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Clinical Trial Details

Trial ID: L6771
Source ID: NCT04560998
Associated Drug: Semaglutide
Title: A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes
Acronym: STRIDE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Peripheral Arterial Disease
Interventions: DRUG: Semaglutide|DRUG: Placebo (semaglutide)
Outcome Measures: Primary: Change in maximum walking distance on a constant load treadmill test, Ratio to baseline, From baseline (week 0) to end of treatment (week 52) | Secondary: Follow-up change in maximum walking distance on a constant load treadmill test, Ratio to baseline, From baseline (week 0) to end of follow-up (week 57)|Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) score, Score on a scale. Vascular Quality of Life 6 (VascuQoL): A shorter version of the standardized, validated questionnaire, VascuQoL-25 which is used to evaluate vascular disease-specific health outcomes. VascuQol total score includes scores of Activity Domain, Symptom Domain, Pain Domain, Emotional Domain and Social Domain. Each item is rated as a 4 point response scale, with a score of 1 being the worst and a score of 4 the best possible. The total score is the sum of all 6 items scores. Each question relates to a separate domain, with a highest score of 4 which indicates best health outcome. The VascuQoL-6 is aimed specifically at PAD patients, From baseline (week 0) to end of treatment (week 52)|Change in pain-free walking distance on a constant load treadmill test, Ratio to baseline, From baseline (week 0) to end of treatment (week 52)|Follow-up change in pain-free walking distance on a constant load treadmill test, Ratio to baseline, From baseline (week 0) to end of follow-up (week 57)|Change in glycosylated haemoglobin (HbA1c), Percentage point, From baseline (week 0) to end of treatment (week 52)|Change in body weight, Kilogram, From baseline (week 0) to end of treatment (week 52)|Change in systolic blood pressure, mmHg, From baseline (week 0) to end of treatment (week 52)|Change in total cholesterol, Ratio to baseline, From baseline (week 0) to end of treatment (week 52)|Change in Low-density lipoprotein (LDL)- cholesterol, Ratio to baseline, From baseline (week 0) to end of treatment (week 52)|Change in High density lipoprotein (HDL)- cholesterol, Ratio to baseline, From baseline (week 0) to end of treatment (week 52)|Change in triglycerides, Ratio to baseline, From baseline (week 0) to end of treatment (week 52)|Change in ankle-brachial index (ABI), Ratio, From screening (week -2) to end of treatment (week 52)|Change in toe-brachial index (TBI), Ratio, From screening (week -2) to end of treatment (week 52)|Change in Walking Impairment Questionnaire (WIQ) global score, Percentage point, From baseline (week 0) to end of treatment (week 52)|Change in Short Form 36 (SF-36) physical functioning domain, Score on a scale. Short form (SF)-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health, of which will be summarised into a physical health. The physical score ranges from 24-101(where higher scores indicate a better physical capability). The domain scores will then be transformed into norm-based scores. At least seven domains must have valid data in order to calculate the physical health. To calculate physical health, the physical domain must be one of these seven domains. These scores will be summarised by domains and component summary scores by treatment and visit. A positive change in score indicates an improvement since baseline, From baseline (week 0) to end of treatment (week 52)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 792
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2020-10-01
Completion Date: 2024-07-12
Results First Posted:
Last Update Posted: 2025-01-03
