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Brianza","20900",{"type":60,"coordinates":684},[685,686],9.27246,45.58005,{"lat":686,"lon":685},{"facility":689,"status":42,"city":690,"state":42,"zip":691,"country":661,"countryCode":662,"cosmosGeoPoint":692,"geoPoint":696,"contacts":42},"Centro Cardiologico Monzino IRCCS ( Site 0306)","Milan","20138",{"type":60,"coordinates":693},[694,695],12.59836,42.78235,{"lat":695,"lon":694},{"facility":698,"status":42,"city":699,"state":42,"zip":700,"country":661,"countryCode":662,"cosmosGeoPoint":701,"geoPoint":705,"contacts":42},"Fondazione IRCCS Policlinico San Matteo ( Site 0302)","Pavia","27100",{"type":60,"coordinates":702},[703,704],9.15917,45.19205,{"lat":704,"lon":703},{"facility":707,"status":42,"city":708,"state":708,"zip":709,"country":710,"countryCode":711,"cosmosGeoPoint":712,"geoPoint":716,"contacts":42},"Instituto Nacional de Cardiología -Ignacio Chavez ( Site 0651)","Mexico City","14080","Mexico","MX",{"type":60,"coordinates":713},[714,715],-99.12766,19.42847,{"lat":715,"lon":714},{"facility":718,"status":42,"city":719,"state":720,"zip":721,"country":710,"countryCode":711,"cosmosGeoPoint":722,"geoPoint":726,"contacts":42},"Consultorio 1020 Hospital Angeles Xalapa ( Site 0654)","Xalapa","Veracruz","91193",{"type":60,"coordinates":723},[724,725],-96.91589,19.53124,{"lat":725,"lon":724},{"facility":728,"status":42,"city":729,"state":42,"zip":730,"country":710,"countryCode":711,"cosmosGeoPoint":731,"geoPoint":735,"contacts":42},"Operadora de Hospitales Angeles. S.A. de C.V. -Sucursal Lomas ( Site 0653)","Huixquilucan","52763",{"type":60,"coordinates":732},[733,734],-99.35016,19.35985,{"lat":734,"lon":733},{"facility":737,"status":42,"city":738,"state":739,"zip":740,"country":741,"countryCode":742,"cosmosGeoPoint":743,"geoPoint":747,"contacts":42},"Christchurch Hospital ( Site 0201)","Christchurch","Canterbury","8011","New Zealand","NZ",{"type":60,"coordinates":744},[745,746],172.63333,-43.53333,{"lat":746,"lon":745},{"facility":749,"status":42,"city":750,"state":42,"zip":751,"country":741,"countryCode":742,"cosmosGeoPoint":752,"geoPoint":756,"contacts":42},"Greenlane Clinical Centre ( Site 0203)","Auckland","1051",{"type":60,"coordinates":753},[754,755],174.76349,-36.84853,{"lat":755,"lon":754},{"facility":758,"status":42,"city":759,"state":760,"zip":761,"country":762,"countryCode":763,"cosmosGeoPoint":764,"geoPoint":768,"contacts":42},"Krakowski Szpital Specjalistyczny im. Jana Pawa II-Oddzial Kliniczny Chorob Serca i Naczyn z Pododd","Krakow","Lesser Poland Voivodeship","31-202","Poland","PL",{"type":60,"coordinates":765},[766,767],19.93658,50.06143,{"lat":767,"lon":766},{"facility":770,"status":42,"city":771,"state":772,"zip":773,"country":762,"countryCode":763,"cosmosGeoPoint":774,"geoPoint":778,"contacts":42},"Specjalistyczny Szpital im. Dr Alfreda Sokolowskiego w Walbrzychu ( Site 0351)","Wałbrzych","Lower Silesian Voivodeship","58-309",{"type":60,"coordinates":775},[776,777],16.28432,50.77141,{"lat":777,"lon":776},{"facility":780,"status":42,"city":781,"state":782,"zip":783,"country":762,"countryCode":763,"cosmosGeoPoint":784,"geoPoint":788,"contacts":42},"Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie ( Site 0352)","Lublin","Lublin Voivodeship","20-954",{"type":60,"coordinates":785},[786,787],22.57009,51.25058,{"lat":787,"lon":786},{"facility":790,"status":42,"city":791,"state":792,"zip":793,"country":794,"countryCode":795,"cosmosGeoPoint":796,"geoPoint":800,"contacts":42},"Scientific Research Institute Complex Problems Cardiovascular Disease ( Site 0403)","Kemerovo","Kemerovo Oblast","650002","Russia","RU",{"type":60,"coordinates":797},[798,799],86.10435,55.35417,{"lat":799,"lon":798},{"facility":802,"status":42,"city":803,"state":804,"zip":805,"country":794,"countryCode":795,"cosmosGeoPoint":806,"geoPoint":810,"contacts":42},"Almazov National Medical Research Centre of the Ministry of Health ( Site 0402)","Saint Petersburg","Sankt-Peterburg","197341",{"type":60,"coordinates":807},[808,809],30.31413,59.93863,{"lat":809,"lon":808},{"facility":812,"status":42,"city":813,"state":814,"zip":815,"country":816,"countryCode":817,"cosmosGeoPoint":818,"geoPoint":822,"contacts":42},"Akademiska sjukhuset ( Site 0453)","Uppsala","Uppsala County","751 