 3003', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11040', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Clinical Investigative Site 4001', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11080', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Clinical Investigative Site 3004', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '18205', 'city': 'Niška Banja', 'country': 'Serbia', 'facility': 'Clinical Investigative Site 3000', 'geoPoint': {'lat': 43.29507, 'lon': 22.0057}}, {'zip': '26000', 'city': 'Pančevo', 'country': 'Serbia', 'facility': 'Clinical Investigative Site 4002', 'geoPoint': {'lat': 44.87177, 'lon': 20.64167}}, {'zip': '11080', 'city': 'Zemun', 'country': 'Serbia', 'facility': 'Clinical Investigative Site 3002', 'geoPoint': {'lat': 44.8458, 'lon': 20.40116}}], 'overallOfficials': [{'name': 'Kasra Shakeri-Nejad, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Actelion'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Idorsia Pharmaceuticals Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}