Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT07073820
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-01-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2025-07-09', 'studyFirstSubmitQcDate': '2025-07-09', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to week 111'}, {'measure': 'Number of Participants With Change From Baseline in Laboratory Tests Results', 'timeFrame': 'Baseline up to week 111'}, {'measure': 'Number of Participants With Vital Sign Abnormalities', 'timeFrame': 'Baseline up to week 111'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters', 'timeFrame': 'Baseline up to week 111'}, {'measure': 'Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration', 'timeFrame': 'Baseline up to week 104'}, {'measure': 'Minimum Observed Plasma Trough Concentration (Cmin), as data permits', 'timeFrame': 'Baseline up to week 111'}, {'measure': 'Incidence of Anti-Drug Antibody (ADA)', 'timeFrame': 'Baseline up to week 111'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C5001004', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn about the long-term safety, tolerability and effects of the study medicine (PF-07868489) for the possible treatment of PAH. PAH is a condition in which there is high blood pressure in the arteries that carry blood from the heart to the lungs. This high pressure makes it harder for the heart to pump blood through those lungs, potentially damaging the right side of the heart.\n\nThis is an open-label study. Which means that both the healthcare providers and the study participants are aware of the medicine being given. This study is also an extension study with study medicine (PF-07868489). An extension study allows patients from an earlier clinical study (also called as qualifying study) to continue participating to assess long-term benefits and safety of the medicine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'This study is seeking participants who are:\n\n* aged 18 years or older at screening of the previous study and completed the required treatment duration with PF-07868469 and other assessments at the end of that study.\n* willing and able to abide with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.\n* do not have worsening or hospitalization for worsening PAH during the qualifying study.\n* not on placement for a surgery to replace any tissue or part of the body (transplant), and planned surgery for PAH.\n* do not have an ongoing major health issue in the qualifying study, which in the opinion of the study doctor could make the participant not qualify for this study.\n* not suffering from or in the past have suffered from hepato-pulmonary syndrome (liver-related lung problem).\n* not currently prescribed or taking medicines called as GLP-1 agonist.'}, 'identificationModule': {'nctId': 'NCT07073820', 'briefTitle': 'A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 2, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF PF-07868489 ADMINISTERED TO ADULT PARTICIPANTS WITH PULMONARY ARTERIAL HYPERTENSION', 'orgStudyIdInfo': {'id': 'C5001004'}, 'secondaryIdInfos': [{'id': '2025-521155-23-00', 'type': 'REGISTRY', 'domain': 'CTIS (EU)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open Label', 'description': 'Participants will receive subcutaneous doses of PF-07868489 every 4 weeks', 'interventionNames': ['Drug: PF-07868489']}], 'interventions': [{'name': 'PF-07868489', 'type': 'DRUG', 'description': 'Participants will receive subcutaneous doses of PF-07868489 every 4 weeks', 'armGroupLabels': ['Open Label']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Pfizer CT.gov Call Center', 'role': 'CONTACT', 'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}