Locations: Angel City Research, Inc., Los Angeles, California, 90010, United States|St. Joseph Heritage Healthcare_Mission Viejo, Mission Viejo, California, 92691, United States|Rocky Mount Reg VA Med-DN, Aurora, Colorado, 80045, United States|Clearwater Cardiovascular Consultants, Clearwater, Florida, 33756, United States|Tampa Bay Medical Research, Clearwater, Florida, 33761, United States|DMI Research, Pinellas Park, Florida, 33782, United States|University of South Florida, Tampa, Florida, 33606, United States|Aiyan Diabetes Center, Martinez, Georgia, 30907, United States|Endeavor Health Glenbook Hosp, Glenview, Illinois, 60026, United States|Cardiovascular Rsrch of NW_IN, Munster, Indiana, 46321, United States|LOUISIANA HEART Center, Covington, Louisiana, 70433, United States|Amicis Centers of Clinical Research, Saint Louis, Missouri, 63128, United States|Nebraska West Iowa Hlth System, Omaha, Nebraska, 68105, United States|Capital Area Research LLC, Camp Hill, Pennsylvania, 17011, United States|Penn Presb Med Ctr, Philadelphia, Pennsylvania, 19104, United States|Northwest Houston Cardiology, P.A., Houston, Texas, 77070, United States|Texas Tech University Health Science Center, Lubbock, Texas, 79430-8183, United States|Selma Medical Associates, Winchester, Virginia, 22601-3834, United States|Universitätsklinik für Innere Medizin Graz, Graz, 8036, Austria|Klinik Landstraße, Wien, 1030, Austria|AKH Wien, Wien, 1090, Austria|Imeldaziekenhuis Bonheiden - Thoracic and Vascular Surgery, Bonheiden, 2820, Belgium|Ziekenhuis Oost-Limburg AV - Thoracic, Genk, 3600, Belgium|UZ Gent - Thoracale Vasculaire Heelkunde, Gent, 9000, Belgium|UZ Gent_Gent_1, Gent, 9000, Belgium|AZ Groeninge - Thoracic Vascular Surgery, Kortrijk, 8500, Belgium|UZ Leuven - Hart en Vaatziekten, Leuven, 3000, Belgium|North York Diagn & Cardiac Ctr, North York, Ontario, M6B 3H7, Canada|North York Diagnostic and Cardiac Centre, North York, Ontario, M6B 3H7, Canada|ViaCar Recherche Clinique Inc, Brossard, Quebec, J4Z 2K9, Canada|Ecogene-21, Chicoutimi, Quebec, G7H 7K9, Canada|Clinique Sante Cardio MC, Montreal, Quebec, H1T 3Y7, Canada|Montreal Heart Institute, Montreal, Quebec, QC H1T 1C8, Canada|CHU de Quebec-Universite Laval, Quebec, G1L 3L5, Canada|Institut universitaire de cardiologie, Quebec, G1V 4G5, Canada|Xuanwu Hospital Capital Medical University, Beijing, Beijing, 100053, China|The first hospital of Jilin University, Changchun, Jilin, 130061, China|1st Affiliated Hosp of Xi'an JiaoTong Uni Medical College, Xi'an, Shaanxi, 710061, China|The First Affiliated Hospital of Xi'an Jiaotong University-Cardiovascular, Xi'an, Shaanxi, 710061, China|Tianjin Union Medical Center-Cardiology, Tianjin, 300121, China|Tianjin Union Medicine Centre, Tianjin, 300121, China|CTC Hodonin s.r.o., Hodonin, 695 01, Czechia|EDUMED Jaromer, Jaroměř, 55101, Czechia|Kucera, Ostrava Dubina, 700 30, Czechia|Diabetologicka ambulance Plzen, Plzen, 30100, Czechia|Kolding Sygehus Karkirurgi, Kolding, 6000, Denmark|Rigshospitalet Karkirurgisk afd. RK 3111, København Ø, 2100, Denmark|Karkirurgisk Afsnit, Viborg, 8800, Denmark|Kardiologische Praxis, Bad Homburg, 61348, Germany|Herz- und Diabeteszentrum NRW - Bad Oeynhausen, Bad Oeynhausen, 32545, Germany|Kreutzmann, Dresden, 01277, Germany|Medizinische Klinik und Poliklinik III/Angiologie TU Dresden, Dresden, 01307, Germany|MVZ CCB Frankfurt Und Main-Taunus GbR, Frankfurt, 60389, Germany|Institut für Diabetesforschung GmbH Münster - Dr. med. Rose, Münster, 48145, Germany|Gemeinschaftspraxis Haggenmiller/Jeserich, Nürnberg, 90402, Germany|Zentrum für klinische Studien Alexander Segner, Saint Ingbert-Oberwürzbach, 66386, Germany|University Hospital of Athens ATTIKON, Haidari-Athens, Attica, GR-12462, Greece|"Laiko" General Hospital of Athens, Athens, GR-11527, Greece|Konstantopouleio G.H. of Athens, "Agia Olga", Athens, GR-14233, Greece|"Hygeia" General Hospital of Athens, Athens, GR-15123, Greece|General Hospital of Chios "Skilitsio", Chios, GR82100, Greece|General Hospital of Lamia, Lamia, GR35100, Greece|'Ippokrateio' General Hospital of Thessaloniki, Thessaloniki, GR 54642, Greece|Szegedi Tudományegyetem II. sz Belgyógyászati és Kardiológia, Szeged, Csongrád-Csanád, 6725, Hungary|Léda Platán Magánklinika, Zalaegerszeg, Zala Megye, 8900, Hungary|Szent Margit Rendelőintézet Nonprofit Kft., Budapest, 1032, Hungary|Szent Imre Egyetemi Oktatókórház Angiológia, Budapest, 1115, Hungary|Semmelweis Egyetem Városmajori Szív- és Érgyógyászat, Budapest, 1122, Hungary|Coromed SMO Kft., Pécs, 7623, Hungary|Shri B D Mehta Mahavir Heart Institute, Surat, Gujarat, 395001, India|Shri B. D. Mehta Mahavir Heart Institute, Surat, Gujarat, 395001, India|Shri Krishna Hrudayalaya & Critical Care Centre, Nagpur, Maharashtra, 440012, India|Shrikrishna Hrudayalaya and critical care centre, Nagpur, Maharashtra, 440012, India|Vijan Hospital & Research Centre, Nashik, Maharashtra, 422005, India|SP Medical College, Bikaner, Rajasthan, 334003, India|Osmania General Hospital, Hyderabad, Telangana, 500012, India|Udyaan Health Care, Lucknow, Uttar Pradesh, 226002, India|Sir Ganga Ram Hospital, New Delhi, 110060, India|Akaicho Clinic, Chiba-shi, Chiba, 260-0804, Japan|New Tokyo Heart Clinic_Matsudo-shi, Chiba,, Chiba, 271-0077, Japan|Higashi Takarazuka Satoh Hospital, Hyogo, 665-0873, Japan|Nishiyamado Keiwa Hospital, Ibaraki,, 331-0133, Japan|Naka Kinen Clinic, Ibaraki, 311-0113, Japan|Omihachiman Community Medical Center_Omihachiman-shi, Siga, Omihachiman-shi, Siga, 523-0082, Japan|Minamiosaka Hospital, Osaka, 559-0012, Japan|Saitama Cardiovascular and Respiratory Center, Saitama, 360-0197, Japan|Omi Medical Center, Shiga, 525-8585, Japan|Minamino Cardiovascular Hospital, Tokyo, 192-0918, Japan|Stradini PAD, Riga, LV-1002, Latvia|Hospital Universiti Sains Malaysia, Kota Bharu, Kelantan, 16150, Malaysia|Hospital Tengku Ampuan Afzan, Kuantan, Pahang, 25100, Malaysia|University Malaya Medical Centre, Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, 59100, Malaysia|National Heart Institute, Kuala Lumpur, 50400, Malaysia|Hospital Queen Elizabeth II, Sabah, 88300, Malaysia|Sørlandet sykehus HF Kristiansand, Kristiansand, 4615, Norway|OUS, Aker, Oslo, 0586, Norway|Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET, Krakow, Malopolskie, 31-261, Poland|UniCardia & UniMedica & UniEstetica, Krakow, 31-271, Poland|Centrum Medyczne OMEDICA, Poznan, 60-111, Poland|Velocity Nova Sp. z o.o., Pulawy, 24-100, Poland|Gabinety Lekarskie LabMed, Szczecin, 71-531, Poland|DoktorA, Warszawa, 05-077, Poland|Centrum Badan Klinicznych, Wroclaw, 51-162, Poland|Hospital Vithas Sevilla, Castilleja Dela Cuesta Sevilla, 41950, Spain|Hospital Reina Sofia, Córdoba, 14004, Spain|Hospital Universitario de la Princesa, Madrid, 28006, Spain|Hospital Gregorio Marañón, Madrid, 28009, Spain|Hospital Virgen de la Macarena, Sevilla, 41009, Spain|Kärlkirurgen/kärllab, Göteborg, 413 45, Sweden|Kärlmottagningen, Uppsala, 751 85, Sweden|Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaoshiung, 807, Taiwan|Kuang Tien General Hospital, Taichung City, 433, Taiwan|China Medical University Hospital, Taichung, 404, Taiwan|National Cheng Kung University Hospital, Tainan City, 704, Taiwan|National Taiwan University Hospital, Taipei, 100, Taiwan|Taipei Veterans General Hospital, Taipei, 112, Taiwan|Chang Gung Medical Foundation - Linkou Branch, Taoyuan city, 333, Taiwan|Srinagarind Hospital, Muang, Khon Kaen, 40002, Thailand|Phramongkutklao Hospital-cardio, Bangkok, 10400, Thailand|Research Institute for Health Sciences, CMU, Chiang Mai, 50200, Thailand|Maharat Nakhon Ratchasima Hospital_Ratchasima, Nakhon Ratchasima, 30000, Thailand|Thammasat University Hospital_Pathumthani, Pathumthani, 12120, Thailand
URL: https://clinicaltrials.gov/show/NCT04560998

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress