A PHASE III, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-TITRATION STUDY TO ASSESS THE EFFICACY, SAFETY AND PHARMACOKINETICS OF INTRAVENOUS CONIVAPTAN (VAPRISOL®) IN PEDIATRIC SUBJECTS WITH EUVOLEMIC OR HYPERVOLEMIC HYPONATREMIA

Astellas Pharma Global Development, Inc. (APGD-US),0 个研究点目标入组 0 人开始时间: 2013年1月9日最近更新: 2023年9月4日

试验速览

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•1. INSTITUTIONAL REVIEW BOARD (IRB)/INDEPENDENT ETHICS COMMITTEE (IEC)-APPROVED WRITTEN INFORMED CONSENT AND PRIVACY LANGUAGE AS PER NATIONAL REGULATIONS (E.G., HIPAA AUTHORIZATION FOR U.S. SITES) MUST BE OBTAINED FROM THE SUBJECT OR LEGALLY AUTHORIZED REPRESENTATIVE PRIOR TO ANY STUDY-RELATED PROCEDURES (INCLUDING WITH DRAWAL OF PROHIBITED MEDICATION, IF APPLICABLE). A CHILD´S ASSENT TO CONSENT SHOULD ALSO BE SIGNED BY THE SUBJECT, IF APPROPRIATE.
•2. MALE OR FEMALE SUBJECT IS 2 TO 17 YEARS OF AGE. INCLUSIVE AT SCREENING.
•3. SUBJECT HAS EUVOLEMIC 01´ HYPERVOLEMIC HYPONATREMIA ASSOCIATED WITH INAPPROPRIATE SECRETION OF ADH INCLUDING:
•PATIENTS IN POSTOPERATIVE SETTINGS INCLUDING GENERAL ORTHOPEDIC, AND CARDIAC PATIENTS (INDEPENDENT OF CONGESTIVE HEART FAILURE)
•PATIENTS UNDERGOING MECHANICAL VENTILATION OR WITH OTHER PULMONARY DISORDERS ASSOCIATED WITH HYPONATREMIA
•PATIENTS WITH NEUROLOGICAL SYMPTOMS ASSOCIATED \WITH TUMORS, TRAUMA. SUBARACHNOID TRAUMA OR INFECTIONS OF THE CENTRAL NERVOUS SYSTEM.

•1. FEMALE SUBJECT IS PREGNANT OR LACTATING.
•2. SUBJECT HAS A BODY MASS INDEX (BMI) < 3RD PERCENTILE OR> 97TH PERCENTILE FOR THEIR AGE AND STATURE (SEE APPENDICES 5 AND 6).
•3. SUBJECT HAS CLINICAL EVIDENCE OF VOLUME DEPLETION, DEHYDRATION OR HYPOVOLEMIA (E.G. ON PHYSICAL EXAM: SUNKEN EYES, DRY MOUTH, PROLONGED CAPILLARY REFILL TIME, TENTING OF THE SKIN, TACHYCARDIA, ELEVATED URINE SPECIFIC GRAVITY AND ABNORMAL MEASUREMENT OF CENTRAL VENOUS PRESSURE).
•4. SUBJECT WITH HYPOVOLEMIC HYPONATREMIA AND TRANSIENT CAUSES OF HYPONATREMIA THAT ARE LIKELY TO RESOLVE DURING THE TIME OF STUDY PARTICIPATION.
•5. SUBJECTS WITH A CAUSE OF HYPONATREMIA THAT IS MOST APPROPRIATELY CORRECTED BY ALTERNATIVE THERAPIES.
•6. SUBJECT IS EXPECTED TO RECEIVE EMERGENT TREATMENT FOR HYPONATREMIA DURING THE TREATMENT PERIOD OF THE STUDY (E.G. CEREBRAL EDEMA, OR OTHER LIFE-THREATENING CONDITIONS FOR WHICH THE SERUM SODIUM MUST BE INCREASED IMMEDIATELY AND ANY DELAY IN INCREASING SERUM SODIUM WILL RESULT IN SERIOUS CIRCUMSTANCES).
•7. SUBJECT HAS CLINICAL EVIDENCE OF HYPOTENSION: DEFINED AS ANY LOW BLOOD PRESSURE THAT THE INVESTIGATOR DECIDES IS INADEQUATE FOR TISSUE (BRAIN, KIDNEY, HEART, AND INTESTINE) PERFUSION.

发起方

Astellas Pharma Global Development, Inc. (APGD-US),