85","Sweden","SE",{"type":60,"coordinates":819},[820,821],17.63889,59.85882,{"lat":821,"lon":820},{"facility":824,"status":42,"city":825,"state":826,"zip":827,"country":816,"countryCode":817,"cosmosGeoPoint":828,"geoPoint":832,"contacts":42},"Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0452)","Gothenburg","Västra Götaland County","413 45",{"type":60,"coordinates":829},[830,831],11.96679,57.70716,{"lat":831,"lon":830},{"facility":834,"status":42,"city":835,"state":836,"zip":837,"country":838,"countryCode":42,"cosmosGeoPoint":839,"geoPoint":843,"contacts":42},"Ege Universitesi Hastanesi-Cardilogy Department ( Site 0504)","Bornova","İzmir","35100","Turkey (Türkiye)",{"type":60,"coordinates":840},[841,842],27.2399,38.47921,{"lat":842,"lon":841},{"facility":845,"status":42,"city":846,"state":42,"zip":847,"country":838,"countryCode":42,"cosmosGeoPoint":848,"geoPoint":852,"contacts":42},"Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0510)","Ankara","06100",{"type":60,"coordinates":849},[850,851],32.85427,39.91987,{"lat":851,"lon":850},{"facility":854,"status":42,"city":855,"state":42,"zip":856,"country":838,"countryCode":42,"cosmosGeoPoint":857,"geoPoint":861,"contacts":42},"Akdeniz Uni.Tip Fakultesi Saglik Uygulama ve Arastirma Merkezi ( Site 0508)","Antalya","07059",{"type":60,"coordinates":858},[859,860],30.69556,36.90812,{"lat":860,"lon":859},{"facility":863,"status":42,"city":864,"state":42,"zip":865,"country":838,"countryCode":42,"cosmosGeoPoint":866,"geoPoint":870,"contacts":42},"Eskisehir Osmangazi Uni. Tip Fakultesi Hastanesi ( Site 0506)","Eskişehir","26040",{"type":60,"coordinates":867},[868,869],30.52056,39.77667,{"lat":869,"lon":868},{"facility":872,"status":42,"city":873,"state":42,"zip":874,"country":838,"countryCode":42,"cosmosGeoPoint":875,"geoPoint":879,"contacts":42},"Istanbul Uni. Kardiyoloji Enstitusu ( Site 0502)","Istanbul","34096",{"type":60,"coordinates":876},[877,878],28.94966,41.01384,{"lat":878,"lon":877},{"facility":881,"status":42,"city":873,"state":42,"zip":882,"country":838,"countryCode":42,"cosmosGeoPoint":883,"geoPoint":885,"contacts":42},"Istanbul Universitesi Istanbul Tip Fakultesi ( Site 0509)","34390",{"type":60,"coordinates":884},[877,878],{"lat":878,"lon":877},{"facility":887,"status":42,"city":873,"state":42,"zip":888,"country":838,"countryCode":42,"cosmosGeoPoint":889,"geoPoint":891,"contacts":42},"Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0501)","34899",{"type":60,"coordinates":890},[877,878],{"lat":878,"lon":877},{"facility":893,"status":42,"city":894,"state":42,"zip":895,"country":838,"countryCode":42,"cosmosGeoPoint":896,"geoPoint":900,"contacts":42},"Dokuz Eylul University Faculty of Medicine ( Site 0505)","Izmir","35330",{"type":60,"coordinates":897},[898,899],27.13838,38.41273,{"lat":899,"lon":898},{"facility":902,"status":42,"city":903,"state":904,"zip":905,"country":906,"countryCode":907,"cosmosGeoPoint":908,"geoPoint":912,"contacts":42},"Golden Jubilee National Hospital ( Site 0556)","Glasgow","Glasgow City","G81 4DY","United Kingdom","UK",{"type":60,"coordinates":909},[910,911],-4.25763,55.86515,{"lat":911,"lon":910},{"facility":914,"status":42,"city":915,"state":916,"zip":917,"country":906,"countryCode":907,"cosmosGeoPoint":918,"geoPoint":922,"contacts":42},"Royal Brompton and Harefield NHS Trust ( Site 0553)","London","London, City of","SW3 6NP",{"type":60,"coordinates":919},[920,921],-0.12574,51.50853,{"lat":921,"lon":920},{"facility":924,"status":42,"city":915,"state":916,"zip":925,"country":906,"countryCode":907,"cosmosGeoPoint":926,"geoPoint":928,"contacts":42},"Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 0554)","W12 0HS",{"type":60,"coordinates":927},[920,921],{"lat":921,"lon":920},{"facility":930,"status":42,"city":931,"state":932,"zip":933,"country":906,"countryCode":907,"cosmosGeoPoint":934,"geoPoint":938,"contacts":42},"The Freeman Hosp.Newcastle upon Tyne Hosp NHS Trust ( Site 0552)","Newcastle upon Tyne","Newcastle Upon Tyne","NE7 7DN",{"type":60,"coordinates":935},[936,937],-1.61396,54.97328,{"lat":937,"lon":936},{"type":940,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100418707","phase-2-a-study-of-the-efficacy-and-safety-of-frespaciguat-mk-5475-in-participants-with-pulmonary-arterial-hypertension-insignia-pah-phase-23-study-of-an-inhaled-sgc-stimulator-in-pah-mk-5475-007-100418707",true,"NCT04732221","A Study of the Efficacy and Safety of Frespaciguat (MK-5475) in Participants With Pulmonary Arterial Hypertension (INSIGNIA-PAH: Phase 2\u002F3 Study of an Inhaled sGC Stimulator in PAH) (MK-5475-007)","A Phase 2\u002F3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults With Pulmonary Arterial Hypertension","Inclusion Criteria:\n\n* Pulmonary arterial hypertension (PAH) in one of the following groups:\n\n  * Idiopathic PAH\n  * Heritable PAH\n  * Drug and toxin-induced PAH\n  * PAH associated with connective tissue disease, HIV infection, or congenital heart disease.\n* Diagnosis of PAH documented by right heart catheterization (RHC).\n* Eligibility RHC meeting all of the following criteria:\n\n  * Mean pulmonary artery pressure (mPAP) ≥25 mmHg\n  * Pulmonary vascular resistance (PVR) of ≥3 Wood units\n  * Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤15 mmHg.\n* World Health Organization functional class (WHO-FC) symptoms between Class II and IV.\n* Two 6-Minute walk distance (6MWD) measurements between 150 and 500 meters, one at screening and one at randomization.\n* Stable concomitant background PAH-specific therapy.\n* Body Mass Index (BMI) between 18.5 kg\u002Fm² and 40 kg\u002Fm² .\n* Agree to be abstinent from heterosexual intercourse or use contraception during the intervention period and for at least 14 days after the last dose of study intervention.\n* Female participants may not be pregnant or breastfeeding.\n\nExclusion Criteria:\n\n* Group 2 to 5 pulmonary hypertension.\n* PAH in one of the following groups:\n\n  * Long term responders to calcium channel blockers\n  * Overt features of venous\u002Fcapillary involvement\n* Evidence of more-than-mild obstructive lung disease.\n* Evidence of more-than-mild parenchymal lung disease.\n* Evidence of more-than-mild obstructive sleep apnea (OSA) that is untreated.\n* Evidence or history of left heart disease, including any of the following:\n\n  * Left ventricular ejection fraction (LVEF) ≤45%\n  * Moderate or severe left-sided valvular disease (aortic or mitral valve stenosis or regurgitation)\n  * Significant left ventricular diastolic dysfunction on echocardiographic evaluation\n* Presence of 3 or more of the following risk factors for heart failure with preserved ejection fraction: BMI\\>30 kg\u002Fm², essential systemic hypertension, diabetes mellitus of any type, or coronary artery disease.\n* Oxygen saturation measured by pulse oximetry (SpO₂) \\\u003C90%, despite supplemental oxygen therapy.\n* Chronic renal insufficiency (eGFR \\\u003C30 mL\u002Fmin)\n* Chronic liver disease (i.e., Child-Pugh B or C), portal hypertension, cirrhosis, or significant hepatic laboratory abnormalities.\n* Current smoker or currently uses electronic cigarettes (vapes).\n* History of cancer, except: nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies which have been successfully treated, with appropriate follow up, and unlikely to recur for the duration of the study.",false,"ALL","18 Years","75 Years",{"count":953,"type":954},168,"ACTUAL","INTERVENTIONAL",[957,958],"PHASE2","PHASE3","This is a two-part (Phase 2\u002FPhase 3) study of frespaciguat, an inhaled soluble guanylate cyclase stimulator, in participants with pulmonary arterial hypertension (PAH).\n\nThe first part (Phase 2) will assess three different doses of frespaciguat compared to placebo in a base period of 12 weeks, followed by comparison of three different doses of frespaciguat during an optional 40 month extension period. The treatment dose with the best efficacy and safety profile in the phase 2 cohort base period will be selected for use in the second part (Phase 3) of the study. The primary hypothesis of Phase 2 is that at least one frespaciguat dose is superior to placebo in reducing pulmonary vascular resistance (PVR) from baseline at week 12.\n\nThe purpose of the second part (Phase 3) of the study is to confirm the efficacy, safety, and tolerability of frespaciguat at the selected dose compared to placebo during a 12 week base period followed by an extension period of up to 5 years. The primary hypothesis of Phase 3 is that frespaciguat is superior to placebo in increasing 6-minute walk distance (6MWD) from baseline at week 12. Due to sponsor's decision this phase\u002Fpart was not conducted.",[961,962],"Pulmonary Arterial Hypertension","Hypertension, Pulmonary","COMPLETED","2025-05-09",{"date":966,"type":954},"2025-05-25",{"date":968,"type":954},"2021-05-19",{"date":970,"type":954},"2024-07-02",{"name":5,"class":6},91]