Background intervention. Outcome Measures. To compare the SZC and placebo arms with respect to spironolactone dose.
To compare the SZC and placebo arms with respect to ability to prevent decreases in spironolactone dose. Eligibility Criteria. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. More Information. Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool.
Signed Data Sharing Agreement non-negotiable contract for data accessors must be in place before accessing requested information. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the period of study follow-up, or concurrent participation in another interventional study. Currently pregnant or breast feeding. Blood drawn in excess of a total of mL 1 unit for any reason within 30 days prior to randomization. Employees of the Sponsor involved in planning, executing, supervising, or reviewing the AZD program, clinical study site staff, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
In nations, states, or other jurisdictions that for legal or ethical reasons bar the enrollment of participants who lack capacity to provide their own informed consent, such subjects are excluded. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. Publications: CDC. Centers for Disease Control and Prevention.
Published Accessed 01 July Nat Microbiol. Epub Mar 2. Annu Rev Virol. Epub Aug Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med. FDA Resources. Arms and Interventions. Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Agree to refrain from blood donation during the course of the study.
Male participants of childbearing potential must agree to the use of condoms to ensure effective contraception with a female partner from the time of study vaccination until 3 months after vaccination.
Plan to remain living in the area for the duration of the study. Participation in another research study involving receipt of an investigational product in the 60 days preceding enrollment or planned use during the study period.
Receipt or planned receipt of any live, attenuated vaccine within 28 days before or after study vaccination. Receipt or planned receipt of any subunit or killed vaccine within 14 days before or after vaccination. Any confirmed or suspected immunosuppressive or immunodeficient state. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including urticaria, respiratory difficulty or abdominal pain.
Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema. News Repligen begins Phase 1 study of RG Content from our partners Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success.
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